Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

Adcetris (For Injection) (Intravenous) brentuximab vedotin
NDA Applicant: Seagen Inc.      BLA No.: 125388  Prod. No.: 001 Rx (50MG)

Patents	Expiration	Change
Pat. No. 11505593 Anti-VEGF protein compositions and methods for producing the same Pat. Sub. Date(s): None Claim Types: Formulation; Drug in a container	Aug 18, 2040	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Nov 10, 2029	New expiration date

Adstiladrin (For Suspension) (Intravesical) nadofaragene firadenovec-vncg
NDA Applicant: Ferring Pharmaceuticals A/S      BLA No.: 125700  Prod. No.: 001 Disc (3x10^11 viral particles (vp)/mL)

Exclusivity	Expiration	Change
Exclusivity Code: Ref. Product Exclusivity	Dec 16, 2034	New product in Purple Book

ALTUVIIIO (For Injection) (Intravenous) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
NDA Applicant: Bioverativ Therapeutics, Inc.      BLA No.: 125771  Prod. No.: 001 Rx (250IU); 002 Rx (500IU); 003 Rx (750IU); 004 Rx (1000IU); 005 Rx (2000IU); 006 Rx (3000IU); 007 Rx (4000IU)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Feb 22, 2030	New product in Purple Book

Arexvy (For Injection) (Intramuscular) Respiratory Syncytial Virus Vaccine, Adjuvanted
NDA Applicant: GlaxoSmithKline Biologicals      BLA No.: 125775  Prod. No.: 001 Rx (120UG/.5ML)

Exclusivity	Expiration	Change
Exclusivity Code: Ref. Product Exclusivity	May 3, 2035	New product in Purple Book

Avastin (Injection) (Intravenous) bevacizumab
NDA Applicant: Genentech, Inc.      BLA No.: 125085  Prod. No.: 001 Rx (100MG/4ML (25MG/ML)); 002 Rx (400MG/16ML (25MG/ML))

Patents	Expiration	Change
Pat. No. 7485704 Reducing protein A leaching during protein A affinity chromatography Pat. Sub. Date(s): None Claim Types: Process	Mar 8, 2025	New expiration date. Was previously Mar 7, 2025
Pat. No. 8460895 Method for producing recombinant proteins with a constant content of pCO.sub.2 in the medium Pat. Sub. Date(s): None Claim Types: Process	Mar 11, 2029	New expiration date. Was previously Mar 10, 2029
Pat. No. 8512983 Production of proteins in glutamine-free cell culture media Pat. Sub. Date(s): None Claim Types: Process; Cell culture medium	Jan 4, 2031	New expiration date. Was previously Jan 3, 2031
Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Pat. Sub. Date(s): None Claim Types: Process	Jul 8, 2028	New expiration date. Was previously Jul 7, 2028
Pat. No. 9441035 Cell culture media and methods of antibody production Pat. Sub. Date(s): None Claim Types: Process	Apr 23, 2034	New expiration date. Was previously Apr 22, 2034
Pat. No. 9487809 Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Pat. Sub. Date(s): None Claim Types: Process	Jan 14, 2032	New expiration date. Was previously Jan 13, 2032
Pat. No. 9714293 Production of proteins in glutamine-free cell culture media Pat. Sub. Date(s): None Claim Types: Process	Aug 6, 2030	New expiration date. Was previously Aug 5, 2030
Pat. No. 9795672 Treatment with anti-VEGF antibodies Pat. Sub. Date(s): None Claim Types: Method of use	May 28, 2024	New expiration date. Was previously May 27, 2024
Pat. No. 10011856 Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Pat. Sub. Date(s): None Claim Types: Cell culture	May 26, 2031	New expiration date. Was previously May 25, 2031
Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production Pat. Sub. Date(s): None Claim Types: Process	Mar 14, 2034	New expiration date. Was previously Mar 13, 2034
Pat. No. 10208355 Method of treatment for glioblastoma by administering a VEGF antagonist Pat. Sub. Date(s): None Claim Types: Method of use	Jul 14, 2035	New expiration date. Was previously Jul 13, 2035
Pat. No. 10274466 Elucidation of ion exchange chromatography input optimization Pat. Sub. Date(s): None Claim Types: Analytical procedure	Jul 11, 2035	New expiration date. Was previously Jul 10, 2035
Pat. No. 10336983 Method for increasing the specific production rate of eukaryotic cells Pat. Sub. Date(s): None Claim Types: Process	Jul 31, 2035	New expiration date. Was previously Jul 30, 2035
Pat. No. 10513697 CO.sub.2 profile cultivation Pat. Sub. Date(s): None Claim Types: Process	Sep 17, 2032	New expiration date. Was previously Sep 16, 2032
Pat. No. 10662237 Method to improve virus filtration capacity Pat. Sub. Date(s): None Claim Types: Process	May 26, 2031	New expiration date. Was previously May 25, 2031
Pat. No. 10676710 Cell culture compositions with antioxidants and methods for polypeptide production Pat. Sub. Date(s): None Claim Types: Process	Mar 14, 2034	New expiration date. Was previously Mar 13, 2034
Pat. No. 10704071 Decreasing lactate level and increasing polypeptide production by down regulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Pat. Sub. Date(s): None Claim Types: Vector	Aug 18, 2031	New expiration date. Was previously Aug 17, 2031
Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Pat. Sub. Date(s): None Claim Types: Process	Mar 14, 2034	New expiration date. Was previously Mar 13, 2034
Pat. No. 10906934 Protein purification methods Pat. Sub. Date(s): None Claim Types: Process	Oct 12, 2033	New expiration date. Was previously Oct 11, 2033
Pat. No. 10906986 Prevention of disulfide bond reduction during recombinant production of polypeptides Pat. Sub. Date(s): None Claim Types: Process	Jul 8, 2028	New expiration date. Was previously Jul 7, 2028

Benefix (For Injection) (Intravenous) Coagulation Factor IX (Recombinant)
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 103677  Prod. No.: 001 Rx (1000IU/ML); 002 Rx (500IU/ML); 003 Rx (250IU/ML); 004 Rx (2000IU/ML); 005 Rx (3000IU/ML)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Feb 11, 2004	New exclusivity for this product

Bivigam (Injection) (Intravenous) Immune Globulin Intravenous (Human)
NDA Applicant: ADMA Biologics, Inc.      BLA No.: 125389  Prod. No.: 001 Rx (5GM/50ML) BLA No.: 125389  Prod. No.: 002 Disc (10GM/100ML)

Patents	Expiration	Change
Pat. No. 11548932 Anti-VEGF protein compositions and methods for producing the same Pat. Sub. Date(s): None Claim Types: Process	Aug 18, 2040	New patent for this product

Breyanzi (Injection) (Intravenous) lisocabtagene maraleucel
NDA Applicant: Juno Therapeutics, Inc. a Bristol Myer-Squibb Company      BLA No.: 125714  Prod. No.: 001 Rx (4.6ML/VIAL)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Jun 24, 2029	New expiration date

Carvykti (For Injection) (Intravenous) ciltacabtagene autoleucel
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 125746  Prod. No.: 001 Rx (0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Feb 28, 2029	New exclusivity for this product
Exclusivity Code: Ref. Product Exclusivity	Feb 28, 2034	New exclusivity for this product

Cimerli (Injection) (Intravitreal) ranibizumab-eqrn
NDA Applicant: Coherus BioSciences, Inc.      BLA No.: 761165  Prod. No.: 001 Rx (10MG/ML (0.5MG/0.05ML)); 002 Rx (6MG/ML (0.3MG/0.05ML))

Exclusivity	Expiration	Change
Exclusivity Code: 1st Interchangeable Exclusivity	Oct 3, 2023	New expiration date. Was previously Date TBD

Coagadex (For Injection) (Intravenous) Coagulation Factor X (Human)
NDA Applicant: Bio Products Laboratory      BLA No.: 125506  Prod. No.: 001 Rx (500IU); 002 Rx (250IU)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Apr 14, 2030	New expiration date

Dupixent (Injection) (Subcutaneous) dupilumab
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 761055  Prod. No.: 001 Rx (300MG/2ML); 003 Rx (200MG/1.14ML); 004 Rx (300MG/2ML); 005 Rx (200MG/1.14ML); 006 Rx (100MG/0.67ML) BLA No.: 761055  Prod. No.: 002 Disc (300MG/2ML)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	May 20, 2029	New exclusivity for this product

Elahere (Injection) (Intravenous) mirvetuximab soravtansine-gynx
NDA Applicant: ImmunoGen, Inc.      BLA No.: 761310  Prod. No.: 001 Rx (100MG/20ML (5MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Nov 14, 2029	New exclusivity for this product

ELEVIDYS (Suspension) (Intravenous) delandistrogene moxeparvovec-rokl
NDA Applicant: Sarepta Therapeutics, Inc.      BLA No.: 125781  Prod. No.: 001 Rx (1.33 _10E14 vector genomes (vg)/kg/bodyweight(bw))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Jun 22, 2030	New product in Purple Book

Enjaymo (Injection) (Intravenous) sutimlimab-jome
NDA Applicant: Bioverativ Therapeutics, Inc.      BLA No.: 761164  Prod. No.: 001 Rx (1,100MG/22ML (50MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Feb 4, 2029	New exclusivity for this product

Evkeeza (Injection) (Intravenous) evinacumab-dgnb
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 761181  Prod. No.: 001 Rx (345MG/2.3ML (150MG/ML)); 002 Rx (1,200MG/8ML (150MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Mar 21, 2030	New expiration date

Eylea (Injection) (Intravitreal) aflibercept
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 125387  Prod. No.: 001 Rx (2MG/0.05ML); 002 Rx (2MG/0.05ML)

Patents	Expiration	Change
Pat. No. D961376 Packaging Pat. Sub. Date(s): None Claim Types: Ornamental appearance of device or tablet	Aug 23, 2037	New expiration date. Was previously Aug 18, 2040
Pat. No. D961377 Packaging Pat. Sub. Date(s): None Claim Types: Ornamental appearance of device or tablet	Aug 23, 2037	New expiration date. Was previously Aug 18, 2040
Pat. No. 10828354 Laser-assisted intradermal administration of active substances Pat. Sub. Date(s): None Claim Types: Method of use; Method of improving a treatment	Jan 11, 2032	New patent for this product
Pat. No. 10857231 Formulations of VEG antagonist fusion proteins and method of manufacturing them Pat. Sub. Date(s): None Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Process	Disclaimer filed on March 14, 2022	New expiration date. Was previously Disclaimer filed on March 14, 2022
Pat. No. 11433186 Devices and methods for precision dose delivery Pat. Sub. Date(s): None Claim Types: Device; Process	Dec 12, 2038	New expiration date. Was previously Aug 18, 2040
Pat. No. 11439758 Devices and methods for precision dose delivery Pat. Sub. Date(s): None Claim Types: Device	Jun 4, 2040	New expiration date. Was previously Aug 18, 2040
Pat. No. 11478588 Needle shield grip devices and related methods Pat. Sub. Date(s): None Claim Types: Device	Jul 25, 2040	New patent for this product
Pat. No. 11485770 Anti-VEGF protein compositions and methods for producing the same Pat. Sub. Date(s): None Claim Types: Cell culture medium	Aug 18, 2040	New patent for this product
Pat. No. 10828345 Use of a VEGF antagonist to treat angiogenic eye disorders Pat. Sub. Date(s): None Claim Types: Method of use	Jan 11, 2032	This patent is no longer listed for this product
Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Feb 8, 2030	New exclusivity for this product

Gammaked, Gamunex-C (Injection) (Intravenous; Subcutaneous) Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
NDA Applicant: Grifols Therapeutics LLC      BLA No.: 125046  Prod. No.: 001 Rx (2.5G); 002 Rx (5G); 003 Rx (10G); 004 Rx (1G); 005 Rx (20G); 006 Rx (40G); 007 Rx (2.5G); 008 Rx (5G); 009 Rx (10G); 010 Rx (20G); 011 Rx (40G)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Sep 12, 2015	New exclusivity for this product

Hemgenix (Injection) (Intravenous) etranacogene dezaparvovec-drlb
NDA Applicant: CSL Behring LLC      BLA No.: 125772  Prod. No.: 001 Rx (1X10E13GENOME COPIES/ML)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Nov 22, 2029	New exclusivity for this product
Exclusivity Code: Ref. Product Exclusivity	Nov 22, 2034	New exclusivity for this product

Hepagam B (Injection) (Intravenous) Hepatitis B Immune Globulin Intravenous (Human)
NDA Applicant: Kamada Ltd.      BLA No.: 125237  Prod. No.: 001 Rx (>312IU/ML); 002 Rx (>1560IU/5ML)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Apr 6, 2014	New exclusivity for this product

Herceptin (For Injection) (Intravenous) trastuzumab
NDA Applicant: Genentech, Inc.      BLA No.: 103792  Prod. No.: 002 Rx (150MG) BLA No.: 103792  Prod. No.: 001 Disc (420MG)

Patents	Expiration	Change
Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Pat. Sub. Date(s): None Claim Types: Process	Jul 8, 2028	New patent for this product
Pat. No. 10662237 Method to improve virus filtration capacity Pat. Sub. Date(s): None Claim Types: Process	May 26, 2030	New patent for this product
Pat. No. 10808037 Prevention of disulfide bond reduction during recombinant production of polypeptides Pat. Sub. Date(s): None Claim Types: Process	Jul 8, 2028	New patent for this product
Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides Pat. Sub. Date(s): None Claim Types: Process	Jul 8, 2028	New patent for this product

Imfinzi (Injection) (Intravenous) durvalumab
NDA Applicant: AstraZeneca UK Ltd      BLA No.: 761069  Prod. No.: 001 Rx (500MG/10ML (50MG/ML)); 002 Rx (120MG/2.4ML (50MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Oct 21, 2029	New expiration date
Exclusivity Code: Orphan Drug Exclusivity	Sep 2, 2029	New expiration date

Imjudo (Injection) (Intravenous) tremelimumab-actl
NDA Applicant: AstraZeneca AB      BLA No.: 761289  Prod. No.: 001 Rx (25MG/1.25ML (20MG/ML)); 002 Rx (300MG/15ML (20MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Oct 21, 2029	New exclusivity for this product

Keytruda (For Injection) (Intravenous) pembrolizumab
NDA Applicant: Merck Sharp & Dohme LLC      BLA No.: 125514  Prod. No.: 002 Rx (100MG/4ML (25MG/ML)) BLA No.: 125514  Prod. No.: 001 Disc (50MG)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Dec 3, 2028	New expiration date

Kimmtrak (Injection) (Intravenous) tebentafusp-tebn
NDA Applicant: Immunocore Limited      BLA No.: 761228  Prod. No.: 001 Rx (100MCG/0.5ML)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Jan 25, 2029	New exclusivity for this product

Kymriah (Injection) (Intravenous) tisagenlecleucel
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 125646  Prod. No.: 001 Rx (0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	May 27, 2029	New expiration date

Lamzede (For Injection) (Intravenous) velmanase alfa-tycv
NDA Applicant: Chiesi Farmaceutici S.p.A.      BLA No.: 761278  Prod. No.: 001 Rx (10MG)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Feb 16, 2030	New product in Purple Book

Lucentis (Injection) (Intravitreal) ranibizumab
NDA Applicant: Genentech, Inc.      BLA No.: 125156  Prod. No.: 001 Rx (10MG/ML (0.5MG/0.05ML)); 002 Rx (6MG/ML (0.3MG/0.05ML)); 003 Rx (10MG/ML (0.5MG/0.05ML)); 004 Rx (6MG/ML (0.3MG/0.05ML))

Patents	Expiration	Change
Pat. No. 6716602 Metabolic rate shifts in fermentations expressing recombinant proteins Pat. Sub. Date(s): None Claim Types: Process	Nov 1, 2021	New expiration date. Was previously Oct 31, 2021
Pat. No. 6828121 Bacterial host strains Pat. Sub. Date(s): None Claim Types: Bacterial strain; Process	Jul 8, 2022	New expiration date. Was previously Jul 7, 2022
Pat. No. 6921659 Protease-deficient cells Pat. Sub. Date(s): None Claim Types: Bacterial strain; Process	Oct 17, 2023	New expiration date. Was previously Oct 16, 2023
Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Pat. Sub. Date(s): None Claim Types: Process	Jul 8, 2028	New expiration date. Was previously Jul 7, 2028
Pat. No. 9765379 Harvest operations for recombinant proteins Pat. Sub. Date(s): None Claim Types: Process	Mar 10, 2034	New expiration date. Was previously Mar 9, 2034
Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production Pat. Sub. Date(s): None Claim Types: Process	Mar 14, 2034	New expiration date. Was previously Mar 13, 2034
Pat. No. 10112994 Methods of producing two chain proteins in bacteria Pat. Sub. Date(s): None Claim Types: Process	Nov 5, 2035	New expiration date. Was previously Nov 4, 2035
Pat. No. 10421984 Methods for reducing norleucine misincorporation into proteins using a microorganism comprising a mutant metA allele Pat. Sub. Date(s): None Claim Types: Process	Sep 19, 2033	New expiration date. Was previously Sep 18, 2033
Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Pat. Sub. Date(s): None Claim Types: Process	Mar 14, 2034	New expiration date. Was previously Mar 13, 2034

Lunsumio (Injection) (Intravenous) mosunetuzumab-axgb
NDA Applicant: Genentech, Inc.      BLA No.: 761263  Prod. No.: 001 Rx (1MG/ML); 002 Rx (30MG/30ML (1MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Dec 22, 2029	New product in Purple Book

Myalept (For Injection) (Subcutaneous) metreleptin
NDA Applicant: Amryt Pharmaceuticals DAC      BLA No.: 125390  Prod. No.: 001 Rx (11.3MG)

Patents	Expiration	Change
Pat. No. 11555176 Cell culture medium for eukaryotic cells Pat. Sub. Date(s): None Claim Types: Process	Jan 27, 2040	New patent for this product

N/A (Injection) (Intravenous) HPC, Cord Blood
NDA Applicant: Clinimmune Labs      BLA No.: 125391  Prod. No.: 001 Rx (5X10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25X10^6 VIABLE CD34+ CELLS)

Patents	Expiration	Change
Pat. No. 11559564 Use of a VEGF antagonist to treat angiogenic eye disorders Pat. Sub. Date(s): None Claim Types: Method of use; Dosaage regimen	Jan 11, 2032	New patent for this product
Pat. No. 11577025 Devices and methods for overfilling drug containers Pat. Sub. Date(s): None Claim Types: Process	Oct 6, 2037	New patent for this product

Nexobrid (For Topical Gel) (Topical) anacaulase-bcdb
NDA Applicant: MediWound, Ltd.      BLA No.: 761192  Prod. No.: 001 Disc (8.8% (1.94GM)); 002 Disc (8.8% (4.85GM))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Dec 28, 2029	New product in Purple Book

OMISIRGE (For Injection) (Intravenous) omidubicel-onlv
NDA Applicant: Gamida Cell Ltd.      BLA No.: 125738  Prod. No.: 001 Rx (>4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol); 002 Rx (>8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Apr 17, 2030	New product in Purple Book

Opdivo (Injection) (Intravenous) nivolumab
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125554  Prod. No.: 001 Rx (40MG/4ML (10MG/ML)); 002 Rx (100MG/10ML (10MG/ML)); 003 Rx (240MG/24ML (10MG/ML)); 004 Rx (120MG/12ML (10MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Feb 15, 2030	New expiration date
Exclusivity Code: Orphan Drug Exclusivity	May 27, 2029	New expiration date

Opdualag (Injection) (Intravenous) nivolumab and relatlimab-rmbw
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 761234  Prod. No.: 001 Rx (240MG, 80MG/20ML (12MG, 4MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Mar 18, 2029	New exclusivity for this product

Orencia (For Injection) (Intravenous; Subcutaneous) abatacept
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125118  Prod. No.: 001 Rx (250MG); 002 Rx (125MG/ML); 003 Rx (125MG/ML); 004 Rx (50MG/0.4ML); 005 Rx (87.5MG/0.7ML)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Dec 15, 2028	New exclusivity for this product

Polivy (For Injection) (Intravenous) polatuzumab vedotin-piiq
NDA Applicant: Genentech, Inc.      BLA No.: 761121  Prod. No.: 001 Rx (140MG); 002 Rx (30MG)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Apr 19, 2030	New expiration date

Prolia; Xgeva (Injection) (Subcutaneous) denosumab
NDA Applicant: Amgen Inc.      BLA No.: 125320  Prod. No.: 001 Rx (60MG/ML); 003 Rx (120MG/1.7ML (70MG/ML)) BLA No.: 125320  Prod. No.: 002 Disc (60MG/ML)

Patents	Expiration	Change
Pat. No. 7364736 Antibodies to OPGL Pat. Sub. Date(s): None Claim Types: Compound; Composition	Feb 19, 2025	New patent for this product
Pat. No. 7427659 Process for purifying proteins in a hydrophobic interaction chromatography flow-through fraction Pat. Sub. Date(s): None Claim Types: Process	Mar 15, 2025	New patent for this product
Pat. No. 7928205 Methods for refolding of recombinant antibodies Pat. Sub. Date(s): None Claim Types: Process	Feb 12, 2027	New patent for this product
Pat. No. 8058418 Polynucleotides encoding heavy and light chains of antibodies to OPGL Pat. Sub. Date(s): None Claim Types: Formulation	Nov 30, 2023	New patent for this product
Pat. No. 9012178 Dipeptides to enhance yield and viability from cell cultures Pat. Sub. Date(s): None Claim Types: Process; Cell culture	Aug 5, 2031	New patent for this product
Pat. No. 9133493 Method for culturing mammalian cells to improve recombinant protein production Pat. Sub. Date(s): None Claim Types: Process	Apr 20, 2032	New patent for this product
Pat. No. 9228168 Feed media Pat. Sub. Date(s): None Claim Types: Process; Cell culture medium	Jan 19, 2030	New patent for this product
Pat. No. 9320816 Methods of treating cell culture media for use in a bioreactor Pat. Sub. Date(s): None Claim Types: Process	Nov 14, 2030	New patent for this product
Pat. No. 9328134 Carbohydrate phosphonate derivatives as modulators of glycosylation Pat. Sub. Date(s): None Claim Types: Compound; Process	Feb 20, 2034	New patent for this product
Pat. No. 9359435 Methods for modulating mannose content of recombinant proteins Pat. Sub. Date(s): None Claim Types: Process	May 22, 2027	New patent for this product
Pat. No. 9388447 Method for culturing mammalian cells to improve recombinant protein production Pat. Sub. Date(s): None Claim Types: Process	Apr 20, 2032	New patent for this product
Pat. No. 9481901 Methods for increasing mannose content of recombinant proteins Pat. Sub. Date(s): None Claim Types: Process	May 29, 2034	New patent for this product
Pat. No. 10167492 Process for manipulating the level of glycan content of a glycoprotein Pat. Sub. Date(s): None Claim Types: Process	Dec 1, 2035	New patent for this product
Pat. No. 10513723 Decreasing ornithine production to decrease high mannose glycoform content of recombinant proteins Pat. Sub. Date(s): None Claim Types: Process	Dec 9, 2034	New patent for this product
Pat. No. 10583397 Process control systems and methods for use with filters and filtration processes Pat. Sub. Date(s): None Claim Types: Device	Jul 28, 2035	New patent for this product
Pat. No. 10822630 Process for manipulating the level of glycan content of a glycoprotein Pat. Sub. Date(s): None Claim Types: Process	Dec 1, 2035	New patent for this product
Pat. No. 10894972 Methods for increasing mannose content of recombinant proteins Pat. Sub. Date(s): None Claim Types: Cell culture medium; Process	May 29, 2034	New patent for this product
Pat. No. 11077404 Process control systems and methods for use with filters and filtration processes Pat. Sub. Date(s): None Claim Types: Device; Process	May 13, 2035	New patent for this product
Pat. No. 11098079 Charged depth filtration of antigen-binding proteins Pat. Sub. Date(s): None Claim Types: Process	Jul 21, 2037	New patent for this product
Pat. No. 11130980 Use of monensin to regulate glycosylation of recombinant proteins Pat. Sub. Date(s): None Claim Types: Process	Apr 5, 2035	New patent for this product
Pat. No. 11254963 Increasing ornithine accumulation to increase high mannose glycoform content of recombinant proteins Pat. Sub. Date(s): None Claim Types: Process	Dec 9, 2034	New patent for this product
Pat. No. 11299760 Use of monensin to regulate glycosylation of recombinant proteins Pat. Sub. Date(s): None Claim Types: Process	Oct 30, 2034	New patent for this product
Pat. No. 11434514 Methods for increasing mannose content of recombinant proteins Pat. Sub. Date(s): None Claim Types: Process	May 29, 2034	New patent for this product

Rebyota (Suspension) (Rectal) Fecal Microbiota Transplantation, Frozen Preparation
NDA Applicant: Ferring Pharmaceuticals Inc.      BLA No.: 125739  Prod. No.: 001 Rx (BETWEEN 1X10^8 AND 5X10^10CFU)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Nov 30, 2029	New product in Purple Book
Exclusivity Code: Ref. Product Exclusivity	Nov 30, 2034	New product in Purple Book

Rituxan (Injection) (Intravenous) rituximab
NDA Applicant: Genentech, Inc.      BLA No.: 103705  Prod. No.: 001 Rx (100MG/10ML (10MG/ML)); 002 Rx (500MG/50ML (10MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Dec 2, 2028	New expiration date

Rituxan (Injection) (Intravenous) rituximab
NDA Applicant: IDEC Pharmaceuticals Corp.      BLA No.: 103737  Prod. No.: 001 Disc (100MG/10ML (10MG/ML)); 002 Disc (500MG/50ML (10MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Dec 2, 2028	New expiration date

Roctavian (Injection) (Intravenous) valoctocogene roxaparvovec-rvox
NDA Applicant: Biomarin Pharmaceutical Inc.      BLA No.: 125720  Prod. No.: 001 Rx (16X 10E13GENOMES PER ML)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Jun 29, 2030	New product in Purple Book

Rystiggo (Injection) (Subcutaneous) rozanolixizumab-noli
NDA Applicant: UCB, Inc.      BLA No.: 761286  Prod. No.: 001 Rx (280MG/2ML (140MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Jun 26, 2030	New product in Purple Book

Skysona (Injection) (Intravenous) elivaldogene autotemcel
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125755  Prod. No.: 001 Rx (2-30 _ 10^6 CELL/ML)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Sep 16, 2029	New exclusivity for this product

Spevigo (Injection) (Intravenous) spesolimab-sbzo
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc.      BLA No.: 761244  Prod. No.: 001 Rx (450MG/7.5ML (60MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Sep 1, 2029	New exclusivity for this product

Stelara (Injection) (Subcutaneous) ustekinumab
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 125261  Prod. No.: 001 Rx (45MG/0.5ML); 003 Rx (45MG/0.5ML); 004 Rx (90MG/ML) BLA No.: 125261  Prod. No.: 002 Disc (90MG/ML)

Patents	Expiration	Change
Pat. No. 6902734 [Extended 425 days (1.2 years)] Anti-IL-12 antibodies and compositions thereof Pat. Sub. Date(s): None Claim Types: Compound; Composition	Sep 25, 2023	New patent for this product
Pat. No. 8852889 Cell culture process Pat. Sub. Date(s): None Claim Types: Process	Jul 6, 2032	New patent for this product
Pat. No. 9217168 Methods of cell culture Pat. Sub. Date(s): None Claim Types: Process	Mar 14, 2033	New patent for this product
Pat. No. 9475858 Cell culture process Pat. Sub. Date(s): None Claim Types: Process	Jul 6, 2032	New patent for this product
Pat. No. 9663810 Methods of cell culture Pat. Sub. Date(s): None Claim Types: Process	Mar 14, 2033	New patent for this product
Pat. No. 10961307 Methods of treating moderately to severely active ulcerative colitis by administering an anti-IL12/IL23 antibody Pat. Sub. Date(s): None Claim Types: Method of use	Sep 24, 2039	New patent for this product

Stelara (Injection) (Intravenous) ustekinumab
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 761044  Prod. No.: 001 Rx (130MG/26ML (5MG/ML))

Patents	Expiration	Change
Pat. No. 6902734 [Extended 425 days (1.2 years)] Anti-IL-12 antibodies and compositions thereof Pat. Sub. Date(s): None Claim Types: Compound; Composition	Sep 25, 2023	New patent for this product
Pat. No. 8852889 Cell culture process Pat. Sub. Date(s): None Claim Types: Process	Jul 6, 2032	New patent for this product
Pat. No. 9217168 Methods of cell culture Pat. Sub. Date(s): None Claim Types: Process	Mar 14, 2033	New patent for this product
Pat. No. 9475858 Cell culture process Pat. Sub. Date(s): None Claim Types: Process	Jul 6, 2032	New patent for this product
Pat. No. 9663810 Methods of cell culture Pat. Sub. Date(s): None Claim Types: Process	Mar 14, 2033	New patent for this product
Pat. No. 10961307 Methods of treating moderately to severely active ulcerative colitis by administering an anti-IL12/IL23 antibody Pat. Sub. Date(s): None Claim Types: Method of use	Sep 24, 2039	New patent for this product

StrataGraft (Cell Sheets) (Topical) Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
NDA Applicant: Stratatech Corporation      BLA No.: 125730  Prod. No.: 001 Rx (100CM SQUARED)

Exclusivity	Expiration	Change
Exclusivity Code: Ref. Product Exclusivity	Jun 15, 2033	New exclusivity for this product

Takhzyro (Injection) (Subcutaneous) lanadelumab-flyo
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 761090  Prod. No.: 001 Rx (300MG/2ML (150MG/ML)); 002 Rx (300MG/2ML (150MG/ML)); 003 Rx (150MG/1ML (150MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Feb 3, 2030	New expiration date

Tecentriq (Injection) (Intravenous) atezolizumab
NDA Applicant: Genentech, Inc.      BLA No.: 761034  Prod. No.: 001 Rx (1200MG/20ML (60MG/ML)); 002 Rx (840MG/14ML (60MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Dec 9, 2029	New expiration date

Tecvayli (Injection) (Subcutaneous) teclistamab-cqyv
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 761291  Prod. No.: 001 Rx (30MG/3ML (10MG/ML)); 002 Rx (153MG/1.7ML (90MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Oct 25, 2029	New exclusivity for this product

Tysabri (Injection) (Intravenous) natalizumab
NDA Applicant: Biogen Inc.      BLA No.: 125104  Prod. No.: 001 Rx (300MG/15ML (20MG/ML))

Patents	Expiration	Change
Pat. No. 10308706 Methods of preventing and removing trisulfide bonds Pat. Sub. Date(s): None Claim Types: Process	Feb 5, 2031	New expiration date. Was previously Feb 5, 2032
Pat. No. 10844416 Manganese supplementation for control of glycosylation in mammalian cell culture process Pat. Sub. Date(s): None Claim Types: Process	Jun 1, 2036	New expiration date. Was previously Jan 6, 2036

Vonvendi (For Injection) (Intravenous) von Willebrand factor (Recombinant)
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125577  Prod. No.: 001 Rx (1300IU); 002 Rx (650IU)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Jan 28, 2029	New expiration date

Vowst (Capsule) (Oral) Fecal Microbiota Spores
NDA Applicant: Seres Therapeutics, Inc.      BLA No.: 125757  Prod. No.: 001 Rx (1X10 LOG 6 AND 3X10 LOG 7CFU/TAB)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Apr 26, 2030	New product in Purple Book
Exclusivity Code: Ref. Product Exclusivity	Apr 26, 2035	New product in Purple Book

VYJUVEK (Gel) (Topical) beremagene geperpavec-svdt
NDA Applicant: Krystal Biotech, Inc.      BLA No.: 125774  Prod. No.: 001 Rx (5.0x10^9 PFU/mL)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	May 19, 2030	New product in Purple Book

Vyvgart (Injection) (Intravenous) efgartigimod alfa-fcab
NDA Applicant: Argenx BV      BLA No.: 761195  Prod. No.: 001 Rx (400MG/20ML (20MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Dec 17, 2028	New exclusivity for this product

Vyvgart Hytrulo (Injection) (Subcutaneous) efgartigimod alfa and hyaluronidase-qvfc
NDA Applicant: Argenx BV      BLA No.: 761304  Prod. No.: 001 Rx (1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Jun 20, 2030	New product in Purple Book

Xenpozyme (For Injection) (Intravenous) olipudase alfa-rpcp
NDA Applicant: Genzyme Corporation      BLA No.: 761261  Prod. No.: 001 Rx (20MG); 002 Rx (4MG)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Aug 31, 2029	New exclusivity for this product

Yescarta (Injection) (Intravenous) axicabtagene ciloleucel
NDA Applicant: Kite Pharma Inc.      BLA No.: 125643  Prod. No.: 001 Rx (2 _ 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Apr 1, 2029	New expiration date

Zynteglo (For Injection) (Intravenous) betibeglogene autotemcel
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125717  Prod. No.: 001 Rx (1.7-20 X 10^6CELL/ML)

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Aug 17, 2029	New exclusivity for this product

Zynyz (Injection) (Intravenous) retifanlimab-dlwr
NDA Applicant: Incyte Corporation      BLA No.: 761334  Prod. No.: 001 Rx (500MG/20ML (25MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: Orphan Drug Exclusivity	Mar 22, 2030	New product in Purple Book