Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 22, 2024 | Orphan Designation: Prevention and/or treatment of acute attacks of hereditary angioedema. Approved Labeled Indication: For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. Exclusivity Protected Indication: For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. |
Helixate Fs, Kogenate, Kogenate Fs (For Injection) (Intravenous) Antihemophilic Factor (Recombinant)
NDA Applicant: Bayer HealthCare LLC BLA No.: 103332 Prod. No.: 001 Rx (250IU); 002 Rx (500IU); 003 Rx (1000IU); 004 Rx (2000IU); 005 Rx (3000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 25, 2000 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Hemgenix (Injection) (Intravenous) etranacogene dezaparvovec-drlb
NDA Applicant: CSL Behring LLC BLA No.: 125772 Prod. No.: 001 Rx (1X10E13GENOME COPIES/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 22, 2029 | Orphan Designation: Treatment of Hemophilia B Approved Labeled Indication: Treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: currently use Factor IX prophylaxis therapy, or; have current or historical life-threatening hemorrhage, or; have repeated, serious spontaneous bleeding episodes Exclusivity Protected Indication: Treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: currently use Factor IX prophylaxis therapy, or; have current or historical life-threatening hemorrhage, or; have repeated, serious spontaneous bleeding episodes |
| Exclusivity Type: Ref. Product Exclusivity | Nov 22, 2034 |
Hemlibra (Injection) (Subcutaneous) emicizumab-kxwh
NDA Applicant: Genentech, Inc. BLA No.: 761083 Prod. No.: 001 Rx (30MG/ML); 002 Rx (60MG/0.4ML); 003 Rx (105MG/0.7ML); 004 Rx (150MG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 16, 2024 | Orphan Designation: Treatment of hemophilia A Approved Labeled Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors Exclusivity Protected Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 4, 2025 | Orphan Designation: Treatment of hemophilia A Approved Labeled Indication: HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. Exclusivity Protected Indication: HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors. |
Hepagam B (Injection) (Intramuscular) Hepatitis B Immune Globulin (Human)
NDA Applicant: Kamada Ltd. BLA No.: 125035 Prod. No.: 001 Rx (>1560IU/5ML); 002 Rx (>312IU/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 6, 2014 | Orphan Designation: Prevention of hepatitis B recurrence following orthotopic liver transplant Approved Labeled Indication: Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients |
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 | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 6, 2014 | Orphan Designation: Prevention of hepatitis B recurrence following orthotopic liver transplant Approved Labeled Indication: Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients |
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 | Patented Use |
|---|---|---|
| Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Pat. No. 10662237 Method to improve virus filtration capacity Claim Types: Process Pat. Sub. Date(s): None | May 26, 2030 | |
| Pat. No. 10808037 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 20, 2017 | Orphan Designation: Treatment of HER2-overexpressing advanced adenocarcinoma of the stomach, including gastroesophageal junction Approved Labeled Indication: Treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease |
Hizentra (Injection) (Subcutaneous) Immune Globulin Subcutaneous (Human), 20% Liquid
NDA Applicant: CSL Behring AG BLA No.: 125350 Prod. No.: 001 Rx (2G); 002 Rx (1G); 003 Rx (10G); 004 Rx (4G)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 15, 2025 | Orphan Designation: Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) Approved Labeled Indication: Indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. Exclusivity Protected Indication: Indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment |
Humate-P (For Injection) (Intravenous) Antihemophilic Factor/von Willebrand Factor Complex (Human)
NDA Applicant: CSL Behring GmbH BLA No.: 103960 Prod. No.: 001 Rx (1000IU); 002 Rx (250IU); 003 Rx (500IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2006 | Orphan Designation: Treatment of patients with von Willebrand's disease Approved Labeled Indication: (1) In adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia) and (2) in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate. |
Humatrope (For Injection) (Subcutaneous) somatropin
NDA Applicant: Eli Lilly and Company BLA No.: 019640 Prod. No.: 005 Rx (6MG); 006 Rx (12MG); 007 Rx (24MG) BLA No.: 019640 Prod. No.: 001 Disc (2MG); 004 Disc (5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 8, 1994 | Orphan Designation: For the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 30, 2003 | Orphan Designation: Treatment of short stature associated with Turner syndrome. Approved Labeled Indication: Treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed. |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 1, 2013 | Orphan Designation: Treatment of short stature in pediatric patients with short stature homeobox-containing gene (SHOX) deficiency Approved Labeled Indication: Treatment of short stature or growth failure in children with SHOX (short stature homeobox-containing gene) deficiency whose epiphyses are not closed |
Humira (Injection) (Subcutaneous) adalimumab
NDA Applicant: AbbVie Inc. BLA No.: 125057 Prod. No.: 001 Rx (40MG/0.8ML); 002 Rx (40MG/0.8ML); 004 Rx (40MG/0.8ML); 006 Rx (40MG/0.4ML); 007 Rx (40MG/0.4ML); 008 Rx (80MG/0.8ML); 009 Rx (80MG/0.8ML); 010 Rx (20MG/0.2ML); 011 Rx (10MG/0.1ML) BLA No.: 125057 Prod. No.: 003 Disc (20MG/0.4ML); 005 Disc (10MG/0.2ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6805686 Autoinjector with extendable needle protector shroud Claim Types: Device; Method of administration Pat. Sub. Date(s): None | May 6, 2023 | |
| Pat. No. 8231876 Purified antibody composition Claim Types: Product-by-process; Drug in a container Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 8420081 Antibody formulations and methods of making same Claim Types: Formulation; Product-by-process; Device; Drug in a container; Process Pat. Sub. Date(s): None | Jan 13, 2030 | |
| Pat. No. 8663945 Methods of producing anti-TNF-alpha antibodies in mammalian cell culture Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 8708968 Removal of needle shields from syringes and automatic injection devices Claim Types: Device Pat. Sub. Date(s): None | Jan 24, 2032 | |
| Pat. No. 8715664 Use of human TNF.alpha. antibodies for treatment of erosive polyarthritis Claim Types: Method of use Pat. Sub. Date(s): None | Jul 24, 2027 | |
| Pat. No. 8808700 Use of TNF alpha inhibitor for treatment of erosive polyarthritis Claim Types: Method of use Pat. Sub. Date(s): None | May 16, 2026 | |
| Pat. No. 8883156 Purified antibody composition Claim Types: Method of use Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 8889136 Multiple-variable dose regimen for treating TNF.alpha.-related disorders Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Oct 9, 2027 | |
| Pat. No. 8895009 Purified antibody composition Claim Types: Formulation Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 8906372 Purified antibody composition Claim Types: Method of use Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 8906373 Use of TNF-alpha inhibitor for treatment of psoriasis Claim Types: Method of use Pat. Sub. Date(s): None | Jul 18, 2023 | |
| Pat. No. 8906646 Fed-batch method of making human anti-TNF-alpha antibody Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 8911737 Methods of administering anti-TNF.alpha. antibodies Claim Types: Method of use Pat. Sub. Date(s): None | Jun 5, 2022 | |
| Pat. No. 8911964 Fed-batch method of making human anti-TNF-alpha antibody Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 8916153 Purified antibody composition Claim Types: Composition Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 8926975 Method of treating ankylosing spondylitis Claim Types: Method of use Pat. Sub. Date(s): None | Jun 8, 2027 | |
| Pat. No. 8961973 Multiple-variable dose regimen for treating TNF.alpha.-related disorders Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 8961974 Multiple-variable dose regimen for treating TNF.alpha.-related disorders Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 8974790 Methods of administering anti-TNF.alpha. antibodies Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Jun 5, 2022 | |
| Pat. No. 8986693 Use of TNF.alpha. inhibitor for treatment of psoriasis Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 8992926 Methods of administering anti-TNF.alpha. antibodies Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Jun 5, 2022 | |
| Pat. No. 8999337 Methods for treating juvenile idiopathic arthritis by inhibition of TNF.alpha. Claim Types: Method of use Pat. Sub. Date(s): None | Feb 6, 2031 | |
| Pat. No. 9061005 Multiple-variable dose regimen for treating idiopathic inflammatory bowel disease Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 9062106 Methods for controlling the galactosylation profile of recombinantly-expressed proteins Claim Types: Process Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 9067992 Use of TNF.alpha. inhibitor for treatment of psoriatic arthritis Claim Types: Method of use Pat. Sub. Date(s): None | Jul 18, 2023 | |
| Pat. No. 9085618 Low acidic species compositions and methods for producing and using the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9085619 Anti-TNF antibody formulations Claim Types: Composition; Formulation Pat. Sub. Date(s): None | Nov 28, 2028 | |
| Pat. No. 9085620 Use of TNF.alpha. inhibitor for treatment of psoriatic arthritis Claim Types: Method of administration; Process Pat. Sub. Date(s): None | Jul 18, 2023 | |
| Pat. No. 9090688 Methods for controlling the galactosylation profile of recombinantly-expressed proteins Claim Types: Process Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 9090689 Use of TNF.alpha. inhibitor for treatment of psoriasis Claim Types: Method of administration; Process Pat. Sub. Date(s): None | Jul 18, 2023 | |
| Pat. No. 9090867 Fed-batch method of making anti-TNF-alpha antibody Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 9096666 Purified antibody composition Claim Types: Formulation Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 9102723 Purified antibody composition Claim Types: Process; Product-by-process; Method of use Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 9150645 Cell culture methods to reduce acidic species Claim Types: Process Pat. Sub. Date(s): None | May 13, 2033 | |
| Pat. No. 9181337 Modulated lysine variant species compositions and methods for producing and using the same Claim Types: Formulation Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9181572 Methods to modulate lysine variant distribution Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9187559 Multiple-variable dose regimen for treating idiopathic inflammatory bowel disease Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 9234032 Fed-batch methods for producing adalimumab Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 9266949 Low acidic species compositions and methods for producing and using the same Claim Types: Process Pat. Sub. Date(s): None | May 13, 2033 | |
| Pat. No. 9273132 Purified antibody composition Claim Types: Method of use Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 9284370 Methods for treating juvenile idiopathic arthritis Claim Types: Method of use Pat. Sub. Date(s): None | Jun 10, 2028 | |
| Pat. No. 9284371 Methods of producing adalimumab Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 9290568 Methods to control protein heterogeneity Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9315574 Low acidic species compositions and methods for producing and using the same Claim Types: Process Pat. Sub. Date(s): None | Apr 21, 2033 | |
| Pat. No. 9328165 Purified antibody composition Claim Types: Formulation Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 9334319 Low acidic species compositions Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9339610 Removal of needle shield from syringes and automatic injection devices Claim Types: Device Pat. Sub. Date(s): None | Jan 24, 2032 | |
| Pat. No. 9346879 Protein purification methods to reduce acidic species Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9359434 Cell culture methods to reduce acidic species Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9499614 Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 | |
| Pat. No. 9499616 Modulated lysine variant species compositions and methods for producing and using the same Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9505834 Methods for controlling the galactosylation profile of recombinantly-expressed proteins Claim Types: Process Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 9512216 Use of TNF.alpha. inhibitor Claim Types: Method of use Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 9522953 Low acidic species compositions and methods for producing and using the same Claim Types: Drug in a container; Method of use Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 9546212 Methods of administering anti-TNF.alpha. antibodies Claim Types: Method of use Pat. Sub. Date(s): None | Jun 5, 2022 | |
| Pat. No. 9550826 Glycoengineered binding protein compositions Claim Types: Formulation Pat. Sub. Date(s): None | Nov 14, 2034 | |
| Pat. No. 9624295 Uses and compositions for treatment of psoriatic arthritis Claim Types: Method of use Pat. Sub. Date(s): None | Mar 31, 2031 | |
| Pat. No. 9669093 Methods for treating juvenile idiopathic arthritis Claim Types: Method of use Pat. Sub. Date(s): None | Jun 10, 2028 | |
| Pat. No. 9683033 Cell culture methods to reduce acidic species Claim Types: Formulation; Method of use Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 9708400 Methods to modulate lysine variant distribution Claim Types: Formulation Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9913902 Purified antibody composition Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 9957318 Protein purification methods to reduce acidic species Claim Types: Process Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 11083792 Purified antibody composition Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 11167030 Protein formulations and methods of making same Claim Types: Formulation Pat. Sub. Date(s): None | Nov 28, 2028 | |
| Pat. No. 11191834 Protein formulations and methods of making same Claim Types: Formulation Pat. Sub. Date(s): None | Nov 28, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 21, 2015 | Orphan Designation: Treatment of juvenile rheumatoid arthritis Approved Labeled Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 23, 2021 | Orphan Designation: Treatment of pediatric Crohn's disease Approved Labeled Indication: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. Exclusivity Protected Indication: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 through 16 years of age with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 30, 2021 | Orphan Designation: Treatment of juvenile rheumatoid arthritis Approved Labeled Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Exclusivity Protected Indication: Treatment of polyarticular juvenile idiopathic arthritis in patients 2 to less than 4 years of age. |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 9, 2022 | Orphan Designation: Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease) Approved Labeled Indication: Treatment of moderate to severe hidradenitis suppurativa Exclusivity Protected Indication: Treatment of moderate to severe hidradenitis suppurativa |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 30, 2023 | Orphan Designation: Treatment of non-infectious intermediate, posterior, or panuveitis, or chronic non-infectious anterior uveitis Approved Labeled Indication: Indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients Exclusivity Protected Indication: Indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 28, 2025 | Orphan Designation: Treatment of non-infectious intermediate, posterior, or panuveitis, or chronic non-infectious anterior uveitis Approved Labeled Indication: Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older Exclusivity Protected Indication: Treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 16, 2025 | Orphan Designation: Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease) Approved Labeled Indication: Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. Exclusivity Protected Indication: Treatment of moderate to severe hidradenitis suppurativa (HS) in adolescent patients 12 years of age and older. |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 24, 2028 | Orphan Designation: Treatment of pediatric patients with ulcerative colitis Approved Labeled Indication: treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. Limitations of Use: The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers. Exclusivity Protected Indication: treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. Limitations of Use: The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers. |