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 | Dec 20, 2019 | Orphan Designation: Passive immunization for the treatment of exposed, susceptible individuals who are at risk of complications from varicella Approved Labeled Indication: Post exposure prophylaxis of varicella in high risk individuals to reduce the severity of varicella |
Vaxneuvance (Injection) (Intramuscular) Pneumococcal 15-valent Conjugate Vaccine
NDA Applicant: Merck Sharp & Dohme LLC BLA No.: 125741 Prod. No.: 001 Rx (2.0UG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Jul 16, 2033 |
Vimizim (Injection) (Intravenous) elosulfase alfa
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 125460 Prod. No.: 001 Rx (5MG/5ML (1MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 14, 2021 | Orphan Designation: Use in the treatment of mucopolysaccharidosis (MPS) Type IV A (Morquio A syndrome) Approved Labeled Indication: Patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) Exclusivity Protected Indication: Patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) |
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 | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 28, 2029 | Orphan Designation: Treatment of von Willebrand disease Approved Labeled Indication: For use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 VWD receiving on-demand therapy Exclusivity Protected Indication: For use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 VWD receiving on-demand therapy |
Voraxaze (For Injection) (Intravenous) glucarpidase
NDA Applicant: BTG International Inc. BLA No.: 125327 Prod. No.: 001 Rx (1,000UNITS)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 17, 2019 | Orphan Designation: Treatment of patients at risk of methotrexate toxicity Approved Labeled Indication: Treatment of toxic (>1 micromole/liter) plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function. |
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 | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 26, 2030 | Orphan Designation: Treatment of recurrent Clostridium difficile infection (CDI) Approved Labeled Indication: to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI) Exclusivity Protected Indication: to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI) |
| Exclusivity Type: Ref. Product Exclusivity | Apr 26, 2035 |
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 | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 19, 2030 | Orphan Designation: Treatment of dystrophic epidermolysis bullosa Approved Labeled Indication: treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene Exclusivity Protected Indication: treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene |
Vyvgart (Injection) (Intravenous) efgartigimod alfa-fcab
NDA Applicant: Argenx BV BLA No.: 761195 Prod. No.: 001 Rx (400MG/20ML (20MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 17, 2028 | Orphan Designation: Treatment of myasthenia gravis Approved Labeled Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive Exclusivity Protected Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive |
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 | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2030 | Orphan Designation: Treatment of myasthenia gravis Approved Labeled Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive Exclusivity Protected Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive |