Tradenames starting with "V"

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


Varizig (For Injection) (Intramuscular) Varicella Zoster Immune Globulin (Human)
NDA Applicant: Kamada Ltd.      BLA No.: 125430  Prod. No.: 002 Rx (125IU) BLA No.: 125430  Prod. No.: 001 Disc (125IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 20, 2019Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJul 16, 2033 

Vimizim (Injection) (Intravenous) elosulfase alfa
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 125460  Prod. No.: 001 Rx (5MG/5ML (1MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 14, 2021Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 28, 2029Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 17, 2019Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 26, 2030Orphan 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 ExclusivityApr 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 19, 2030Orphan 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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 17, 2028Orphan 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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 20, 2030Orphan 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



Last edited: 19 August 2023
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