Generic names starting with "V"

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

valoctocogene roxaparvovec-rvox (Injection) (Intravenous) Roctavian
NDA Applicant: Biomarin Pharmaceutical Inc.      BLA No.: 125720  Prod. No.: 001 Rx (16X 10E13GENOMES PER ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 29, 2030Orphan Designation: Treatment of Hemophilia A.
Approved Labeled Indication: treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity less than 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test
Exclusivity Protected Indication: treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity less than 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test

Varicella Zoster Immune Globulin (Human) (For Injection) (Intramuscular) Varizig
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

velmanase alfa-tycv (For Injection) (Intravenous) Lamzede
NDA Applicant: Chiesi Farmaceutici S.p.A.      BLA No.: 761278  Prod. No.: 001 Rx (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 16, 2030Orphan Designation: Treatment of alpha-mannosidosis
Approved Labeled Indication: treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients
Exclusivity Protected Indication: treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients

vestronidase alfa-vjbk (Injection) (Intravenous) Mepsevii
NDA Applicant: Ultragenyx Pharamceutical Inc.      BLA No.: 761047  Prod. No.: 001 Rx (10MG/5ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 15, 2024Orphan Designation: Treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome)
Approved Labeled Indication: Indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (PMS VII, Sly syndrome).
Exclusivity Protected Indication: Indicated in pediatric and adult patients for the treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome).

von Willebrand factor (Recombinant) (For Injection) (Intravenous) Vonvendi
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

Voretigene Neparvovec (Injection) (Intraocular) Luxturna
NDA Applicant: Spark Therapeutics, Inc.      BLA No.: 125610  Prod. No.: 001 Rx (1.5X10 TO 11 ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 19, 2024Orphan Designation: Treatment of inherited retinal dystrophy due to biallelic RPE65 gene mutations
Approved Labeled Indication: an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells determined by a treating physician
Exclusivity Protected Indication: Treatment of patients with confirmed biallelic RPE65 mutation-associated retinal distrophy. Patients must have viable retinal cells determined by a treating physician.


Last edited: 19 August 2023
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