Pharsight

Kuvan patents expiration

KUVAN's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7947681 BIOMARIN PHARM Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Nov, 2024

(6 months from now)

USRE43797 BIOMARIN PHARM Methods of administering tetrahydrobiopterin
Nov, 2024

(6 months from now)

US7612073 BIOMARIN PHARM Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Nov, 2024

(6 months from now)

US7566714 BIOMARIN PHARM Methods and compositions for the treatment of metabolic disorders
Nov, 2024

(6 months from now)

US8067416 BIOMARIN PHARM Methods and compositions for the treatment of metabolic disorders
Nov, 2024

(6 months from now)

US9433624 BIOMARIN PHARM Methods and compositions for the treatment of metabolic disorders
Nov, 2024

(6 months from now)

US7727987 BIOMARIN PHARM Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
Nov, 2024

(6 months from now)

US8318745 BIOMARIN PHARM Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
Nov, 2024

(6 months from now)

USRE43797

(Pediatric)

BIOMARIN PHARM Methods of administering tetrahydrobiopterin
May, 2025

(1 year, 23 days from now)

US7947681

(Pediatric)

BIOMARIN PHARM Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
May, 2025

(1 year, 23 days from now)

US7566714

(Pediatric)

BIOMARIN PHARM Methods and compositions for the treatment of metabolic disorders
May, 2025

(1 year, 23 days from now)

US7612073

(Pediatric)

BIOMARIN PHARM Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
May, 2025

(1 year, 23 days from now)

US7727987

(Pediatric)

BIOMARIN PHARM Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
May, 2025

(1 year, 23 days from now)

US8067416

(Pediatric)

BIOMARIN PHARM Methods and compositions for the treatment of metabolic disorders
May, 2025

(1 year, 23 days from now)

US9433624

(Pediatric)

BIOMARIN PHARM Methods and compositions for the treatment of metabolic disorders
May, 2025

(1 year, 23 days from now)

US8318745

(Pediatric)

BIOMARIN PHARM Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
May, 2025

(1 year, 23 days from now)

US7566462 BIOMARIN PHARM Stable tablet formulation
Nov, 2025

(1 year, 6 months from now)

US8003126 BIOMARIN PHARM Stable tablet formulation
Nov, 2025

(1 year, 6 months from now)

US8003126

(Pediatric)

BIOMARIN PHARM Stable tablet formulation
May, 2026

(2 years from now)

US7566462

(Pediatric)

BIOMARIN PHARM Stable tablet formulation
May, 2026

(2 years from now)

US9216178 BIOMARIN PHARM Dry blend formulation of tetrahydrobiopterin
Nov, 2032

(8 years from now)

US9216178

(Pediatric)

BIOMARIN PHARM Dry blend formulation of tetrahydrobiopterin
May, 2033

(9 years from now)

Kuvan is owned by Biomarin Pharm.

Kuvan contains Sapropterin Dihydrochloride.

Kuvan has a total of 22 drug patents out of which 0 drug patents have expired.

Kuvan was authorised for market use on 13 December, 2007.

Kuvan is available in powder;oral, tablet;oral dosage forms.

Kuvan can be used as method of use for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia, to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetra hydrobiopterin responsive phenylketonuria. kuvan should be taken orally with food to increase absorption, kuvan is indicated to reduce blood phenylalanine levels in patients with hyperphenylalaninemia, to reduce blood phenylalanine (phe) levels in patients with hyperphenylalaninemia (hpa).

Drug patent challenges can be filed against Kuvan from 23 October, 2016.

The generics of Kuvan are possible to be released after 01 May, 2033.

Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Apr 23, 2017
Pediatric Exclusivity(PED) Oct 23, 2017
Orphan Drug Exclusivity(ODE) Dec 13, 2014
New Chemical Entity Exclusivity(NCE) Dec 13, 2012

Drugs and Companies using SAPROPTERIN DIHYDROCHLORIDE ingredient

NCE-1 date: 23 October, 2016

Market Authorisation Date: 13 December, 2007

Treatment: To reduce blood phenylalanine (phe) levels in patients with hyperphenylalaninemia (hpa); Kuvan is indicated to reduce blood phenylalanine levels in patients with hyperphenylalaninemia; To reduce blood...

Dosage: TABLET;ORAL; POWDER;ORAL

How can I launch a generic of KUVAN before it's drug patent expiration?
More Information on Dosage

KUVAN family patents

Family Patents