Amino Acid Metabolism Disorders Therapeutics

1. Kuvan patent expiration

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

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).
USRE43797 BIOMARIN Methods of administering tetrahydrobiopterin
Nov, 2024

(1 year, 3 months ago)

US7947681

(Pediatric)

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

(9 months ago)

US7947681 BIOMARIN Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Nov, 2024

(1 year, 3 months ago)

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

(1 year, 3 months ago)

US9433624

(Pediatric)

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

(9 months ago)

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

(1 year, 3 months ago)

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

(1 year, 3 months ago)

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

(1 year, 3 months ago)

US8003126 BIOMARIN Stable tablet formulation
Nov, 2025

(3 months ago)

US7566462 BIOMARIN Stable tablet formulation
Nov, 2025

(3 months ago)

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

(1 year, 3 months ago)

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

(1 year, 3 months ago)

US9216178 BIOMARIN Dry blend formulation of tetrahydrobiopterin
Nov, 2032

(6 years from now)

US7566462

(Pediatric)

BIOMARIN Stable tablet formulation
May, 2026

(2 months from now)

US7566714

(Pediatric)

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

(9 months ago)

US7612073

(Pediatric)

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

(9 months ago)

US7727987

(Pediatric)

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

(9 months ago)

US8003126

(Pediatric)

BIOMARIN Stable tablet formulation
May, 2026

(2 months from now)

US8067416

(Pediatric)

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

(9 months ago)

US8318745

(Pediatric)

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

(9 months ago)

USRE43797

(Pediatric)

BIOMARIN Methods of administering tetrahydrobiopterin
May, 2025

(9 months ago)

US9216178

(Pediatric)

BIOMARIN Dry blend formulation of tetrahydrobiopterin
May, 2033

(7 years from now)




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

Drugs and Companies using SAPROPTERIN DIHYDROCHLORIDE ingredient

NCE-1 date: 23 October, 2016

Market Authorisation Date: 13 December, 2007

Dosage: TABLET; POWDER

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

KUVAN family patents

Family Patents