List of Kuvan drug patents

Kuvan is owned by Biomarin Pharm.

Kuvan contains Sapropterin Dihydrochloride.

Kuvan has a total of 20 drug patents out of which 0 drug patents have expired.

Kuvan was authorised for market use on 19 December, 2013.

Kuvan is available in powder;oral dosage forms.

Kuvan can be used as to reduce blood phenylalanine (phe) levels in patients with hyperphenylalaninemia (hpa), for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia, 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.

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

KUVAN's oppositions filed in EPO
Patent Number Company Patent Title Patent Expiry Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8067416 BIOMARIN PHARM Methods and compositions for the treatment of metabolic disorders
Nov, 2024

(1 year, 7 months from now)

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

(1 year, 7 months from now)

USRE43797 BIOMARIN PHARM Methods of administering tetrahydrobiopterin
Nov, 2024

(1 year, 7 months from now)

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

(1 year, 7 months from now)

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

(1 year, 7 months from now)

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

(1 year, 7 months from now)

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

(1 year, 7 months from now)

US8067416

(Pediatric)

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

(2 years from now)

US7612073

(Pediatric)

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

(2 years from now)

US7727987

(Pediatric)

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

(2 years from now)

USRE43797

(Pediatric)

BIOMARIN PHARM Methods of administering tetrahydrobiopterin
May, 2025

(2 years from now)

US7566714

(Pediatric)

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

(2 years from now)

US8318745

(Pediatric)

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

(2 years from now)

US9433624

(Pediatric)

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

(2 years from now)

US7566462 BIOMARIN PHARM Stable tablet formulation
Nov, 2025

(2 years from now)

US8003126 BIOMARIN PHARM Stable tablet formulation
Nov, 2025

(2 years from now)

US7566462

(Pediatric)

BIOMARIN PHARM Stable tablet formulation
May, 2026

(3 years from now)

US8003126

(Pediatric)

BIOMARIN PHARM Stable tablet formulation
May, 2026

(3 years from now)

US9216178 BIOMARIN PHARM Dry blend formulation of tetrahydrobiopterin
Nov, 2032

(9 years from now)

US9216178

(Pediatric)

BIOMARIN PHARM Dry blend formulation of tetrahydrobiopterin
May, 2033

(10 years from now)

Drugs and Companies using SAPROPTERIN DIHYDROCHLORIDE ingredient

Market Authorisation Date: 19 December, 2013

Treatment: For reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia; To reduce blood phenylalanine (phe) levels in patients with hyperphenylalaninemia (hpa); 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

Dosage: POWDER;ORAL

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

KUVAN family patents

38

United States

11

European Union

9

Japan

8

Canada

7

Spain

7

Korea, Republic of

6

Australia

5

Portugal

5

China

5

Poland

5

Denmark

4

Brazil

4

Mexico

4

Slovenia

4

Hungary

3

Russia

3

Croatia

3

Hong Kong

3

Israel

2

Lithuania

2

Cyprus

1

Germany

1

Malaysia

1

IB

1

Argentina

1

Peru

1

Taiwan, Province of China

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