Sapropterin Dihydrochloride Patent Expiration

Sapropterin Dihydrochloride is used for reducing blood phenylalanine levels in patients with hyperphenylalaninemia. It was first introduced by Biomarin Pharmaceutical Inc in its drug Kuvan on Dec 13, 2007. 7 different companies have introduced drugs containing Sapropterin Dihydrochloride.


Sapropterin Dihydrochloride Patents

Given below is the list of patents protecting Sapropterin Dihydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Kuvan US9216178

(Pediatric)

Dry blend formulation of tetrahydrobiopterin May 01, 2033 Biomarin Pharm
Kuvan US9216178 Dry blend formulation of tetrahydrobiopterin Nov 01, 2032 Biomarin Pharm
Kuvan US7566462

(Pediatric)

Stable tablet formulation May 16, 2026 Biomarin Pharm
Kuvan US8003126

(Pediatric)

Stable tablet formulation May 16, 2026 Biomarin Pharm
Kuvan US7566462 Stable tablet formulation Nov 16, 2025 Biomarin Pharm
Kuvan US8003126 Stable tablet formulation Nov 16, 2025 Biomarin Pharm
Kuvan US7566714

(Pediatric)

Methods and compositions for the treatment of metabolic disorders May 17, 2025

(Expired)

Biomarin Pharm
Kuvan US7612073

(Pediatric)

Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring May 17, 2025

(Expired)

Biomarin Pharm
Kuvan US7727987

(Pediatric)

Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride May 17, 2025

(Expired)

Biomarin Pharm
Kuvan US7947681

(Pediatric)

Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring May 17, 2025

(Expired)

Biomarin Pharm
Kuvan US8067416

(Pediatric)

Methods and compositions for the treatment of metabolic disorders May 17, 2025

(Expired)

Biomarin Pharm
Kuvan US8318745

(Pediatric)

Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride May 17, 2025

(Expired)

Biomarin Pharm
Kuvan US9433624

(Pediatric)

Methods and compositions for the treatment of metabolic disorders May 17, 2025

(Expired)

Biomarin Pharm
Kuvan USRE43797

(Pediatric)

Methods of administering tetrahydrobiopterin May 17, 2025

(Expired)

Biomarin Pharm
Kuvan US7566714 Methods and compositions for the treatment of metabolic disorders Nov 17, 2024

(Expired)

Biomarin Pharm
Kuvan US7612073 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring Nov 17, 2024

(Expired)

Biomarin Pharm
Kuvan US7727987 Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride Nov 17, 2024

(Expired)

Biomarin Pharm
Kuvan US7947681 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring Nov 17, 2024

(Expired)

Biomarin Pharm
Kuvan US8067416 Methods and compositions for the treatment of metabolic disorders Nov 17, 2024

(Expired)

Biomarin Pharm
Kuvan US8318745 Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride Nov 17, 2024

(Expired)

Biomarin Pharm
Kuvan US9433624 Methods and compositions for the treatment of metabolic disorders Nov 17, 2024

(Expired)

Biomarin Pharm
Kuvan USRE43797 Methods of administering tetrahydrobiopterin Nov 17, 2024

(Expired)

Biomarin Pharm



Sapropterin Dihydrochloride's Family Patents

Family Patents

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Sapropterin Dihydrochloride Generic API Manufacturers

Several generic applications have been filed for Sapropterin Dihydrochloride. The first generic version for Sapropterin Dihydrochloride was by Ph Health Ltd and was approved on May 10, 2019. And the latest generic version is by Zenara Pharma Private Ltd and was approved on Jun 11, 2025.

Given below is the list of companies who have filed for Sapropterin Dihydrochloride generic, along with the locations of their manufacturing plants worldwide.