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
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 | Biomarin Pharm |
| Kuvan |
US7612073 (Pediatric) | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring | May 17, 2025 | Biomarin Pharm |
| Kuvan |
US7727987 (Pediatric) | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride | May 17, 2025 | Biomarin Pharm |
| Kuvan |
US7947681 (Pediatric) | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring | May 17, 2025 | Biomarin Pharm |
| Kuvan |
US8067416 (Pediatric) | Methods and compositions for the treatment of metabolic disorders | May 17, 2025 | Biomarin Pharm |
| Kuvan |
US8318745 (Pediatric) | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride | May 17, 2025 | Biomarin Pharm |
| Kuvan |
US9433624 (Pediatric) | Methods and compositions for the treatment of metabolic disorders | May 17, 2025 | Biomarin Pharm |
| Kuvan |
USRE43797 (Pediatric) | Methods of administering tetrahydrobiopterin | May 17, 2025 | Biomarin Pharm |
| Kuvan | US7566714 | Methods and compositions for the treatment of metabolic disorders | Nov 17, 2024 | Biomarin Pharm |
| Kuvan | US7612073 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring | Nov 17, 2024 | Biomarin Pharm |
| Kuvan | US7727987 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride | Nov 17, 2024 | Biomarin Pharm |
| Kuvan | US7947681 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring | Nov 17, 2024 | Biomarin Pharm |
| Kuvan | US8067416 | Methods and compositions for the treatment of metabolic disorders | Nov 17, 2024 | Biomarin Pharm |
| Kuvan | US8318745 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride | Nov 17, 2024 | Biomarin Pharm |
| Kuvan | US9433624 | Methods and compositions for the treatment of metabolic disorders | Nov 17, 2024 | Biomarin Pharm |
| Kuvan | USRE43797 | Methods of administering tetrahydrobiopterin | Nov 17, 2024 | Biomarin Pharm |
Sapropterin Dihydrochloride's 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 Endo Operations Ltd and was approved on May 10, 2019. And the latest generic version is by Annora Pharma Private Ltd and was approved on Aug 23, 2022.
Given below is the list of companies who have filed for Sapropterin Dihydrochloride generic, along with the locations of their manufacturing plants worldwide.
1. ANNORA PHARMA
Annora Pharma Private Ltd has filed for 3 different strengths of generic version for Sapropterin Dihydrochloride. Given below are the details of the strengths of this generic introduced by Annora Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG/PACKET | powder | Prescription | ORAL | AB | Aug 18, 2022 |
| 500MG/PACKET | powder | Prescription | ORAL | AB | Aug 18, 2022 |
| 100MG | tablet | Prescription | ORAL | AB | Aug 23, 2022 |
Manufacturing Plant Locations New
Annora Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Annora Pharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
2. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 3 different strengths of generic version for Sapropterin Dihydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG/PACKET | powder | Prescription | ORAL | AB | Mar 30, 2021 |
| 100MG | tablet | Prescription | ORAL | AB | Jun 15, 2021 |
| 500MG/PACKET | powder | Prescription | ORAL | AB | May 13, 2022 |
3. ENDO OPERATIONS
Endo Operations Ltd has filed for 3 different strengths of generic version for Sapropterin Dihydrochloride. Given below are the details of the strengths of this generic introduced by Endo Operations.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG | tablet | Prescription | ORAL | AB | May 10, 2019 |
| 100MG/PACKET | powder | Prescription | ORAL | AB | Aug 20, 2019 |
| 500MG/PACKET | powder | Prescription | ORAL | AB | Aug 20, 2019 |