SAPROPTERIN Drug Patent Profile
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When do Sapropterin patents expire, and when can generic versions of Sapropterin launch?
Sapropterin is a drug marketed by Annora Pharma, Dr Reddys, and Endo Operations. and is included in eight NDAs.
The generic ingredient in SAPROPTERIN is sapropterin dihydrochloride. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sapropterin
A generic version of SAPROPTERIN was approved as sapropterin dihydrochloride by ENDO OPERATIONS on May 10th, 2019.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SAPROPTERIN?
- What are the global sales for SAPROPTERIN?
- What is Average Wholesale Price for SAPROPTERIN?
Summary for SAPROPTERIN
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 8 |
| Drug Prices: | Drug price information for SAPROPTERIN |
| DailyMed Link: | SAPROPTERIN at DailyMed |
US Patents and Regulatory Information for SAPROPTERIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Annora Pharma | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215420-001 | Aug 18, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Annora Pharma | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 215534-001 | Aug 23, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215798-001 | May 13, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 207685-001 | Jun 15, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
