ZELVYSIA Drug Patent Profile
Which patents cover Zelvysia, and when can generic versions of Zelvysia launch?
Zelvysia is a drug marketed by Aucta and is included in one NDA.
The generic ingredient in ZELVYSIA is sapropterin dihydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zelvysia
A generic version of ZELVYSIA was approved as sapropterin dihydrochloride by PH HEALTH on May 10th, 2019.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for ZELVYSIA?
- What are the global sales for ZELVYSIA?
- What is Average Wholesale Price for ZELVYSIA?
Summary for ZELVYSIA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | ZELVYSIA at DailyMed |
US Patents and Regulatory Information for ZELVYSIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aucta | ZELVYSIA | sapropterin dihydrochloride | FOR SOLUTION;ORAL | 218645-001 | Apr 29, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aucta | ZELVYSIA | sapropterin dihydrochloride | FOR SOLUTION;ORAL | 218645-002 | Apr 29, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
