AQVESME Drug Patent Profile
When do Aqvesme patents expire, and what generic alternatives are available?
Aqvesme is a drug marketed by Agios Pharms Inc and is included in one NDA. There are six patents protecting this drug.
The generic ingredient in AQVESME is mitapivat sulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mitapivat sulfate profile page.
DrugPatentWatch® Generic Entry Outlook for Aqvesme
Aqvesme was eligible for patent challenges on February 17, 2026.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for AQVESME?
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Summary for AQVESME
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| What excipients (inactive ingredients) are in AQVESME? | AQVESME excipients list |
| DailyMed Link: | AQVESME at DailyMed |
US Patents and Regulatory Information for AQVESME
AQVESME is protected by six US patents and three FDA Regulatory Exclusivities.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Agios Pharms Inc | AQVESME | mitapivat sulfate | TABLET;ORAL | 216196-004 | Dec 23, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Agios Pharms Inc | AQVESME | mitapivat sulfate | TABLET;ORAL | 216196-004 | Dec 23, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Agios Pharms Inc | AQVESME | mitapivat sulfate | TABLET;ORAL | 216196-004 | Dec 23, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Agios Pharms Inc | AQVESME | mitapivat sulfate | TABLET;ORAL | 216196-004 | Dec 23, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Agios Pharms Inc | AQVESME | mitapivat sulfate | TABLET;ORAL | 216196-004 | Dec 23, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Agios Pharms Inc | AQVESME | mitapivat sulfate | TABLET;ORAL | 216196-004 | Dec 23, 2025 | RX | Yes | Yes | ⤷ 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 |
International Patents for AQVESME
See the table below for patents covering AQVESME around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2012250688 | ⤷ Start Trial | |
| Australia | 2017221860 | ⤷ Start Trial | |
| Australia | 2020200700 | ⤷ Start Trial | |
| Brazil | 112013028422 | ⤷ Start Trial | |
| Canada | 2834602 | ⤷ Start Trial | |
| Canada | 3088328 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AQVESME
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2448582 | 301230 | Netherlands | ⤷ Start Trial | PRODUCT NAME: MITAPIVAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER MITAPIVATSULFAAT; REGISTRATION NO/DATE: EU/1/22/1662 20221110 |
| 2448582 | CA 2023 00014 | Denmark | ⤷ Start Trial | PRODUCT NAME: MITAPIVAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MITAPIVATSULFAT; REG. NO/DATE: EU/1/22/1662 20221110 |
| 2448582 | 2023C/517 | Belgium | ⤷ Start Trial | PRODUCT NAME: MITAPIVAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE SULFATE DE MITAPIVAT; AUTHORISATION NUMBER AND DATE: EU/1/22/1662 20221110 |
| 2448582 | LUC00306 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: MITAPIVAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MITAPIVAT SULFATE; AUTHORISATION NUMBER AND DATE: EU/1/22/1662 20221110 |
| 2448582 | PA2023513 | Lithuania | ⤷ Start Trial | PRODUCT NAME: MITAPIVATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC MITAPIVATO SULFATAS; REGISTRATION NO/DATE: EU/1/22/1662 20221109 |
| 2448582 | CR 2023 00014 | Denmark | ⤷ Start Trial | PRODUCT NAME: MITAPIVAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MITAPIVATSULFAT; REG. NO/DATE: EU/1/22/1662 20221110 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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