# AQVESME / PYRUKYND — FDA application NDA216196

Informational only - not investment advice.

Application NDA216196 · type NDA · FDA status: approved · original approval 2022-02-17

Listed sponsor: AGIOS PHARMS INC · [AGIO company profile](/company/AGIO/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | PYRUKYND | MITAPIVAT SULFATE | TABLET | ORAL | EQ 5MG BASE | Prescription | not listed | Yes |
| 002 | PYRUKYND | MITAPIVAT SULFATE | TABLET | ORAL | EQ 20MG BASE | Prescription | not listed | Yes |
| 003 | PYRUKYND | MITAPIVAT SULFATE | TABLET | ORAL | EQ 50MG BASE | Prescription | not listed | Yes |
| 004 | AQVESME | MITAPIVAT SULFATE | TABLET | ORAL | EQ 100MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10632114, product 001; listed patent expiry date: 2032-05-03.
- Patent 10632114, product 002; listed patent expiry date: 2032-05-03.
- Patent 10632114, product 003; listed patent expiry date: 2032-05-03.
- Patent 10632114, product 004; listed patent expiry date: 2032-05-03.
- Patent 9682080, product 001; listed patent expiry date: 2032-05-03.
- Patent 9682080, product 002; listed patent expiry date: 2032-05-03.
- Patent 9682080, product 003; listed patent expiry date: 2032-05-03.
- Patent 9682080, product 004; listed patent expiry date: 2032-05-03.
- Patent 9980961, product 001; listed patent expiry date: 2032-05-03.
- Patent 9980961, product 002; listed patent expiry date: 2032-05-03.
- Patent 9980961, product 003; listed patent expiry date: 2032-05-03.
- Patent 9193701, product 001; listed patent expiry date: 2032-10-26.
- Patent 9193701, product 002; listed patent expiry date: 2032-10-26.
- Patent 9193701, product 003; listed patent expiry date: 2032-10-26.
- Patent 9193701, product 004; listed patent expiry date: 2032-10-26.
- Patent 11793806, product 001; listed patent expiry date: 2033-04-12.
- Patent 11793806, product 002; listed patent expiry date: 2033-04-12.
- Patent 11793806, product 003; listed patent expiry date: 2033-04-12.
- Patent RE49582, product 001; listed patent expiry date: 2035-04-11.
- Patent RE49582, product 002; listed patent expiry date: 2035-04-11.
- Patent RE49582, product 003; listed patent expiry date: 2035-04-11.
- Patent RE49582, product 004; listed patent expiry date: 2035-04-11.
- Patent 11234976, product 001; listed patent expiry date: 2038-10-11.
- Patent 11234976, product 002; listed patent expiry date: 2038-10-11.
- Patent 11234976, product 003; listed patent expiry date: 2038-10-11.
- Patent 11254652, product 001; listed patent expiry date: 2038-11-21.
- Patent 11254652, product 002; listed patent expiry date: 2038-11-21.
- Patent 11254652, product 003; listed patent expiry date: 2038-11-21.
- Patent 11254652, product 004; listed patent expiry date: 2038-11-21.
- Patent 11878049, product 001; listed patent expiry date: 2041-07-31.
- Patent 11878049, product 002; listed patent expiry date: 2041-07-31.
- Patent 11878049, product 003; listed patent expiry date: 2041-07-31.
- Patent 11878049, product 004; listed patent expiry date: 2041-07-31.
- Exclusivity NCE, product 001; listed exclusivity date: 2027-02-17.
- Exclusivity NCE, product 002; listed exclusivity date: 2027-02-17.
- Exclusivity NCE, product 003; listed exclusivity date: 2027-02-17.
- Exclusivity NCE, product 004; listed exclusivity date: 2027-02-17.
- Exclusivity NP, product 004; listed exclusivity date: 2028-12-23.
- Exclusivity ODE-392, product 001; listed exclusivity date: 2029-02-17.
- Exclusivity ODE-392, product 002; listed exclusivity date: 2029-02-17.
- Exclusivity ODE-392, product 003; listed exclusivity date: 2029-02-17.
- Exclusivity ODE-522, product 004; listed exclusivity date: 2032-12-23.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- MITAPIVAT · UNII 2WTV10SIKH · [lmmol compound XAYGBKHKBBXDAK-UHFFFAOYSA-N](https://lmmol.com/compound/XAYGBKHKBBXDAK-UHFFFAOYSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/AGIO/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA216196. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.