AQVESME / PYRUKYND — FDA application NDA216196
Listed sponsor: AGIOS PHARMS INC · AGIO company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10632114 | 001 | listed patent expiry date: 2032-05-03 | U-3320 |
| Patent 10632114 | 002 | listed patent expiry date: 2032-05-03 | U-3320 |
| Patent 10632114 | 003 | listed patent expiry date: 2032-05-03 | U-3320 |
| Patent 10632114 | 004 | listed patent expiry date: 2032-05-03 | U-4391 |
| Patent 9682080 | 001 | listed patent expiry date: 2032-05-03 | U-3319 |
| Patent 9682080 | 002 | listed patent expiry date: 2032-05-03 | U-3319 |
| Patent 9682080 | 003 | listed patent expiry date: 2032-05-03 | U-3319 |
| Patent 9682080 | 004 | listed patent expiry date: 2032-05-03 | U-4392 |
| Patent 9980961 | 001 | listed patent expiry date: 2032-05-03 | U-3319 |
| Patent 9980961 | 002 | listed patent expiry date: 2032-05-03 | U-3319 |
| Patent 9980961 | 003 | listed patent expiry date: 2032-05-03 | U-3319 |
| Patent 9193701 | 001 | listed patent expiry date: 2032-10-26 | U-3319 |
| Patent 9193701 | 002 | listed patent expiry date: 2032-10-26 | U-3319 |
| Patent 9193701 | 003 | listed patent expiry date: 2032-10-26 | U-3319 |
| Patent 9193701 | 004 | listed patent expiry date: 2032-10-26 | U-4393 |
| Patent 11793806 | 001 | listed patent expiry date: 2033-04-12 | U-3320 |
| Patent 11793806 | 002 | listed patent expiry date: 2033-04-12 | U-3320 |
| Patent 11793806 | 003 | listed patent expiry date: 2033-04-12 | U-3320 |
| Patent RE49582 | 001 | listed patent expiry date: 2035-04-11 | drug substance, drug product |
| Patent RE49582 | 002 | listed patent expiry date: 2035-04-11 | drug substance, drug product |
| Patent RE49582 | 003 | listed patent expiry date: 2035-04-11 | drug substance, drug product |
| Patent RE49582 | 004 | listed patent expiry date: 2035-04-11 | drug substance, drug product |
| Patent 11234976 | 001 | listed patent expiry date: 2038-10-11 | U-3321 |
| Patent 11234976 | 002 | listed patent expiry date: 2038-10-11 | U-3321 |
| Patent 11234976 | 003 | listed patent expiry date: 2038-10-11 | U-3321 |
| Patent 11254652 | 001 | listed patent expiry date: 2038-11-21 | drug substance, drug product |
| Patent 11254652 | 002 | listed patent expiry date: 2038-11-21 | drug substance, drug product |
| Patent 11254652 | 003 | listed patent expiry date: 2038-11-21 | drug substance, drug product |
| Patent 11254652 | 004 | listed patent expiry date: 2038-11-21 | drug substance, drug product |
| Patent 11878049 | 001 | listed patent expiry date: 2041-07-31 | U-3782 |
| Patent 11878049 | 002 | listed patent expiry date: 2041-07-31 | U-3782 |
| Patent 11878049 | 003 | listed patent expiry date: 2041-07-31 | U-3782 |
| Patent 11878049 | 004 | listed patent expiry date: 2041-07-31 | U-4390 |
| Exclusivity NCE | 001 | listed exclusivity date: 2027-02-17 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2027-02-17 | FDA code as listed |
| Exclusivity NCE | 003 | listed exclusivity date: 2027-02-17 | FDA code as listed |
| Exclusivity NCE | 004 | listed exclusivity date: 2027-02-17 | FDA code as listed |
| Exclusivity NP | 004 | listed exclusivity date: 2028-12-23 | FDA code as listed |
| Exclusivity ODE-392 | 001 | listed exclusivity date: 2029-02-17 | FDA code as listed |
| Exclusivity ODE-392 | 002 | listed exclusivity date: 2029-02-17 | FDA code as listed |
| Exclusivity ODE-392 | 003 | listed exclusivity date: 2029-02-17 | FDA code as listed |
| Exclusivity ODE-522 | 004 | listed exclusivity date: 2032-12-23 | FDA code as listed |
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 · CHEMBL4299940
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.