QULIPTA — FDA application NDA215206
Listed sponsor: ABBVIE · ABBV 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 | QULIPTA | ATOGEPANT | TABLET | ORAL | 10MG | Prescription | not listed | Yes |
| 002 | QULIPTA | ATOGEPANT | TABLET | ORAL | 30MG | Prescription | not listed | Yes |
| 003 | QULIPTA | ATOGEPANT | TABLET | ORAL | 60MG | 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 9499545 | 001 | listed patent expiry date: 2031-11-10 | drug substance, drug product, U-3534 |
| Patent 9499545 | 002 | listed patent expiry date: 2031-11-10 | drug substance, drug product, U-3534 |
| Patent 9499545 | 003 | listed patent expiry date: 2031-11-10 | drug substance, drug product, U-3534 |
| Patent 9850246 | 001 | listed patent expiry date: 2033-03-13 | drug substance |
| Patent 9850246 | 002 | listed patent expiry date: 2033-03-13 | drug substance |
| Patent 9850246 | 003 | listed patent expiry date: 2033-03-13 | drug substance |
| Patent 10117836 | 001 | listed patent expiry date: 2035-01-30 | drug product |
| Patent 10117836 | 002 | listed patent expiry date: 2035-01-30 | drug product |
| Patent 10117836 | 003 | listed patent expiry date: 2035-01-30 | drug product |
| Patent 8754096 | 001 | listed patent expiry date: 2035-09-28 | drug substance, drug product, U-3534 |
| Patent 8754096 | 002 | listed patent expiry date: 2035-09-28 | drug substance, drug product, U-3534 |
| Patent 8754096 | 003 | listed patent expiry date: 2035-09-28 | drug substance, drug product, U-3534 |
| Patent 12383545 | 001 | listed patent expiry date: 2039-06-06 | U-3534 |
| Patent 12383545 | 002 | listed patent expiry date: 2039-06-06 | U-3534 |
| Patent 12383545 | 003 | listed patent expiry date: 2039-06-06 | U-3534 |
| Patent 12090148 | 001 | listed patent expiry date: 2041-07-29 | U-3534 |
| Patent 12090148 | 002 | listed patent expiry date: 2041-07-29 | U-3534 |
| Patent 12090148 | 003 | listed patent expiry date: 2041-07-29 | U-3534 |
| Patent 12465598 | 001 | listed patent expiry date: 2042-09-27 | U-4355 |
| Patent 12622897 | 001 | listed patent expiry date: 2042-09-27 | U-4536 |
| Patent 12622897 | 002 | listed patent expiry date: 2042-09-27 | U-4536 |
| Patent 12350259 | 001 | listed patent expiry date: 2043-02-27 | U-4234 |
| Exclusivity I-909 | 001 | listed exclusivity date: 2026-04-17 | FDA code as listed |
| Exclusivity I-909 | 002 | listed exclusivity date: 2026-04-17 | FDA code as listed |
| Exclusivity I-909 | 003 | listed exclusivity date: 2026-04-17 | FDA code as listed |
| Exclusivity NCE | 001 | listed exclusivity date: 2026-09-28 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2026-09-28 | FDA code as listed |
| Exclusivity NCE | 003 | listed exclusivity date: 2026-09-28 | 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
- ATOGEPANT · UNII 7CRV8RR151 · lmmol compound QIVUCLWGARAQIO-OLIXTKCUSA-N · CHEMBL3991065
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: Large-cap biopharma
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.