# QULIPTA — FDA application NDA215206

Informational only - not investment advice.

Application NDA215206 · type NDA · FDA status: approved · original approval 2021-09-28

Listed sponsor: ABBVIE · [ABBV company profile](/company/ABBV/) · 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 |

## Orange Book patent and exclusivity listings

- Patent 9499545, product 001; listed patent expiry date: 2031-11-10.
- Patent 9499545, product 002; listed patent expiry date: 2031-11-10.
- Patent 9499545, product 003; listed patent expiry date: 2031-11-10.
- Patent 9850246, product 001; listed patent expiry date: 2033-03-13.
- Patent 9850246, product 002; listed patent expiry date: 2033-03-13.
- Patent 9850246, product 003; listed patent expiry date: 2033-03-13.
- Patent 10117836, product 001; listed patent expiry date: 2035-01-30.
- Patent 10117836, product 002; listed patent expiry date: 2035-01-30.
- Patent 10117836, product 003; listed patent expiry date: 2035-01-30.
- Patent 8754096, product 001; listed patent expiry date: 2035-09-28.
- Patent 8754096, product 002; listed patent expiry date: 2035-09-28.
- Patent 8754096, product 003; listed patent expiry date: 2035-09-28.
- Patent 12383545, product 001; listed patent expiry date: 2039-06-06.
- Patent 12383545, product 002; listed patent expiry date: 2039-06-06.
- Patent 12383545, product 003; listed patent expiry date: 2039-06-06.
- Patent 12090148, product 001; listed patent expiry date: 2041-07-29.
- Patent 12090148, product 002; listed patent expiry date: 2041-07-29.
- Patent 12090148, product 003; listed patent expiry date: 2041-07-29.
- Patent 12465598, product 001; listed patent expiry date: 2042-09-27.
- Patent 12622897, product 001; listed patent expiry date: 2042-09-27.
- Patent 12622897, product 002; listed patent expiry date: 2042-09-27.
- Patent 12350259, product 001; listed patent expiry date: 2043-02-27.
- Exclusivity I-909, product 001; listed exclusivity date: 2026-04-17.
- Exclusivity I-909, product 002; listed exclusivity date: 2026-04-17.
- Exclusivity I-909, product 003; listed exclusivity date: 2026-04-17.
- Exclusivity NCE, product 001; listed exclusivity date: 2026-09-28.
- Exclusivity NCE, product 002; listed exclusivity date: 2026-09-28.
- Exclusivity NCE, product 003; listed exclusivity date: 2026-09-28.

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](https://lmmol.com/compound/QIVUCLWGARAQIO-OLIXTKCUSA-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/ABBV/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

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:NDA215206. FDA data retrieved 2026-08-07.

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