# UBRELVY — FDA application NDA211765

Informational only - not investment advice.

Application NDA211765 · type NDA · FDA status: approved · original approval 2019-12-23

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 | UBRELVY | UBROGEPANT | TABLET | ORAL | 50MG | Prescription | not listed | Yes |
| 002 | UBRELVY | UBROGEPANT | TABLET | ORAL | 100MG | 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 9833448, product 001; listed patent expiry date: 2031-11-10.
- Patent 9833448, product 002; listed patent expiry date: 2031-11-10.
- Patent 8754096, product 001; listed patent expiry date: 2032-07-19.
- Patent 8754096, product 002; listed patent expiry date: 2032-07-19.
- Patent 8912210, product 001; listed patent expiry date: 2033-12-23.
- Patent 8912210, product 002; listed patent expiry date: 2033-12-23.
- Patent 10117836, product 001; listed patent expiry date: 2035-01-30.
- Patent 10117836, product 002; listed patent expiry date: 2035-01-30.
- Patent 11925709, product 001; listed patent expiry date: 2035-01-30.
- Patent 11925709, product 002; listed patent expiry date: 2035-01-30.
- Patent 12168004, product 001; listed patent expiry date: 2035-01-30.
- Patent 12168004, product 002; listed patent expiry date: 2035-01-30.
- Patent 12220408, product 001; listed patent expiry date: 2035-01-30.
- Patent 12220408, product 002; listed patent expiry date: 2035-01-30.
- Patent 12310953, product 001; listed patent expiry date: 2035-01-30.
- Patent 12310953, product 002; listed patent expiry date: 2035-01-30.
- Patent 12458632, product 001; listed patent expiry date: 2035-01-30.
- Patent 12458632, product 002; listed patent expiry date: 2035-01-30.
- Patent 12458633, product 001; listed patent expiry date: 2035-01-30.
- Patent 12458633, product 002; listed patent expiry date: 2035-01-30.
- Patent 11717515, product 001; listed patent expiry date: 2041-12-22.
- Patent 11857542, product 001; listed patent expiry date: 2041-12-22.
- Patent 12070450, product 002; listed patent expiry date: 2041-12-22.
- Patent 12194030, product 001; listed patent expiry date: 2041-12-22.
- Patent 12194030, product 001; listed patent expiry date: 2041-12-22.
- Patent 12329750, product 001; listed patent expiry date: 2041-12-22.

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

- UBROGEPANT · UNII AD0O8X2QJR · [lmmol compound DDOOFTLHJSMHLN-ZQHRPCGSSA-N](https://lmmol.com/compound/DDOOFTLHJSMHLN-ZQHRPCGSSA-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:NDA211765. FDA data retrieved 2026-08-07.

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