# MAVYRET — FDA application NDA215110

Informational only - not investment advice.

Application NDA215110 · type NDA · FDA status: approved · original approval 2021-06-10

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 | MAVYRET | GLECAPREVIR; PIBRENTASVIR | PELLETS | ORAL | 50MG/PACKET;20MG/PACKET | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10028937, product 001; listed patent expiry date: 2030-06-10.
- Patent 10028937, product 001; listed patent expiry date: 2030-06-10.
- Patent 10039754, product 001; listed patent expiry date: 2030-06-10.
- Patent 10039754, product 001; listed patent expiry date: 2030-06-10.
- Patent 9586978, product 001; listed patent expiry date: 2030-11-06.
- Patent 9586978, product 001; listed patent expiry date: 2030-11-06.
- Patent 10028937, product 001; listed patent expiry date: 2030-12-10.
- Patent 10039754, product 001; listed patent expiry date: 2030-12-10.
- Patent 9586978, product 001; listed patent expiry date: 2031-05-06.
- Patent 8648037, product 001; listed patent expiry date: 2032-01-19.
- Patent 8648037, product 001; listed patent expiry date: 2032-01-19.
- Patent 8937150, product 001; listed patent expiry date: 2032-05-18.
- Patent 8648037, product 001; listed patent expiry date: 2032-07-19.
- Patent 8937150, product 001; listed patent expiry date: 2032-11-18.
- Patent 10286029, product 001; listed patent expiry date: 2034-03-14.
- Patent 10286029, product 001; listed patent expiry date: 2034-03-14.
- Patent 10286029, product 001; listed patent expiry date: 2034-09-14.
- Patent RE48923, product 001; listed patent expiry date: 2035-05-08.
- Patent 9321807, product 001; listed patent expiry date: 2035-06-05.
- Patent RE48923, product 001; listed patent expiry date: 2035-11-08.
- Patent 9321807, product 001; listed patent expiry date: 2035-12-05.
- Exclusivity I-967, product 001; listed exclusivity date: 2028-06-10.
- Exclusivity ODE-372, product 001; listed exclusivity date: 2028-06-10.
- Exclusivity PED, product 001; listed exclusivity date: 2028-12-10.

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

- GLECAPREVIR · UNII K6BUU8J72P · no lmmol compound match
- PIBRENTASVIR · UNII 2WU922TK3L · no lmmol compound match

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:NDA215110. FDA data retrieved 2026-08-07.

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