# SUNLENCA — FDA application NDA215974

Informational only - not investment advice.

Application NDA215974 · type NDA · FDA status: approved · original approval 2022-12-22

Listed sponsor: GILEAD SCIENCES INC · [GILD company profile](/company/GILD/) · 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 | SUNLENCA | LENACAPAVIR SODIUM | TABLET | ORAL | EQ 300MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 9951043, product 001; listed patent expiry date: 2034-02-28.
- Patent 10071985, product 001; listed patent expiry date: 2037-08-17.
- Patent 10654827, product 001; listed patent expiry date: 2037-08-17.
- Patent 11267799, product 001; listed patent expiry date: 2038-08-16.
- Patent 11944611, product 001; listed patent expiry date: 2041-08-28.
- Exclusivity NCE, product 001; listed exclusivity date: 2027-12-22.

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

- LENACAPAVIR SODIUM · UNII BDT58WJ9WE · 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/GILD/)
- [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:NDA215974. FDA data retrieved 2026-08-07.

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