# ELIQUIS — FDA application NDA202155

Informational only - not investment advice.

Application NDA202155 · type NDA · FDA status: approved · original approval 2012-12-28

Listed sponsor: BRISTOL MYERS SQUIBB · [BMY company profile](/company/BMY/) · 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 | ELIQUIS | APIXABAN | TABLET | ORAL | 2.5MG | Prescription | AB | Yes |
| 002 | ELIQUIS | APIXABAN | TABLET | ORAL | 5MG | Prescription | AB | Yes |
| 003 | ELIQUIS | APIXABAN | TABLET, FOR SUSPENSION | ORAL | 0.5MG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 6967208, product 001; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 001; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 001; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 001; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 001; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 001; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 001; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 001; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 001; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 001; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 002; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 002; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 002; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 002; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 002; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 003; listed patent expiry date: 2026-11-21.
- Patent 6967208, product 001; listed patent expiry date: 2027-05-21.
- Patent 6967208, product 002; listed patent expiry date: 2027-05-21.
- Patent 6967208, product 003; listed patent expiry date: 2027-05-21.
- Patent 9326945, product 001; listed patent expiry date: 2031-02-24.
- Patent 9326945, product 002; listed patent expiry date: 2031-02-24.
- Patent 9326945, product 003; listed patent expiry date: 2031-02-24.
- Patent 9326945, product 001; listed patent expiry date: 2031-08-24.
- Patent 9326945, product 002; listed patent expiry date: 2031-08-24.
- Patent 9326945, product 003; listed patent expiry date: 2031-08-24.
- Exclusivity NPP, product 001; listed exclusivity date: 2028-04-17.
- Exclusivity NPP, product 002; listed exclusivity date: 2028-04-17.
- Exclusivity NS, product 003; listed exclusivity date: 2028-04-17.
- Exclusivity PED, product 001; listed exclusivity date: 2028-10-17.
- Exclusivity PED, product 002; listed exclusivity date: 2028-10-17.
- Exclusivity PED, product 003; listed exclusivity date: 2028-10-17.

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

- APIXABAN · UNII not resolved · 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/BMY/)
- [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:NDA202155. FDA data retrieved 2026-08-07.

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