ELIQUIS — FDA application NDA202155
Listed sponsor: BRISTOL MYERS SQUIBB · BMY company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 6967208 | 001 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1501 |
| Patent 6967208 | 001 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1200 |
| Patent 6967208 | 001 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1302 |
| Patent 6967208 | 001 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1729 |
| Patent 6967208 | 001 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1730 |
| Patent 6967208 | 001 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1301 |
| Patent 6967208 | 001 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1167 |
| Patent 6967208 | 001 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-4178 |
| Patent 6967208 | 001 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1323 |
| Patent 6967208 | 001 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1502 |
| Patent 6967208 | 002 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1301 |
| Patent 6967208 | 002 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1200 |
| Patent 6967208 | 002 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1302 |
| Patent 6967208 | 002 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-1323 |
| Patent 6967208 | 002 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-4178 |
| Patent 6967208 | 003 | listed patent expiry date: 2026-11-21 | drug substance, drug product, U-4179 |
| Patent 6967208 | 001 | listed patent expiry date: 2027-05-21 | pediatric extension |
| Patent 6967208 | 002 | listed patent expiry date: 2027-05-21 | pediatric extension |
| Patent 6967208 | 003 | listed patent expiry date: 2027-05-21 | pediatric extension |
| Patent 9326945 | 001 | listed patent expiry date: 2031-02-24 | drug product |
| Patent 9326945 | 002 | listed patent expiry date: 2031-02-24 | drug product |
| Patent 9326945 | 003 | listed patent expiry date: 2031-02-24 | drug product |
| Patent 9326945 | 001 | listed patent expiry date: 2031-08-24 | pediatric extension |
| Patent 9326945 | 002 | listed patent expiry date: 2031-08-24 | pediatric extension |
| Patent 9326945 | 003 | listed patent expiry date: 2031-08-24 | pediatric extension |
| Exclusivity NPP | 001 | listed exclusivity date: 2028-04-17 | FDA code as listed |
| Exclusivity NPP | 002 | listed exclusivity date: 2028-04-17 | FDA code as listed |
| Exclusivity NS | 003 | listed exclusivity date: 2028-04-17 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2028-10-17 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2028-10-17 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2028-10-17 | FDA code as listed |
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 · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.