SPRYCEL — FDA application NDA021986
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 | SPRYCEL | DASATINIB | TABLET | ORAL | 20MG | Prescription | AB | Yes |
| 002 | SPRYCEL | DASATINIB | TABLET | ORAL | 50MG | Prescription | AB | Yes |
| 003 | SPRYCEL | DASATINIB | TABLET | ORAL | 70MG | Prescription | AB | Yes |
| 004 | SPRYCEL | DASATINIB | TABLET | ORAL | 100MG | Prescription | AB | Yes |
| 005 | SPRYCEL | DASATINIB | TABLET | ORAL | 80MG | Prescription | AB | Yes |
| 006 | SPRYCEL | DASATINIB | TABLET | ORAL | 140MG | Prescription | AB | 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 7491725 | 001 | listed patent expiry date: 2026-03-28 | drug substance, drug product |
| Patent 7491725 | 002 | listed patent expiry date: 2026-03-28 | drug substance, drug product |
| Patent 7491725 | 003 | listed patent expiry date: 2026-03-28 | drug substance, drug product |
| Patent 7491725 | 004 | listed patent expiry date: 2026-03-28 | drug substance, drug product |
| Patent 7491725 | 005 | listed patent expiry date: 2026-03-28 | drug substance, drug product |
| Patent 7491725 | 006 | listed patent expiry date: 2026-03-28 | drug substance, drug product |
| Patent 7491725 | 001 | listed patent expiry date: 2026-09-28 | pediatric extension |
| Patent 7491725 | 002 | listed patent expiry date: 2026-09-28 | pediatric extension |
| Patent 7491725 | 003 | listed patent expiry date: 2026-09-28 | pediatric extension |
| Patent 7491725 | 004 | listed patent expiry date: 2026-09-28 | pediatric extension |
| Patent 7491725 | 005 | listed patent expiry date: 2026-09-28 | pediatric extension |
| Patent 7491725 | 006 | listed patent expiry date: 2026-09-28 | pediatric extension |
| Exclusivity ODE-225 | 001 | listed exclusivity date: 2025-12-21 | FDA code as listed |
| Exclusivity ODE-225 | 002 | listed exclusivity date: 2025-12-21 | FDA code as listed |
| Exclusivity ODE-225 | 003 | listed exclusivity date: 2025-12-21 | FDA code as listed |
| Exclusivity ODE-225 | 004 | listed exclusivity date: 2025-12-21 | FDA code as listed |
| Exclusivity ODE-225 | 005 | listed exclusivity date: 2025-12-21 | FDA code as listed |
| Exclusivity ODE-225 | 006 | listed exclusivity date: 2025-12-21 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2026-06-21 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2026-06-21 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2026-06-21 | FDA code as listed |
| Exclusivity PED | 004 | listed exclusivity date: 2026-06-21 | FDA code as listed |
| Exclusivity PED | 005 | listed exclusivity date: 2026-06-21 | FDA code as listed |
| Exclusivity PED | 006 | listed exclusivity date: 2026-06-21 | 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
- DASATINIB · UNII RBZ1571X5H · lmmol compound XHXFZZNHDVTMLI-UHFFFAOYSA-N · CHEMBL5416410
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.