# SPRYCEL — FDA application NDA021986

Informational only - not investment advice.

Application NDA021986 · type NDA · FDA status: approved · original approval 2006-06-28

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 | 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 |

## Orange Book patent and exclusivity listings

- Patent 7491725, product 001; listed patent expiry date: 2026-03-28.
- Patent 7491725, product 002; listed patent expiry date: 2026-03-28.
- Patent 7491725, product 003; listed patent expiry date: 2026-03-28.
- Patent 7491725, product 004; listed patent expiry date: 2026-03-28.
- Patent 7491725, product 005; listed patent expiry date: 2026-03-28.
- Patent 7491725, product 006; listed patent expiry date: 2026-03-28.
- Patent 7491725, product 001; listed patent expiry date: 2026-09-28.
- Patent 7491725, product 002; listed patent expiry date: 2026-09-28.
- Patent 7491725, product 003; listed patent expiry date: 2026-09-28.
- Patent 7491725, product 004; listed patent expiry date: 2026-09-28.
- Patent 7491725, product 005; listed patent expiry date: 2026-09-28.
- Patent 7491725, product 006; listed patent expiry date: 2026-09-28.
- Exclusivity ODE-225, product 001; listed exclusivity date: 2025-12-21.
- Exclusivity ODE-225, product 002; listed exclusivity date: 2025-12-21.
- Exclusivity ODE-225, product 003; listed exclusivity date: 2025-12-21.
- Exclusivity ODE-225, product 004; listed exclusivity date: 2025-12-21.
- Exclusivity ODE-225, product 005; listed exclusivity date: 2025-12-21.
- Exclusivity ODE-225, product 006; listed exclusivity date: 2025-12-21.
- Exclusivity PED, product 001; listed exclusivity date: 2026-06-21.
- Exclusivity PED, product 002; listed exclusivity date: 2026-06-21.
- Exclusivity PED, product 003; listed exclusivity date: 2026-06-21.
- Exclusivity PED, product 004; listed exclusivity date: 2026-06-21.
- Exclusivity PED, product 005; listed exclusivity date: 2026-06-21.
- Exclusivity PED, product 006; listed exclusivity date: 2026-06-21.

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](https://lmmol.com/compound/XHXFZZNHDVTMLI-UHFFFAOYSA-N)

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:NDA021986. FDA data retrieved 2026-08-07.

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