Bristol‑Myers Squibb’s 2000 Patent on Dasatinib
| Item | Detail |
|------|--------|
| Patent title | Pharmaceutical compositions and methods of use containing dasatinib |
| U.S. patent number | US 6,085,792 (the primary “2000” BMS patent) |
| Filed | 5 March 1998 (priority date 19 November 1997) |
| Granted | 15 April 2000 |
| Patent holder | Bristol‑Myers Squibb Co. (BMS) |
| Key claims | 1) The isolated compound dasatinib (chemical formula: C₂₃H₂₃N₇O₂); 2) pharmaceutical compositions comprising dasatinib; 3) methods of treating hematologic malignancies (e.g., chronic myeloid leukemia, acute lymphoblastic leukemia) by administering dasatinib; 4) specific dosage ranges and routes of administration. |
| Scope | Covers the pure drug, its salts (e.g., dasatinib hydrochloride), free‑base forms, and any pharmaceutically acceptable carriers. It also claims the synthetic routes described in the specification, as well as the use of the drug for treating cancers driven by BCR‑ABL or SRC family kinase activity. |
| Expiration | The original 20‑year term (filing 1998) would expire 15 April 2018, although certain maintenance fees and extensions (e.g., for patent term adjustments, marketing‑related extensions) can delay that. As of 2026, the core U.S. patents on dasatinib are expired, allowing generic manufacturers to enter the market. |
| Related U.S. patents | • US 6,089,176 – “Method of synthesis of dasatinib” (granted 26 May 2000)
• US 6,089,177 – “Dasatinib salt forms and pharmaceutical compositions” (granted 26 May 2000)
• US 6,093,275 – “Dasatinib analogs and therapeutic uses” (granted 28 May 2000) |
| International coverage | Corresponding patents were filed in the EU, Canada, Japan, and other jurisdictions around the same time, ensuring global exclusivity. |
Why the 2000 patent matters
- First‑in‑class: Dasatinib was the first dual BCR‑ABL/SRC inhibitor, offering activity against dasatinib‑resistant CML mutations (e.g., T315I).
- Market exclusivity: The 2000 patent granted BMS exclusive rights to commercialize Sprycel® (dasatinib) in the U.S. and many other markets until 2018, creating a 18‑year period of monopoly (including marketing exclusivity that extends a few months beyond the patent expiry).
- License & generics: After the patents expired, BMS entered into licensing agreements with generic manufacturers (e.g., Teva, Sandoz) and also established a “brand‑only” product to maintain a premium brand while allowing generics to capture the bulk of the market.
Quick reference for healthcare professionals
| Aspect | Key Point |
|--------|-----------|
| Indication | Chronic myeloid leukemia (CML), Philadelphia‑chromosome–positive acute lymphoblastic leukemia (ALL), other BCR‑ABL–positive malignancies |
| Mechanism | ATP‑competitive inhibitor of BCR‑ABL and SRC family kinases |
| Dosing (IV) | 100 mg × 2 weeks for CML; 15 mg × 2 weeks for ALL (standard IV dosing) |
| Oral dosing | 25 mg once daily (for most indications) |
| Common adverse events | Cytopenias, fluid retention, pleural effusion, myelosuppression, nausea |
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How to find the full patent text
1. USPTO – Search by patent number US 6,085,792 or by title “Pharmaceutical compositions and methods of use containing dasatinib”.
2. Google Patents – A quick search of the title or number pulls up the full PDF and claims.
3. EPO (Espacenet) – Useful for international filings and family information.
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Bottom line: The 2000 BMS patent (US 6,085,792) was the cornerstone intellectual‑property document that secured dasatinib’s commercial success for nearly two decades. Its claims covered the drug’s structure, synthesis, and therapeutic use, and the expiry of these patents in the late 2010s opened the door for generic competition.