DrugPatentWatch Database Preview
SPRYCEL Drug Profile
When do Sprycel patents expire, and when can generic versions of Sprycel launch?
Sprycel is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are five patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and twenty-one patent family members in thirty-nine countries.
The generic ingredient in SPRYCEL is dasatinib. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dasatinib profile page.
Summary for SPRYCEL
| International Patents: | 121 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 116 |
| Clinical Trials: | 53 |
| Patent Applications: | 5,045 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SPRYCEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SPRYCEL |
| DailyMed Link: | SPRYCEL at DailyMed |
Recent Clinical Trials for SPRYCEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jorge J. Castillo, MD | Phase 1 |
| ECOG-ACRIN Cancer Research Group | Phase 2 |
| Southwest Oncology Group | Phase 2 |
Recent Litigation for SPRYCEL
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Pfizer Inc. v. Zydus Pharmaceuticals USA Inc. | 2012-06-22 |
| BRISTOL-MYERS SQUIBB COMPANY v. APOTEX, INC. | 2010-11-08 |
Pharmacology for SPRYCEL
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors |
Synonyms for SPRYCEL
| 1N1 |
| 2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)-N-(2-chloro-6-methylphenyl)thiazole-5-carboxamide |
| 2-{6-[4-(2-Hydroxy-ethyl)-piperazin-1-yl]-2-methyl-pyrimidin-4-ylamino}-thiazole-5-carboxylic acid (2-chloro-6-methyl-phenyl)-amide |
| 2359AH |
| 302962-49-8 |
| 302962-49-8 pound not863127-77-9 |
| 49310-EP2270008A1 |
| 49310-EP2292617A1 |
| 49310-EP2311840A1 |
| 5-Thiazolecarboxamide, monohydrate |
| 5-Thiazolecarboxamide, N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)-1-piperazinyl)-2-methyl-4-pyrimidinyl)amino)- |
| 5-Thiazolecarboxamide, N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]- |
| A-2429 |
| AB0066750 |
| AB01273956_03 |
| AB01273956-01 |
| AB01273956-02 |
| AC-22749 |
| AC1MI3ET |
| AC1Q2P0C |
| AKOS015902363 |
| AM20080877 |
| AN-5289 |
| anh. dasatinib |
| anhydrous dasatinib |
| ANW-43935 |
| AOB87355 |
| API0002220 |
| AX8035158 |
| BCB03_000715 |
| BCP01797 |
| BCP9000589 |
| BCPP000263 |
| BDBM13216 |
| BMS 345825 |
| BMS 354825 |
| BMS 354825; Sprycel |
| BMS 354825|||Sprycel |
| BMS 35482513 |
| BMS Dasatinib |
| BMS-354825 |
| BMS-354825-03 |
| BMS-354825;BMS354825;BMS 354825 |
| BMS354825 |
| BR-47532 |
| BRD-K49328571-001-05-1 |
| BRD-K49328571-001-07-7 |
| CAS-302962-49-8 |
| CD0138 |
| CHEBI:49375 |
| CHEMBL1421 |
| cid_3062316 |
| CS-0100 |
| CTK8B4120 |
| D-3307 |
| D03658 |
| Dasatinib |
| Dasatinib - BMS-354825 |
| dasatinib (anh.) |
| Dasatinib (anhydrous) |
| Dasatinib (BMS-354825) |
| Dasatinib (JAN/INN) |
| Dasatinib [USAN:INN] |
| Dasatinib [USAN] |
| Dasatinib anhydrous |
| Dasatinib BMS-354825 |
| Dasatinib D8 |
| Dasatinib, BMS 354825 |
| Dasatinib,BMS-354825 |
| Dasatinib; |
| dasatinibum |
| DB01254 |
| DSSTox_CID_20979 |
| DSSTox_GSID_40979 |
| DSSTox_RID_79608 |
| DTXSID4040979 |
| EN002710 |
| EX-A401 |
| FC0026 |
| FT-0084503 |
| FT-0650671 |
| GS-6548 |
| GTPL5678 |
| HMS2043N05 |
| HMS3244A05 |
| HMS3244A06 |
| HMS3244B05 |
| HMS3265C19 |
| HMS3265C20 |
| HMS3265D19 |
| HMS3265D20 |
| HMS3654K05 |
| HY-10181 |
| I14-1972 |
| KB-274688 |
| KB-76415 |
| Kinome_3650 |
| KS-0000027F |
| LS-186641 |
| LS-187028 |
| LS-187773 |
| MLS003915609 |
| MLS004774145 |
| MLS006010904 |
| MolPort-003-846-143 |
| N-(2-chloro-6-methyl-phenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methyl-pyrimidin-4-yl]amino]thiazole-5-carboxamide |
| n-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)amino)-1,3-thiazole-5-carboxamide |
| N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)amino)thiazole-5-carboxamide |
| N-(2-CHLORO-6-METHYLPHENYL)-2-({6-[4-(2-HYDROXYETHYL)PIPERAZIN-1-YL]-2-METHYLPYRIMIDIN-4-YL}AMINO)-1,3-THIAZOLE-5-CARBOXAMIDE |
| N-(2-chloro-6-methylphenyl)-2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thia |
| N-(2-chloro-6-methylphenyl)-2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thiazole-5-carboxamide |
| N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl)]-2-methyl-4-pyrimidinyl]amino)]-1,3-thiazole-5-carboxamide |
| N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl]amino]-1,3-thiazole-5-carboxamide |
| NCGC00181129-01 |
| NCGC00181129-02 |
| NCGC00181129-03 |
| NCGC00181129-05 |
| NCGC00181129-06 |
| NCGC00181129-12 |
| NSC-732517 |
| NSC-759877 |
| NSC732517 |
| NSC759877 |
| OR302638 |
| Pharmakon1600-01502275 |
| Q-101345 |
| QCR-106 |
| RTR-013021 |
| RTR-021205 |
| s1021 |
| SB17284 |
| SC-22079 |
| SCHEMBL8226 |
| SMR002529551 |
| Sprycel (Bristol Meyers) |
| SR-00000000554 |
| SR-00000000554-5 |
| ST2419212 |
| SW208076-5 |
| SYN1036 |
| Tox21_112736 |
| Tox21_112736_1 |
| TR-013021 |
| TRA0075817 |
| UNII-X78UG0A0RN |
| X78UG0A0RN |
| Z2786158251 |
| ZBNZXTGUTAYRHI-UHFFFAOYSA-N |
| ZINC3986735 |
US Patents and Regulatory Information for SPRYCEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-005 | Oct 28, 2010 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-003 | Jun 28, 2006 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-005 | Oct 28, 2010 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Paragraph IV (Patent) Challenges for SPRYCEL
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 80 mg and 140 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Tablets | 80 mg and 140 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Tablets | 20 mg, 50 mg, 70 mg and 100 mg | ➤ Subscribe | Start Trial |
International Patents for SPRYCEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2312860 | Start Trial |
| Slovenia | 1610780 | Start Trial |
| Portugal | 1711481 | Start Trial |
| South Africa | 200107204 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SPRYCEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1169038 | C01169038/01 | Switzerland | Start Trial | FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH |
| 1169038 | C300567 | Netherlands | Start Trial | PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120 |
| 1169038 | 1390004-8 | Sweden | Start Trial | PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120 |
| 1169038 | 300567 | Netherlands | Start Trial | PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
