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SPRYCEL Drug Profile
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» See Plans and PricingWhen 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-four 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.
US ANDA Litigation and Generic Entry Outlook for Sprycel
Sprycel was eligible for patent challenges on June 28, 2010.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for SPRYCEL
| International Patents: | 124 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 117 |
| Clinical Trials: | 55 |
| Patent Applications: | 4,955 |
| 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 |
|---|---|
| Indiana University | Phase 1 |
| Butler University | Phase 1 |
| Hala Fadda | Phase 1 |
Recent Litigation for SPRYCEL
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Wyeth LLC v. Sun Pharmaceutical Industries, Inc. | 2016-12-23 |
| 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 |
| AK-47532 |
| AKOS015902363 |
| AM20080877 |
| anh. dasatinib |
| anhydrous dasatinib |
| ANW-43935 |
| AOB87355 |
| API0002220 |
| AR-270/43507994 |
| AX8035158 |
| BCB03_000715 |
| BCP01797 |
| BCP9000589 |
| BCPP000263 |
| BDBM13216 |
| BMS 345825 |
| BMS 354825 |
| BMS 354825|||Sprycel |
| BMS 35482513 |
| BMS Dasatinib |
| BMS-354825 |
| BMS-354825 HYDRATE |
| 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, BMS 354825 |
| Dasatinib,BMS-354825 |
| dasatinibum |
| DB01254 |
| DSSTox_CID_20979 |
| DSSTox_GSID_40979 |
| DSSTox_RID_79608 |
| DTXSID4040979 |
| EC-000.2122 |
| EN002710 |
| EX-A401 |
| FT-0084503 |
| FT-0650671 |
| GS-6548 |
| GTPL5678 |
| HMS2043N05 |
| HMS3244A05 |
| HMS3244A06 |
| HMS3244B05 |
| HMS3265C19 |
| HMS3265C20 |
| HMS3265D19 |
| HMS3265D20 |
| HMS3654K05 |
| HMS3744C11 |
| HY-10181 |
| Kinome_3650 |
| KS-0000027F |
| LS-186641 |
| LS-187028 |
| LS-187773 |
| MLS003915609 |
| MLS004774145 |
| MLS006010904 |
| 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)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 |
| 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 |
| NCGC00481571-01 |
| NSC-732517 |
| NSC-759877 |
| NSC732517 |
| NSC759877 |
| OR302638 |
| Pharmakon1600-01502275 |
| Q-101345 |
| Q419940 |
| 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 |
International Patents for SPRYCEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1610780 | Start Trial |
| Portugal | 1169038 | Start Trial |
| Russian Federation | 2007120710 | Start Trial |
| Canada | 2555291 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SPRYCEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1169038 | CA 2013 00006 | Denmark | Start Trial | PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122 |
| 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 | 2013/003 | Ireland | Start Trial | PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120 |
| 1169038 | 122013000012 | Germany | Start Trial | PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH GEEIGNETE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-009 EU/1/06/363/010-011 EU/1/06/363/012-015 20061120 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
