SPRYCEL Drug Patent Profile
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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 two patents protecting this drug and two Paragraph IV challenges.
This drug has forty-eight patent family members in twenty-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.
DrugPatentWatch® Generic Entry Outlook for Sprycel
Sprycel was eligible for patent challenges on June 28, 2010.
There have been seven 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.
There are three tentative approvals for the generic drug (dasatinib), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for SPRYCEL
International Patents: | 48 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 176 |
Patent Applications: | 3,095 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SPRYCEL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SPRYCEL |
What excipients (inactive ingredients) are in SPRYCEL? | SPRYCEL excipients list |
DailyMed Link: | SPRYCEL at DailyMed |


Recent Clinical Trials for SPRYCEL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fernando De la Garza Salazar | Phase 2 |
Hospital Universitario Dr. Jose E. Gonzalez | Phase 2 |
Lew Lipsitz | Phase 1/Phase 2 |
Pharmacology for SPRYCEL
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for SPRYCEL
US Patents and Regulatory Information for SPRYCEL
SPRYCEL is protected by two US patents and four FDA Regulatory Exclusivities.
Patents protecting SPRYCEL
Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting SPRYCEL
TREATMENT OF PEDIATRIC PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE (PH+) CHRONIC MYELOID LEUKEMIA (CML) IN CHRONIC PHASE
Exclusivity Expiration: ⤷ Try a Trial
INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-004 | May 30, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SPRYCEL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-003 | Jun 28, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-004 | May 30, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-001 | Jun 28, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPRYCEL
See the table below for patents covering SPRYCEL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Chile | 2004000610 | COMPUESTOS HETEROCICLICOS, INHIBIDORES DE LA PROTEINA TIROSINA QUINASA, UTILES PARA PREPARAR UN MEDICAMENTO PARA TRATAR ARTRITIS REUMATOIDE, ESCLEROSIS MULTIPLE, ENFERMEDAD INFLAMATORIA DEL INTESTINO, LUPUS, CANCER Y OTRAS. | ⤷ Try a Trial |
Luxembourg | 92146 | ⤷ Try a Trial | |
Russian Federation | 2365372 | ЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ПРОТЕИНТИРОЗИНКИНАЗ (CYCLIC PROTEIN TYROSINE KINASE INHIBITORS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPRYCEL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1169038 | 1390004-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120 |
1169038 | C300567 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120 |
1169038 | 92146 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |