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Last Updated: May 26, 2022

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-seven 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® Litigation and Generic Entry Outlook for Sprycel

A generic version of SPRYCEL was approved as dasatinib by APOTEX on November 23rd, 2021.

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Drug patent expirations by year for SPRYCEL
Drug Prices for SPRYCEL

See drug prices for SPRYCEL

Recent Clinical Trials for SPRYCEL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Astex Pharmaceuticals, Inc.Phase 2
Butler UniversityPhase 1
National Institutes of Health (NIH)Phase 2

See all SPRYCEL clinical trials

Paragraph IV (Patent) Challenges for SPRYCEL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SPRYCEL Tablets dasatinib 80 mg and 140 mg 021986 1 2011-06-17
SPRYCEL Tablets dasatinib 20 mg, 50 mg, 70 mg and 100 mg 021986 1 2010-06-28

US Patents and Regulatory Information for SPRYCEL

SPRYCEL is protected by two US patents and five FDA Regulatory Exclusivities.

Patents protecting SPRYCEL

Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting SPRYCEL

TREATMENT OF PEDIATRIC PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE (PH+) CHRONIC MYELOID LEUKEMIA (CML) IN CHRONIC PHASE
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-005 Oct 28, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

International Patents for SPRYCEL

See the table below for patents covering SPRYCEL around the world.

Country Patent Number Title Estimated Expiration
China 1989969 Cyclic protein tyrosine kinase inhibitors See Plans and Pricing
European Patent Office 1169038 INHIBITEURS CYCLIQUES DE PROTEINE TYROSINE KINASE (CYCLIC PROTEIN TYROSINE KINASE INHIBITORS) See Plans and Pricing
Czech Republic 20013677 Cyklické inhibitory protein tyrosin kinasy (Cyclic inhibitors of protein tyrosine kinase) See Plans and Pricing
New Zealand 542171 Cyclic protein tyrosine kinase inhibitors See Plans and Pricing
Argentina 044506 INHIBIDORES CICLICOS DE LA PROTEINA TIROSINA CINASA See Plans and Pricing
Japan 2002542193 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SPRYCEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1169038 CA 2013 00006 Denmark See Plans and Pricing PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
1169038 6/2013 Austria See Plans and Pricing PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038 92146 Luxembourg See Plans and Pricing PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1169038 132013902119320 Italy See Plans and Pricing PRODUCT NAME: DASATINIB E I SUOI SALI FARMACEUTICAMENTE ACCETTABILI(SPRYCEL); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/06/363/001 A EU/I/06/363/015, 20061120
1169038 2013C/005 Belgium See Plans and Pricing PRODUCT NAME: DASATINIB SOUS TOUTES FORMES COUVERTES PAR LA PROTECTION DU BREVET DE BASE INCLUANT LES SOLVATES, LES HYDRATES, TEL QUE LA FORME MONOHYDRATEE, ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/06/363/001 20061122
1169038 13C0003 France See Plans and Pricing PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
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Harvard Business School
McKesson
Medtronic

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