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Last Updated: February 25, 2021

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SPRYCEL Drug 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 five patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and twenty-eight 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

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Drug patent expirations by year for SPRYCEL
Drug Prices for SPRYCEL

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Recent Clinical Trials for SPRYCEL

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

SponsorPhase
Baylor College of MedicinePhase 2
National Cancer Institute (NCI)Phase 3
Sundeep Khosla, M.D.Phase 2

See all SPRYCEL clinical trials

Pharmacology for SPRYCEL
Paragraph IV (Patent) Challenges for SPRYCEL
Tradename Dosage Ingredient NDA Submissiondate
SPRYCEL TABLET;ORAL dasatinib 021986 2011-06-17
SPRYCEL TABLET;ORAL dasatinib 021986 2010-06-28

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
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 RX Yes Yes   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

Expired US Patents for SPRYCEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-005 Oct 28, 2010   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-003 Jun 28, 2006   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for SPRYCEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1169038 6/2013 Austria   Start Trial PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; 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
1169038 132013902119320 Italy   Start Trial 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 1390004-8 Sweden   Start Trial PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
1169038 C01169038/01 Switzerland   Start Trial FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Colorcon
Harvard Business School
McKesson
Medtronic

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