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Serving leading biopharmaceutical companies globally:

Baxter
US Army
Express Scripts
Chinese Patent Office
AstraZeneca
QuintilesIMS
McKinsey
Johnson and Johnson
Fuji
Covington

Generated: February 18, 2018

DrugPatentWatch Database Preview

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 nineteen patent family members in thirty-nine countries.

The generic ingredient in SPRYCEL is dasatinib. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dasatinib profile page.
Drug patent expirations by year for SPRYCEL
Pharmacology for SPRYCEL
Medical Subject Heading (MeSH) Categories for SPRYCEL

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-005 Oct 28, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-005 Oct 28, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-003 Jun 28, 2006 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for SPRYCEL
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 80 mg and 140 mg ➤ Subscribe 6/17/2011
➤ Subscribe Tablets 80 mg and 140 mg ➤ Subscribe 6/16/2011
➤ Subscribe Tablets 20 mg, 50 mg, 70 mg and 100 mg ➤ Subscribe 6/28/2010

Non-Orange Book US Patents for SPRYCEL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,716,323 Cyclic protein tyrosine kinase inhibitors ➤ Try a Free Trial
8,242,270 Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors ➤ Try a Free Trial
6,979,694 Cyclic protein tyrosine kinase inhibitors ➤ Try a Free Trial
9,382,219 Cyclic protein tyrosine kinase inhibitors ➤ Try a Free Trial
7,091,223 Cyclic protein tyrosine kinase inhibitors ➤ Try a Free Trial
7,189,854 Cyclic protein tyrosine kinase inhibitors ➤ Try a Free Trial
8,993,567 Cyclic protein tyrosine kinase inhibitors ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for SPRYCEL

Supplementary Protection Certificates for SPRYCEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0003 France ➤ Try a Free Trial PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
2013000012 Germany ➤ Try a Free 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
0567 Netherlands ➤ Try a Free Trial PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
146 Luxembourg ➤ Try a Free Trial PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
90004-8 Sweden ➤ Try a Free Trial PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
00567 Netherlands ➤ Try a Free Trial PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120
1169038/01 Switzerland ➤ Try a Free Trial FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
13/003 Ireland ➤ Try a Free Trial PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
2013 00006 Denmark ➤ Try a Free Trial PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Cipla
Teva
Medtronic
Cerilliant
Moodys
Fish and Richardson
Farmers Insurance

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