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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Harvard Business School
Deloitte
Boehringer Ingelheim
Fish and Richardson
Moodys
Teva
McKinsey
Covington
Argus Health

Generated: February 17, 2018

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Imatinib mesylate - Generic Drug Details

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What are the generic drug sources for imatinib mesylate and what is the scope of imatinib mesylate freedom to operate?

Imatinib mesylate
is the generic ingredient in two branded drugs marketed by Novartis, Apotex Inc, Mylan Pharms Inc, Sun Pharma Global, and Teva Pharms Usa, and is included in six NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imatinib mesylate has forty-eight patent family members in thirty-one countries.

There are thirty-three drug master file entries for imatinib mesylate. Thirteen suppliers are listed for this compound.
Pharmacology for imatinib mesylate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for imatinib mesylate

US Patents and Regulatory Information for imatinib mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva Pharms Usa IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 204285-002 Aug 4, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apotex Inc IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 079179-002 Aug 5, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharma Global IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 078340-001 Dec 3, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for imatinib mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 ➤ Sign Up ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 ➤ Sign Up ➤ Sign Up
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-001 May 10, 2001 ➤ Sign Up ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for imatinib mesylate

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
7,151,106 Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for imatinib mesylate

Supplementary Protection Certificates for imatinib mesylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
02/005 Ireland ➤ Sign Up PRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012
C0012 France ➤ Sign Up PRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621
00086 Netherlands ➤ Sign Up PRODUCT NAME: IMATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESILAAT; NATL. REGISTRATION NO/DATE: EU/1/01/198/001 - 006 20011107; FIRST REGISTRATION: CH IKS 55807 20010621
C/GB02/016 United Kingdom ➤ Sign Up PRODUCT NAME: IMATINIB (INN I.E. NON INTELLECTUAL PROPRIETARY NAME) OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; REGISTERED: CH IKS-NR: 55807 20010621; UK SG(2001) D/292083 20011108
0564409/01 Switzerland ➤ Sign Up PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Daiichi Sankyo
Chinese Patent Office
Healthtrust
Deloitte
Queensland Health
Fuji
Express Scripts
Cerilliant

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