IMATINIB MESYLATE - Generic Drug Details

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

Imatinib mesylate is the generic ingredient in two branded drugs marketed by Novartis, Amneal Pharms, Apotex, Breckenridge, Chartwell Rx, Dr Reddys, Eugia Pharma, Hikma, Mylan, Natco Pharma Ltd, Qilu Pharm Hainan, Shilpa, Sun Pharm, Teva Pharms Usa, and Zydus Pharms, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-four drug master file entries for imatinib mesylate. Twenty-three suppliers are listed for this compound.

Summary for IMATINIB MESYLATE

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	16
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	363
Patent Applications:	7,205
Drug Prices:	Drug price trends for IMATINIB MESYLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMATINIB MESYLATE
What excipients (inactive ingredients) are in IMATINIB MESYLATE?	IMATINIB MESYLATE excipients list
DailyMed Link:	IMATINIB MESYLATE at DailyMed

See drug prices for IMATINIB MESYLATE

Recent Clinical Trials for IMATINIB MESYLATE

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

Sponsor	Phase
Inhibikase Therapeutics, Inc.	Phase 1
Sarit Assouline	Phase 3
Taizhou Hospital of Zhejiang Province	Phase 2

See all IMATINIB MESYLATE clinical trials

Pharmacology for IMATINIB MESYLATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for IMATINIB MESYLATE

Antineoplastic Agents
Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for IMATINIB MESYLATE

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IMATINIB MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLEEVEC	Tablets	imatinib mesylate	100 mg and 400 mg	021588	1	2007-03-12

US Patents and Regulatory Information for IMATINIB MESYLATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	208429-001	Jan 17, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	204285-001	Aug 4, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	078340-002	Dec 3, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	078340-001	Dec 3, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	207586-001	Jul 13, 2018		DISCN	No	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

Expired US Patents for IMATINIB MESYLATE

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

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