IMATINIB MESYLATE - Generic Drug Details
✉ Email this page to a colleague
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-four 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: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 363 |
Patent Applications: | 7,205 |
Formulation / Manufacturing: | see details |
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 |
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 |
First Affiliated Hospital of Zhejiang University | Phase 2 |
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
Anatomical Therapeutic Chemical (ATC) Classes for IMATINIB MESYLATE
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Natco Pharma Ltd | IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 207818-002 | Mar 1, 2019 | 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 | |||
Eugia Pharma | IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 212773-001 | Jul 23, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amneal Pharms | IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 207495-001 | Feb 8, 2019 | 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
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 | 021588-002 | Apr 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.