IMATINIB MESYLATE Drug Patent Profile
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Which patents cover Imatinib Mesylate, and what generic alternatives are available?
Imatinib Mesylate is a drug marketed by Amneal Pharms, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Hikma, Mylan, Natco Pharma Ltd, Qilu Pharm Hainan, Shilpa, Sun Pharm, Teva Pharms Usa, Wockhardt Bio Ag, and Zydus Pharms. and is included in fourteen NDAs.
The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Imatinib Mesylate
A generic version of IMATINIB MESYLATE was approved as imatinib mesylate by SUN PHARM on December 3rd, 2015.
Summary 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 |
| First Affiliated Hospital of Zhejiang University | Phase 2 |
Pharmacology for IMATINIB MESYLATE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 210658-002 | Apr 8, 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 | ||||
| Qilu Pharm Hainan | IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 212135-002 | Jun 21, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | |||
| Dr Reddys | IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 206547-001 | Aug 13, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 079179-002 | Aug 5, 2016 | AB | RX | 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 |
