METFORMIN HYDROCHLORIDE Drug Patent Profile
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When do Metformin Hydrochloride patents expire, and when can generic versions of Metformin Hydrochloride launch?
Metformin Hydrochloride is a drug marketed by Saptalis Pharms, Vistapharm, Actavis Elizabeth, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Harman Finochem, Impax Labs, Intellipharmaceutics, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Micro Labs, Mylan Pharms Inc, Norvium Bioscience, Nostrum Labs Inc, Nostrum Pharms Llc, Novast Labs, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Rk Pharma, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Twi Pharms, Unichem, Utopic Pharms, Watson Labs Inc, Yichang Humanwell, Zydus Lifesciences, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma Llc, Granules India, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Mylan, Provident Pharm, Sun Pharm Inds Inc, Sunshine, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Zydus Pharms Usa, and Dr Reddys Labs Sa. and is included in one hundred and two NDAs.
The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Metformin Hydrochloride
A generic version of METFORMIN HYDROCHLORIDE was approved as metformin hydrochloride; saxagliptin hydrochloride by DR REDDYS LABS SA on August 9th, 2023.
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Summary for METFORMIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 68 |
| NDAs: | 102 |
| Finished Product Suppliers / Packagers: | 87 |
| Raw Ingredient (Bulk) Api Vendors: | 164 |
| Clinical Trials: | 2,583 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METFORMIN HYDROCHLORIDE |
| What excipients (inactive ingredients) are in METFORMIN HYDROCHLORIDE? | METFORMIN HYDROCHLORIDE excipients list |
| DailyMed Link: | METFORMIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for METFORMIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Arthritis Foundation | Phase 2 |
| United States Department of Defense | Phase 1 |
| James Wang | Phase 1 |
Pharmacology for METFORMIN HYDROCHLORIDE
| Drug Class | Biguanide |
Medical Subject Heading (MeSH) Categories for METFORMIN HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for METFORMIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| RIOMET | Oral Solution | metformin hydrochloride | 500 mg/5 mL | 021591 | 1 | 2018-02-02 |
| GLUMETZA | Extended-release Tablets | metformin hydrochloride | 500 mg and 1000 mg | 021748 | 1 | 2009-07-27 |
| FORTAMET | Extended-release Tablets | metformin hydrochloride | 500 mg and 1000 mg | 021574 | 1 | 2008-10-14 |
US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Qingdao Baheal Pharm | METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209993-001 | Dec 27, 2018 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Lifesciences | METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 077060-001 | Apr 20, 2005 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Intellipharmaceutics | METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202306-002 | Feb 23, 2017 | 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 |
