METFORMIN HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for metformin hydrochloride and what is the scope of patent protection?
Metformin hydrochloride
is the generic ingredient in twenty branded drugs marketed by Sun Pharm, Annora Pharma, Bionpharma, Saptalis Pharms, Vistapharm Llc, Ranbaxy, Andrx Labs Llc, Emd Serono Inc, Santarus Inc, Actavis Elizabeth, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Harman Finochem, Impax Labs, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Medicap Labs, 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 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, Takeda Pharms Usa, Chartwell Rx, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, Dr Reddys Labs Sa, and Msd Sub Merck, and is included in one hundred and thirty NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Metformin hydrochloride has fifty-five patent family members in sixteen countries.
There are forty-three drug master file entries for metformin hydrochloride. Eighty-five suppliers are listed for this compound. There are seven tentative approvals for this compound.
Summary for METFORMIN HYDROCHLORIDE
International Patents: | 55 |
US Patents: | 10 |
Tradenames: | 20 |
Applicants: | 82 |
NDAs: | 130 |
Drug Master File Entries: | 43 |
Finished Product Suppliers / Packagers: | 85 |
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 |
James Wang | Phase 1 |
United States Department of Defense | Phase 1 |
Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try for Free | ⤷ Try for Free | 500MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Try for Free | ⤷ Try for Free | 1GM; EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL |
⤷ Try for Free | ⤷ Try for Free | 1GM; EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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
Expired US Patents for METFORMIN HYDROCHLORIDE
International Patents for METFORMIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3288549 | ⤷ Try for Free | |
Canada | 2476201 | FORMULATIONS A LIBERATION MODIFIEE D'AU MOINS UNE FORME DE TRAMADOL (MODIFIED RELEASE FORMULATIONS OF AT LEAST ONE FORM OF TRAMADOL) | ⤷ Try for Free |
European Patent Office | 3137060 | ⤷ Try for Free | |
Australia | 2017254908 | ⤷ Try for Free | |
Japan | 2018517460 | 徐放性懸濁組成物用のデュアルチャンバーパック | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 03072089 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1412357 | SPC/GB08/040 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716 |
2498758 | 122020000018 | Germany | ⤷ Try for Free | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
2498758 | 301040 | Netherlands | ⤷ Try for Free | PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113 |
1412357 | C 2008 016 | Romania | ⤷ Try for Free | PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408 |
1506211 | 179 5017-2014 | Slovakia | ⤷ Try for Free | PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116 |
1412357 | 132008901682802 | Italy | ⤷ Try for Free | PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Metformin Hydrochloride
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