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-one branded drugs marketed by Sun Pharm, Saptalis Pharms, Vistapharm, 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 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 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 twenty-seven 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-nine suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for METFORMIN HYDROCHLORIDE

International Patents:	55
US Patents:	10
Tradenames:	21
Applicants:	79
NDAs:	127
Drug Master File Entries:	43
Finished Product Suppliers / Packagers:	89
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

See all METFORMIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	500MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	1GM; EQ 100MG BASE	TABLET, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	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

Hypoglycemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for METFORMIN HYDROCHLORIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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

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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
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Rk Pharma	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	215629-001	Jun 20, 2023	AB3	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	091273-002	Apr 16, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	077337-004	May 7, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	214629-002	Feb 22, 2022	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212681-001	Jun 9, 2022	AB3	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

Expired US Patents for METFORMIN HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003	⤷ Sign Up	⤷ Sign Up
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004	⤷ Sign Up	⤷ Sign Up
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004	⤷ Sign Up	⤷ Sign Up
Ranbaxy	RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591-001	Sep 11, 2003	⤷ Sign Up	⤷ Sign Up
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	⤷ Sign Up	⤷ Sign Up
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for METFORMIN HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Denmark	1476138		⤷ Sign Up
Canada	3021475		⤷ Sign Up
Australia	2015254875		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2017182851		⤷ Sign Up
European Patent Office	3137060		⤷ Sign Up
New Zealand	535455	Controlled release dosage forms	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	92128	Luxembourg	⤷ Sign Up	PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2498758	132020000000034	Italy	⤷ Sign Up	PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
1412357	132008901682802	Italy	⤷ Sign Up	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
2498758	122020000018	Germany	⤷ Sign Up	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
1412357	122008000046	Germany	⤷ Sign Up	PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
1506211	300677	Netherlands	⤷ Sign Up	PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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