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METFORMIN HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for metformin hydrochloride and what is the scope of metformin hydrochloride patent protection?

Metformin hydrochloride is the generic ingredient in sixteen branded drugs marketed by Sun Pharm Inds Ltd, Andrx Labs Llc, Bristol Myers Squibb, Santarus Inc, Actavis Elizabeth, Actavis Labs Fl Inc, Alignscience Pharma, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cspc Ouyi Pharm Co, Granules India Ltd, Impax Labs, Intellipharmaceutics, Inventia Hlthcare, Ivax Sub Teva Pharms, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Mylan, Mylan Pharms Inc, Nostrum Labs Inc, Nostrum Pharms Llc, Ranbaxy Labs Ltd, Sandoz, Sun Pharm Inds (in), Sun Pharm Industries, Sun Pharma Global, Teva, Torrent Pharms Ltd, Watson Labs Inc, Zydus Pharms Usa, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell Life Sci, Dr Reddys Labs Inc, Glenmark Generics, Granules India, Indicus Pharma, Ipca Labs Ltd, Provident Pharm, Sciegen Pharms Inc, Sun Pharm Inds Inc, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Takeda Pharms Usa, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, and Merck Sharp Dohme, and is included in ninety-five NDAs. There are thirty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride has one hundred and twenty-three patent family members in thirty-three countries.

There are forty-eight drug master file entries for metformin hydrochloride. One hundred and fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for METFORMIN HYDROCHLORIDE

International Patents:	123
US Patents:	31
Tradenames:	16
Applicants:	56
NDAs:	95
Drug Master File Entries:	48
Suppliers / Packagers:	114
Bulk Api Vendors:	111
Clinical Trials:	1,901
Patent Applications:	38
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METFORMIN HYDROCHLORIDE
DailyMed Link:	METFORMIN HYDROCHLORIDE at DailyMed

Pharmacology for METFORMIN HYDROCHLORIDE

Ingredient-type	Biguanides
Drug Class	Biguanide

Medical Subject Heading (MeSH) Categories for METFORMIN HYDROCHLORIDE

Hypoglycemic Agents

Synonyms for METFORMIN HYDROCHLORIDE

(E)-2-carbamimidoyl-1,1-dimethylguanidine hydrochloride
1-dimethylbiguanide hydrochloride
1,1-Dimethylbiguanide hydrochloride
1,1-Dimethylbiguanide hydrochloride, 97%
1,1-Dimethylbiguanide monohydrochloride
1,1-Dimethylbiguanide, Hydrochloride
1115-70-4
144377-16-2
15537-72-1
3-(diaminomethylene)-1,1-dimethyl-guanidine hydrochloride
3-(diaminomethylidene)-1,1-dimethylguanidine hydrochloride
3-carbamimidoyl-1,1-dimethylguanidine;hydrochloride
56258-19-6
786Z46389E
AB0004717
AB1009370
AC-2075
AC1L23D5
ACMC-20ap7s
AI3-51264
AK163172
AKOS015894259
AN-8747
API0003318
Apo-Metformin
AX8041182
BB_SC-5098
BC206669
Benofomin
BG0401
BIGUANIDE, 1,1-DIMETHYL-, HYDROCHLORIDE
Biguanide, 1,1-dimethyl-, monohydrochloride
Biguanide, 1,1-dimethyl-, monohydrochloride (8CI)
Biguanide,1-dimethyl-, monohydrochloride
Biocos
BP-12830
C4H11N5.HCl
C4H12ClN5
CAS-1115-70-4
CCG-208004
CHEBI:6802
CHEMBL1703
Cidophage
CS-1851
CTK8C6229
D 15095
D.B.I
D.B.I.
D00944
Dabex
DB-018697
Denkaform
Dextin
Diabefagos
Diaberit
Diabesin
Diabetex
Diabetmin
Diaformin
Diamin
Diaphage
Diformin
Diformin Retard
Dimethylbiguanide hydrochloride
DMBG hydrochloride
DMGG hydrochloride
DSSTox_CID_17246
DSSTox_GSID_37246
DSSTox_RID_79314
DTXSID9037246
EC 214-230-6
EINECS 214-230-6
F2173-0894
Fornidd
Fortamet
FT-0628265
Geamet
Glibomet
Glucofago
Glucoform
Glucoliz
Glucomet
Glucomine
Gluconil
Glucophage
Glucophage (TN)
Glucophage 850
Glucophage Forte
Glucophage Retard
Glucophage XR
Glucophage-Mite
Gluformin
Glupermin
Glyciphage
Glycoran
Glyformin
GP2747
Haurymellin hydrochloride
HMS1568A09
HMS1922H14
HSDB 7080
HY-17471A
I05-0228
I14-7880
I506
Imidodicarbonimidic diamide, N,N-dimethyl-, monohydrochloride
Imidodicarbonimidic diamide, N,N-dimethyl-, monohydrochloride (9CI)
Imidodicarbonimidic diamide,N-dimethyl-, monohydrochloride
Islotin retard
J10020
J10377
Jsp000870
KS-000006B5
KS-1272
KSC926E2T
LA 6023
LA 6063
LS-43900
M-2922
M2009
MCULE-9784059944
Meglucon
Meguan
Mescorit
Metbay
Metforal
Metformin (hydrochloride)
Metformin HCL
Metformin HCl ER
Metformin HCl(Glucophage)
Metformin hydrochloride (Glucophage)
Metformin hydrochloride (JP17/USP)
Metformin hydrochloride [USAN:USP:JAN]
Metformin hydrochloride [USAN]
Metformin Hydrochloride 1.0 mg/ml in Methanol (as free base)
Metformin hydrochloride, British Pharmacopoeia (BP) Reference Standard
Metformin hydrochloride, European Pharmacopoeia (EP) Reference Standard
Metformin hydrochloride, pharmaceutical secondary standard; traceable to USP and PhEur
Metformin hydrochloride, United States Pharmacopeia (USP) Reference Standard
Metformin monohydrochloride
Metiguanide monohydrochloride
Metolmin
Metomin
MFCD00012582
MLS000028493
MLS002222221
MolPort-000-771-764
MolPort-039-227-817
N-[amino(dimethylamino)methylidene]guanidine hydrochloride
N,N-Dimethylbiguanide hydrochloride
N,N-dimethylimidodicarbonimidic diamide hydrochloride
N,N-Dimethylimidodicarbonimidic diamine
N',N'-dimethylbiguanide hydrochloride
N1,N1-Dimethylbiguanide hydrochloride
NCGC00016564-01
NCGC00016564-06
NCGC00095185-01
NCGC00095185-02
Novo-Metformin
NSC 91485
NSC-759262
NSC-91485
NSC759262
NSC91485
OETHQSJEHLVLGH-UHFFFAOYSA-N
OR145246
Pharmakon1600-01505814
Prestwick_519
Q-201360
Riomet
Risidon
RP22848
RTR-002281
s1950
SC-17468
SCHEMBL10325580
SCHEMBL22977
Siamformet
SMR000058277
SPECTRUM1505814
ST24048701
SY001217
Thiabet
TL8000340
Tox21_110498
Tox21_110498_1
TR-002281
TRA0069243
UNII-786Z46389E
Walaphage
Z2244578658

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

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
Nostrum Labs Inc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	203832-001	Dec 26, 2017	AB2	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Apotex	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	075984-002	Apr 23, 2002	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Mylan	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	090406-001	Feb 25, 2011	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Barr	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	075971-001	Jan 25, 2002		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

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Expired US Patents for METFORMIN HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	021574-002	Apr 27, 2004	➤ Sign Up	➤ Sign Up
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	➤ Sign Up	➤ Sign Up
Bristol Myers Squibb	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	021574-002	Apr 27, 2004	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Non-Orange Book US Patents for METFORMIN HYDROCHLORIDE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
6,559,187	Liquid formulation of metformin	➤ Sign Up
2,005,182,056		➤ Sign Up
8,128,957	Modified release compositions of at least one form of tramadol	➤ Sign Up
8,158,147	Modified release formulations of at least one form of tramadol	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

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International Patents for METFORMIN HYDROCHLORIDE

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Country	Document Number	Estimated Expiration
South Korea	100716756	➤ Sign Up
Australia	2003211145	➤ Sign Up
Denmark	1476138	➤ Sign Up
Australia	2001239893	➤ Sign Up
Canada	2320900	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0677	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
2012022	Lithuania	➤ Sign Up	PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
2014000071	Germany	➤ Sign Up	PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
00677	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
77; 5006-2008	Slovakia	➤ Sign Up	PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description