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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 seventeen branded drugs marketed by Sun Pharm, Sun Pharm Inds Ltd, Andrx Labs Llc, Emd Serono Inc, Santarus Inc, Actavis Elizabeth, Actavis Labs Fl Inc, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cadila, Cspc Ouyi, Granules India Ltd, Impax Labs, Intellipharmaceutics, Inventia, Ivax Sub Teva Pharms, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Mylan, Mylan Pharms Inc, Nostrum Labs Inc, Nostrum Pharms Llc, Novast Labs, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Sandoz, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Watson Labs Inc, Yichang Humanwell, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell Life Sci, Dr Reddys Labs Inc, Glenmark Generics, Granules India, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Laurus Labs Ltd, Provident Pharm, Sciegen Pharms Inc, Sun Pharm Inds Inc, Sunshine Lake, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Zydus Pharms Usa, Takeda Pharms Usa, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, and Merck Sharp Dohme, and is included in one hundred and three NDAs. There are twenty-six 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 eighteen patent family members in twenty-eight countries.
There are forty-nine drug master file entries for metformin hydrochloride. Ninety-eight suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for metformin hydrochloride
International Patents: | 118 |
US Patents: | 26 |
Tradenames: | 17 |
Applicants: | 66 |
NDAs: | 103 |
Drug Master File Entries: | 49 |
Suppliers / Packagers: | 98 |
Bulk Api Vendors: | 123 |
Clinical Trials: | 2,129 |
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 |
Recent Clinical Trials for metformin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Emory University | Phase 2/Phase 3 |
University of Rochester | Phase 2/Phase 3 |
Louisiana State University Health Sciences Center in New Orleans | Phase 2/Phase 3 |
Recent Litigation for metformin hydrochloride
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
BAUSCH HEALTH IRELAND LIMITED v. APOTEX INC. | 2019-06-28 |
SUN PHARMACEUTICAL INDUSTRIES LTD. v. VISTAPHARM, INC. | 2019-03-01 |
Shionogi Inc. v. Amneal Pharmaceuticals, LLC | 2018-10-11 |
See all metformin hydrochloride litigation
PTAB Litigation
Petitioner | Date |
---|---|
Aurobindo Pharma USA Inc. | 2018-01-24 |
Aurobindo Pharma USA Inc. | 2017-06-23 |
Aurobindo Pharma USA Inc. | 2017-06-22 |
Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 500MG | TABLET, EXTENDED RELEASE;ORAL |
Start Trial | Start Trial | 1GM; EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL |
Start Trial | Start Trial | 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
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 |
BC206669 |
BCP03594 |
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 |
Diabetosan |
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 solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material |
Metformin hydrochloride, British Pharmacopoeia (BP) Reference Standard |
Metformin hydrochloride, European Pharmacopoeia (EP) Reference Standard |
Metformin hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material |
Metformin hydrochloride, pharmaceutical secondary standard; traceable to USP and PhEur |
Metformin hydrochloride, United States Pharmacopeia (USP) Reference Standard |
Metformin Hydrochloride,(S) |
Metformin monohydrochloride |
Metformin, HCl |
Metiguanide monohydrochloride |
Metolmin |
Metomin |
MFCD00012582 |
MFCD00012582 (97+%) |
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 |
OR322044 |
Pharmakon1600-01505814 |
Prestwick_519 |
Q-201360 |
Riomet |
Risidon |
RP22848 |
RTR-002281 |
s1950 |
SB19704 |
SC-17468 |
SCHEMBL10325580 |
SCHEMBL20140191 |
SCHEMBL22977 |
Siamformet |
SMR000058277 |
SPECTRUM1505814 |
SR-05000001764-2 |
ST24048701 |
SY001217 |
Thiabet |
TL8000340 |
Tox21_110498 |
Tox21_110498_1 |
TR-002281 |
TRA0069243 |
UNII-786Z46389E |
Walaphage |
Z2244578658 |
Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
RIOMET | SOLUTION;ORAL | metformin hydrochloride | 021591 | 2018-02-02 |
GLUMETZA | TABLET, EXTENDED RELEASE;ORAL | metformin hydrochloride | 021748 | 2009-07-27 |
FORTAMET | TABLET, EXTENDED RELEASE;ORAL | metformin hydrochloride | 021574 | 2008-10-14 |
GLUCOPHAGE XR | TABLET, EXTENDED RELEASE;ORAL | metformin hydrochloride | 021202 |
US Patents and Regulatory Information for metformin hydrochloride
Expired US Patents for metformin hydrochloride
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 | Start Trial | Start Trial |
Emd Serono Inc | GLUCOPHAGE XR | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021202-001 | Oct 13, 2000 | Start Trial | Start Trial |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | Start Trial | Start Trial |
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-001 | Apr 27, 2004 | Start Trial | Start Trial |
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-002 | Apr 27, 2004 | Start Trial | Start Trial |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for metformin hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
South Korea | 20030023876 | Start Trial |
Japan | 2007535557 | Start Trial |
Mexico | PA04008164 | Start Trial |
Australia | 2015254875 | Start Trial |
Australia | 3083002 | Start Trial |
European Patent Office | 1335708 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for metformin hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506211 | 179 5017-2014 | Slovakia | Start Trial | 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 |
1506211 | 300677 | Netherlands | Start Trial | 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 |
1412357 | C300357 | Netherlands | Start Trial | PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
1412357 | 122008000046 | Germany | Start Trial | 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 | 42/2014 | Austria | Start Trial | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121 |
1412357 | 77 5006-2008 | Slovakia | Start Trial | PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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