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METFORMIN HYDROCHLORIDE - Generic Drug Details
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, Alkem Labs Ltd, 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, Novast Labs, Prinston Inc, Ranbaxy Labs Ltd, Sandoz, Sun Pharm Inds (in), Sun Pharm Industries, Sun Pharma Global, Teva, Torrent Pharms Ltd, Watson Labs Inc, Yichang Humanwell, Zydus Pharms Usa, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell Life Sci, Dr Reddys Labs Inc, Glenmark Generics, Granules India, 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, Takeda Pharms Usa, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, and Merck Sharp Dohme, and is included in one hundred and one 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-nine drug master file entries for metformin hydrochloride. One hundred and twelve 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: | 62 |
| NDAs: | 101 |
| Drug Master File Entries: | 49 |
| Suppliers / Packagers: | 112 |
| Bulk Api Vendors: | 122 |
| Clinical Trials: | 2,037 |
| 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
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Macleods Pharms Ltd | METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET;ORAL | 205330-003 | Oct 31, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Bristol Myers Squibb | GLUCOPHAGE | metformin hydrochloride | TABLET;ORAL | 020357-004 | Nov 5, 1998 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Barr | METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 076863-001 | Oct 14, 2004 | 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 |
Expired US Patents for METFORMIN HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | 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 |
International Patents for METFORMIN HYDROCHLORIDE
Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1532149 | C300569 | Netherlands | ➤ Sign Up | PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720 |
| 1412357 | 50/2008 | Austria | ➤ Sign Up | PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408 |
| 1261586 | C300524 | Netherlands | ➤ Sign Up | PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION: |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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