DrugPatentWatch Database Preview
GLUMETZA Drug Profile
When do Glumetza patents expire, and what generic alternatives are available?
This drug has fifty-six patent family members in eighteen countries.
The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-eight drug master file entries for this compound. One hundred and twelve suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for GLUMETZA
| International Patents: | 56 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 53 |
| Clinical Trials: | 39 |
| Patent Applications: | 4,438 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | GLUMETZA at DailyMed |
Pharmacology for GLUMETZA
| Ingredient-type | Biguanides |
| Drug Class | Biguanide |
Medical Subject Heading (MeSH) Categories for GLUMETZA
Synonyms for GLUMETZA
| [14C]-metformin |
| [14C]metformin |
| {[amino(dimethylamino)methylidene]amino}methanimidamide |
| 1-[(diaminomethylidene)amino]-N,N-dimethylmethanimidamide |
| 1-[(E)-amino(dimethylamino)methylidene]guanidine |
| 1-carbamimidamido-N,N-dimethylmethanimidamide |
| 1,1-Dimethyl biguanide |
| 1,1-Dimethylbiguanide |
| 15673-EP2269977A2 |
| 15673-EP2269989A1 |
| 15673-EP2270007A1 |
| 15673-EP2270011A1 |
| 15673-EP2272825A2 |
| 15673-EP2272834A1 |
| 15673-EP2272841A1 |
| 15673-EP2275108A1 |
| 15673-EP2275414A1 |
| 15673-EP2280001A1 |
| 15673-EP2287165A2 |
| 15673-EP2287166A2 |
| 15673-EP2292228A1 |
| 15673-EP2292620A2 |
| 15673-EP2295406A1 |
| 15673-EP2295409A1 |
| 15673-EP2295411A1 |
| 15673-EP2295422A2 |
| 15673-EP2298742A1 |
| 15673-EP2298769A1 |
| 15673-EP2298772A1 |
| 15673-EP2298776A1 |
| 15673-EP2298779A1 |
| 15673-EP2301533A1 |
| 15673-EP2301923A1 |
| 15673-EP2301929A1 |
| 15673-EP2301935A1 |
| 15673-EP2301936A1 |
| 15673-EP2305648A1 |
| 15673-EP2305674A1 |
| 15673-EP2308839A1 |
| 15673-EP2308847A1 |
| 15673-EP2308878A2 |
| 15673-EP2314576A1 |
| 15673-EP2314588A1 |
| 15673-EP2316470A2 |
| 3-(diaminomethylene)-1,1-dimethyl-guanidine |
| 3-(diaminomethylene)-1,1-dimethyl-guanidine;hydrochloride |
| 3-(diaminomethylidene)-1,1-dimethylguanidine |
| 3-(diaminomethylidene)-1,1-dimethylguanidine;hydrochloride |
| 3-[bis(azanyl)methylidene]-1,1-dimethyl-guanidine;hydrochloride |
| 3-carbamimidoyl-1,1-dimethyl-guanidine |
| 657-24-9 |
| 657M249 |
| 9100L32L2N |
| A19551 |
| AB2000590 |
| AC1L1HE4 |
| AK310686 |
| AKOS000121065 |
| AKOS005206848 |
| AKOS015966566 |
| AN-47122 |
| BBL012337 |
| BDBM50229665 |
| BDBM57047 |
| BIDD:GT0697 |
| BIGUANIDE, 1,1-DIMETHYL- |
| BPBio1_000009 |
| BRD-K79602928-003-04-1 |
| BRD-K79602928-003-08-2 |
| BSPBio_000007 |
| BSPBio_002314 |
| C07151 |
| C4H11N5 |
| CAS-1115-70-4 |
| CAS-657-24-9 |
| CCG-102605 |
| CCRIS 9321 |
| CHEBI:6801 |
| CHEMBL1431 |
| cid_14219 |
| cMAP_000016 |
| CTK2F2882 |
| D04966 |
| D09AYI |
| D0D7LA |
| DB00331 |
| Diabetosan |
| Diabex |
| Diabex (TN) |
| Diaformin (TN) |
| Diamin |
| Dianben |
| Dianben (TN) |
| Dimethylbiguanid |
| Dimethylbiguanide |
| Dimethylbiguanidine |
| Dimethyldiguanide |
| Dimethylguanylguanidine |
| DMBG |
| DMGG |
| DSSTox_CID_3270 |
| DSSTox_GSID_23270 |
| DSSTox_RID_76950 |
| DTXSID2023270 |
| EINECS 211-517-8 |
| Fluamine |
| Flumamine |
| Fortamet |
| Fortamet (TN) |
| FT-0628266 |
| Gen-Metformin |
| Glifage |
| Gliguanid |
| Glucophage |
| Glucophage (Salt/Mix) |
| Glucophage (TN) |
| Glumetza (TN) |
| Glycon |
| GTPL4503 |
| GTPL4779 |
| Haurymelin |
| HMS2089D19 |
| HSCI1_000295 |
| Imidodicarbonimidic diamide-, N,N-dimethyl- |
| Imidodicarbonimidic diamide, N,N-dimethyl- |
| Imidodicarbonimidicdiamide, N,N-dimethyl- |
| Islotin |
| K070 |
| KBio2_002310 |
| KBio2_004878 |
| KBio2_007446 |
| KBio3_002790 |
| KBioGR_002310 |
| KBioSS_002312 |
| LA 6023 (Salt/Mix) |
| LA-6023 |
| LS-43899 |
| MCULE-7393156510 |
| Melbin |
| metformin |
| Metformin (USAN/INN) |
| Metformin [USAN:INN:BAN] |
| Metformin base |
| Metformina |
| Metformina [DCIT] |
| Metformina [Spanish] |
| Metformine |
| Metformine [INN-French] |
| Metforminum |
| Metforminum [INN-Latin] |
| Metiguanide |
| MF8 |
| MLS000028493 |
| MolPort-002-929-560 |
| MolPort-005-767-418 |
| MolPort-006-112-103 |
| Mylan-Metformin |
| N-dimethylbiguanide |
| N-OCTYL L-2-PYRROLIDI-5-CARBOXYLATE |
| N,N-Dimethylbiguanide |
| N,N-Dimethyldiguanide |
| N,N-Dimethylguanylguanidin |
| N,N-dimethylguanylguanidine |
| N,N-dimethylimidodicarbonimidic diamide |
| n',n'-dimethylbiguanide |
| N1,N1-Dimethylbiguanide |
| NCGC00016564-01 |
| NCGC00016564-02 |
| NCGC00016564-03 |
| NCGC00016564-05 |
| NCGC00016564-07 |
| NCGC00188959-01 |
| NCGC00255255-01 |
| NNDG |
| Nu-Metformin |
| Obimet |
| Obimet (TN) |
| OR000602 |
| OR026300 |
| OR273467 |
| OR300308 |
| OR321414 |
| PMS-Metformin |
| Prestwick0_000004 |
| Prestwick1_000004 |
| Prestwick2_000004 |
| Prestwick3_000004 |
| Ran-Metformin |
| Ratio-Metformin |
| Riomet (TN) |
| Sandoz Metformin |
| SBI-0206876.P001 |
| SC-73311 |
| SCHEMBL10276396 |
| SCHEMBL8944 |
| SCHEMBL9913821 |
| Siofor |
| SMR000058277 |
| SPBio_001928 |
| STK011633 |
| STL483693 |
| STL484070 |
| T5895664 |
| Teva-Metformin |
| Tox21_302370 |
| UNII-9100L32L2N |
| W-109589 |
| XZWYZXLIPXDOLR-UHFFFAOYSA-N |
| ZINC12859773 |
US Patents and Regulatory Information for GLUMETZA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | AB3 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | AB3 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | AB3 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | AB3 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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 GLUMETZA
| 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 |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | ➤ 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 |
Paragraph IV (Patent) Challenges for GLUMETZA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 500 mg and 1000 mg | ➤ Subscribe | 2009-07-27 |
Non-Orange Book US Patents for GLUMETZA
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.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,158,147 | Modified release formulations of at least one form of tramadol | ➤ Sign Up |
| 2,005,182,056 | ➤ Sign Up | |
| 8,128,957 | Modified release compositions of at least one form of tramadol | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for GLUMETZA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Canada | 2476201 | ➤ Sign Up |
| Portugal | 1294363 | ➤ Sign Up |
| South Korea | 100716756 | ➤ Sign Up |
| European Patent Office | 1476139 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for GLUMETZA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 90013-0 | Sweden | ➤ Sign Up | PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124 |
| 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 |
| 5006-2008 | Slovakia | ➤ Sign Up | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
