DrugPatentWatch Database Preview
GLUMETZA Drug Profile
When do Glumetza patents expire, and what generic alternatives are available?
Glumetza is a drug marketed by Santarus Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-six patent family members in eighteen countries.
The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-nine drug master file entries for this compound. One hundred and thirteen 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: | 54 |
| Clinical Trials: | 42 |
| Patent Applications: | 6,664 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GLUMETZA |
| Drug Sales Revenues: | Drug sales revenues for GLUMETZA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GLUMETZA |
| Prior Art and Litigation Support | Order Prior Art and Litigation support for GLUMETZA |
| DailyMed Link: | GLUMETZA at DailyMed |
Pharmacology for GLUMETZA
| 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 |
| 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 |
| DB00331 |
| Diabex |
| Dianben |
| Dimethylbiguanid |
| Dimethylbiguanide |
| Dimethyldiguanide |
| Dimethylguanylguanidine |
| DMBG |
| DMGG |
| DSSTox_CID_3270 |
| DSSTox_GSID_23270 |
| DSSTox_RID_76950 |
| DTXSID2023270 |
| EINECS 211-517-8 |
| Fluamine |
| Flumamine |
| Fortamet |
| FT-0628266 |
| Gen-Metformin |
| Glifage |
| Gliguanid |
| Glucophage |
| Glucophage (Salt/Mix) |
| 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 |
| Mylan-Metformin |
| N-dimethylbiguanide |
| N,N-Dimethylbiguanide |
| N,N-Dimethyldiguanide |
| N,N-Dimethylguanylguanidin |
| 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 |
| PMS-Metformin |
| Prestwick0_000004 |
| Prestwick1_000004 |
| Prestwick2_000004 |
| Prestwick3_000004 |
| Ran-Metformin |
| Ratio-Metformin |
| Sandoz Metformin |
| SBI-0206876.P001 |
| SC-73311 |
| SCHEMBL10276396 |
| SCHEMBL8944 |
| SCHEMBL9913821 |
| Siofor |
| SMR000058277 |
| SPBio_001928 |
| STK011633 |
| STL483693 |
| STL484070 |
| 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 | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | AB3 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | AB3 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | AB3 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | |
| 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 | 021748-002 | Jun 3, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for GLUMETZA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 500 mg and 1000 mg | ➤ Subscribe | ➤ Try a Free Trial |
International Patents for GLUMETZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1476138 | ➤ Try a Free Trial |
| Cyprus | 1112517 | ➤ Try a Free Trial |
| Spain | 2377729 | ➤ Try a Free Trial |
| Spain | 2213108 | ➤ Try a Free Trial |
| Japan | 5133495 | ➤ Try a Free Trial |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for GLUMETZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1532149 | 92128 | Luxembourg | ➤ Try a Free Trial | 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 |
| 1412357 | PA2008013 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716 |
| 1506211 | 179 5017-2014 | Slovakia | ➤ Try a Free 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 | PA2014026 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| 1730131 | C01730131/02 | Switzerland | ➤ Try a Free Trial | PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
