glumetza Drug Patent Profile
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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 is one patent protecting this drug and one Paragraph IV challenge.
This drug has twenty-six patent family members in fourteen countries.
The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Glumetza
A generic version of glumetza was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24th, 2002.
Summary for glumetza
International Patents: | 26 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 164 |
Clinical Trials: | 49 |
Patent Applications: | 579 |
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 |
What excipients (inactive ingredients) are in glumetza? | glumetza excipients list |
DailyMed Link: | glumetza at DailyMed |
Recent Clinical Trials for glumetza
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Colorado, Denver | Phase 1 |
National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 |
St. Baldrick's Foundation | Phase 2 |
Pharmacology for glumetza
Drug Class | Biguanide |
Anatomical Therapeutic Chemical (ATC) Classes for glumetza
Paragraph IV (Patent) Challenges for GLUMETZA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
GLUMETZA | Extended-release Tablets | metformin hydrochloride | 500 mg and 1000 mg | 021748 | 1 | 2009-07-27 |
US Patents and Regulatory Information for glumetza
glumetza is protected by one US patents.
Patents protecting glumetza
Controlled release dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | AB3 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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
International Patents for glumetza
See the table below for patents covering glumetza around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 8138698 | ⤷ Try a Trial | |
Austria | 536863 | ⤷ Try a Trial | |
Spain | 2377729 | ⤷ Try a Trial | |
European Patent Office | 0998271 | FORMES DE DOSAGE DE MEDICAMENTS ADMINISTRES PAR VOIE ORALE A RETENTION GASTRIQUE POUR LIBERATION LENTE DE MEDICAMENTS HAUTEMENT SOLUBLES (GASTRIC-RETENTIVE ORAL DRUG DOSAGE FORMS FOR CONTROLLED RELEASE OF HIGHLY SOLUBLE DRUGS) | ⤷ Try a Trial |
Spain | 2627842 | ⤷ Try a Trial | |
Mexico | PA04003793 | MEZCLAS OPTIMAS DE POLIMEROS PARA TABLETAS RETENTIVAS GASTRICAS. (OPTIMAL POLYMER MIXTURES FOR GASTRIC RETENTIVE TABLETS.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for glumetza
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1412357 | PA2008013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716 |
1532149 | 92128 | Luxembourg | ⤷ Try a 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 |
1730131 | C01730131/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015 |
1412357 | C300357 | Netherlands | ⤷ Try a 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 |
1506211 | 92496 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1 |
2498758 | 122020000018 | Germany | ⤷ Try a Trial | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |