glumetza Drug Patent Profile
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Which patents cover Glumetza, and when can generic versions of Glumetza launch?
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. Jude Children's Research Hospital | 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 |
---|---|---|---|
Germany | 69831335 | ⤷ Try a Trial | |
South Korea | 20030023876 | ⤷ Try a Trial | |
Canada | 2409999 | MELANGES DE POLYMERES OPTIQUES POUR DES COMPRIMES POUVANT ETRE RETENUS DANS L'ESTOMAC (OPTICAL POLYMER MIXTURES FOR GASTRIC RETENTIVE TABLETS) | ⤷ Try a Trial |
New Zealand | 523214 | A dosage form of a solid monolithic matrix non-circular in shape having first and second orthoganal axes of unequal length and that swells upon contact with water | ⤷ Try a Trial |
Spain | 2377729 | ⤷ Try a Trial | |
Japan | 2003535886 | ⤷ 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 | DO 77; 5006-2008 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
1532149 | 132013902118390 | Italy | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720 |
2498758 | LUC00152 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113 |
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 |
1506211 | PA2014026,C1506211 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
1506211 | C 2014 029 | Romania | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |