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-five 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.
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Questions you can ask:
- What is the 5 year forecast for glumetza?
- What are the global sales for glumetza?
- What is Average Wholesale Price for glumetza?
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: | 50 |
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 |
![glumetza drug patent expirations Drug patent expirations by year for glumetza](/p/graph/s/t/glumetza-patent-expirations.png)
![Drug Prices for glumetza](/p/graph/drug-price/glumetza.png)
![Drug Sales Revenue Trends for glumetza](/p/graph/drug-sales-revenues/glumetza.png)
Recent Clinical Trials for glumetza
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Brigham and Women's Hospital | Phase 2 |
Arthritis Foundation | Phase 2 |
University of Colorado, Denver | Phase 1 |
Pharmacology for glumetza
Drug Class | Biguanide |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ 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 | 021748-002 | 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 |
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 |
International Patents for glumetza
See the table below for patents covering glumetza around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2003535886 | ⤷ Sign Up | |
Australia | 729529 | ⤷ Sign Up | |
Japan | 2010155864 | MODIFIED RELEASE PHARMACEUTICAL COMPOSITION OF AT LEAST ONE FORM OF TRAMADOL | ⤷ Sign Up |
Canada | 2476496 | FORMES POSOLOGIQUES A LIBERATION CONTROLEE (CONTROLLED RELEASE DOSAGE FORMS) | ⤷ Sign Up |
Japan | 4083818 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for glumetza
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506211 | C 2014 029 | Romania | ⤷ Sign Up | 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 |
1412357 | CA 2008 00035 | Denmark | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID |
1506211 | 122014000071 | 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 |
1412357 | C 2008 016 | Romania | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408 |
1532149 | CA 2013 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |