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 are two patents 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. Seventy-nine 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: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 49 |
Patent Applications: | 4,443 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
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 two US patents.
Patents protecting GLUMETZA
Controlled release dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Controlled release dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | AB3 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | AB3 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | See Plans and Pricing | See Plans and Pricing |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | See Plans and Pricing | See Plans and Pricing |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | See Plans and Pricing | See Plans and Pricing |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | See Plans and Pricing | See Plans and Pricing |
>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 | 2005526043 | See Plans and Pricing | |
Japan | 5069395 | See Plans and Pricing | |
Austria | 256455 | See Plans and Pricing | |
Australia | 3989301 | See Plans and Pricing | |
Mexico | PA04008100 | FORMULACIONES DE LIBERACION MODIFICADA DE AL MENOS UNA FORMA DE TRAMADOL. (MODIFIED RELEASE FORMULATIONS OF AT LEAST ONE FORM OF TRAMADOL.) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GLUMETZA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2498758 | 2090013-0 | Sweden | See Plans and Pricing | PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113 |
1261586 | 12C0028 | France | See Plans and Pricing | PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124 |
1261586 | 15/2012 | Austria | See Plans and Pricing | PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124 |
1412357 | DO 77; 5006-2008 | Slovakia | See Plans and Pricing | PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
2498758 | CA 2020 00017 | Denmark | See Plans and Pricing | PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |