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Last Updated: May 29, 2023

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. 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.

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Drug patent expirations by year for GLUMETZA
Drug Prices for GLUMETZA

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Drug Sales Revenue Trends for GLUMETZA

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Recent Clinical Trials for GLUMETZA

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SponsorPhase
University of Colorado, DenverPhase 1
National Heart, Lung, and Blood Institute (NHLBI)Phase 1
St. Baldrick's FoundationPhase 2

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Pharmacology for GLUMETZA
Drug ClassBiguanide
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 021748-002 Jun 3, 2005 AB3 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 ⤷  Try a Trial ⤷  Try a Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 ⤷  Try a Trial ⤷  Try a Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 ⤷  Try a Trial ⤷  Try a Trial
>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
Hong Kong 1027298 ⤷  Try a Trial
European Patent Office 1476139 FORMES POSOLOGIQUES À LIBÉRATION CONTROLÉE (CONTROLLED RELEASE DOSAGE FORMS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 0197783 ⤷  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
1506211 CA 2014 00037 Denmark ⤷  Try a Trial PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
2498758 CA 2020 00017 Denmark ⤷  Try a Trial 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
1532149 PA2012022 Lithuania ⤷  Try a Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.