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Last Updated: June 13, 2024

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.

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Drug patent expirations by year for GLUMETZA
Drug Prices for GLUMETZA

See drug prices for GLUMETZA

Drug Sales Revenue Trends for GLUMETZA

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Recent Clinical Trials for GLUMETZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Colorado, DenverPhase 1
National Heart, Lung, and Blood Institute (NHLBI)Phase 1
St. Jude Children's Research HospitalPhase 2

See all GLUMETZA clinical trials

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 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 021748-001 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
Austria 536863 ⤷  Sign Up
Japan 2009040787 TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM ⤷  Sign Up
Japan 5133495 ⤷  Sign Up
Denmark 1294363 ⤷  Sign Up
Germany 60101581 ⤷  Sign Up
South Korea 20030023876 ⤷  Sign Up
Japan 2013224324 TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GLUMETZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1506211 300677 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1506211 CR 2014 00037 Denmark ⤷  Sign Up 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
1412357 50/2008 Austria ⤷  Sign Up PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
1532149 132013902118390 Italy ⤷  Sign Up 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
1261586 132012902044560 Italy ⤷  Sign Up PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
1506211 PA2014026,C1506211 Lithuania ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
>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.