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 24^th, 2002.

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Summary for GLUMETZA

International Patents:	26
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	160
Clinical Trials:	49
Patent Applications:	897
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

Drug patent expirations by year for GLUMETZA

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. Baldrick's Foundation	Phase 2

See all GLUMETZA clinical trials

Pharmacology for GLUMETZA

Drug Class	Biguanide

Anatomical Therapeutic Chemical (ATC) Classes for GLUMETZA

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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

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Glossary

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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

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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.

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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

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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