GLUMETZA Drug Patent Profile

Which patents cover Glumetza, and when can generic versions of Glumetza launch?

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 24^th, 2002.

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:	49
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

See drug prices for GLUMETZA

See drug sales revenues for GLUMETZA

Recent Clinical Trials for GLUMETZA

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1
University of Colorado, Denver	Phase 1
St. Jude Children's Research Hospital	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 one US patents.

Patents protecting GLUMETZA

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			Y	Y
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	AB3	RX	Yes	No

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
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005

International Patents for GLUMETZA

See the table below for patents covering GLUMETZA around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	PA04008164	FORMAS DE DOSIFICACION DE LIBERACION CONTROLADA. (CONTROLLED RELEASE DOSAGE FORMS.)
Japan	2009040787	TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM
Japan	2005526047
Spain	2377729

Supplementary Protection Certificates for GLUMETZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C300357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1506211	42/2014	Austria		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1506211	SPC/GB14/050	United Kingdom		PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
1412357	C 2008 016	Romania		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