GLUCOPHAGE XR Drug Patent Profile

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

Glucophage Xr is a drug marketed by Emd Serono Inc and is included in one NDA.

The generic ingredient in GLUCOPHAGE XR is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glucophage Xr

A generic version of GLUCOPHAGE XR was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24^th, 2002.

Summary for GLUCOPHAGE XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	350
Patent Applications:	579
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GLUCOPHAGE XR
DailyMed Link:	GLUCOPHAGE XR at DailyMed

See drug prices for GLUCOPHAGE XR

Recent Clinical Trials for GLUCOPHAGE XR

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

Sponsor	Phase
United States Department of Defense	Phase 1
James Wang	Phase 1
Aga Khan University	Phase 1

See all GLUCOPHAGE XR clinical trials

US Patents and Regulatory Information for GLUCOPHAGE XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-001	Oct 13, 2000		DISCN	Yes	No
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003		DISCN	Yes	No

Expired US Patents for GLUCOPHAGE XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-001	Oct 13, 2000
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003

International Patents for GLUCOPHAGE XR

See the table below for patents covering GLUCOPHAGE XR around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	003101	ДВУХФАЗНАЯ СИСТЕМА ДОСТАВКИ С РЕГУЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ ДЛЯ ФАРМАЦЕВТИЧЕСКИХ СРЕДСТВ С ВЫСОКОЙ РАСТВОРИМОСТЬЮ И СПОСОБ ЛЕЧЕНИЯ ДИАБЕТА С ПОМОЩЬЮ ЭТОЙ СИСТЕМЫ (BIPHASIC CONTROLLED RELEASE DELIVERY SYSTEM FOR HIGH SOLUBILITY PHARMACEUTICALS AND METHOD)
Eurasian Patent Organization	200000968
Indonesia	26082

Supplementary Protection Certificates for GLUCOPHAGE XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	PA2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1532149	92128	Luxembourg		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
1506211	C 2014 029	Romania		PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116