DrugPatentWatch Database Preview

Metformin hydrochloride; rosiglitazone maleate - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for metformin hydrochloride; rosiglitazone maleate and what is the scope of freedom to operate?

Metformin hydrochloride; rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Sb Pharmco and Teva, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; rosiglitazone maleate has sixty-eight patent family members in forty-four countries.

There are forty-nine drug master file entries for metformin hydrochloride; rosiglitazone maleate.

Summary for metformin hydrochloride; rosiglitazone maleate

International Patents:	68
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	49
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metformin hydrochloride; rosiglitazone maleate
DailyMed Link:	metformin hydrochloride; rosiglitazone maleate at DailyMed

Recent Clinical Trials for metformin hydrochloride; rosiglitazone maleate

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
Daiichi Sankyo Inc.	Phase 3
GlaxoSmithKline	Phase 3

See all metformin hydrochloride; rosiglitazone maleate clinical trials

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
AVANDAMET	TABLET;ORAL	metformin hydrochloride; rosiglitazone maleate	021410	2004-10-22

US Patents and Regulatory Information for metformin hydrochloride; rosiglitazone maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002		DISCN	Yes	No			Y
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-003	Oct 10, 2002		DISCN	Yes	No			Y
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-005	Aug 25, 2003		DISCN	Yes	No			Y

Expired US Patents for metformin hydrochloride; rosiglitazone maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-003	Oct 10, 2002
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-004	Aug 25, 2003

International Patents for metformin hydrochloride; rosiglitazone maleate

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	004878
Slovakia	286985
Austria	292466

Supplementary Protection Certificates for metformin hydrochloride; rosiglitazone maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	C01261586/02	Switzerland		PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1412357	77 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408