AVANDAMET Drug Patent Profile

When do Avandamet patents expire, and what generic alternatives are available?

Avandamet is a drug marketed by Sb Pharmco and is included in one NDA.

The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.

Summary for AVANDAMET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	14
Patent Applications:	2,652
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVANDAMET
What excipients (inactive ingredients) are in AVANDAMET?	AVANDAMET excipients list
DailyMed Link:	AVANDAMET at DailyMed

Recent Clinical Trials for AVANDAMET

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
M.D. Anderson Cancer Center	Phase 1
Susan G. Komen Breast Cancer Foundation	Phase 1

See all AVANDAMET clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for AVANDAMET

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

A10BG	Thiazolidinediones
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for AVANDAMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVANDAMET	Tablets	metformin hydrochloride; rosiglitazone maleate	1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg	021410	1	2004-10-22

US Patents and Regulatory Information for AVANDAMET

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	021410-004	Aug 25, 2003		DISCN	Yes	No
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002		DISCN	Yes	No
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-005	Aug 25, 2003		DISCN	Yes	No
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-001	Oct 10, 2002		DISCN	Yes	No
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-003	Oct 10, 2002		DISCN	Yes	No

Expired US Patents for AVANDAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-003	Oct 10, 2002
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-005	Aug 25, 2003
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-004	Aug 25, 2003
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-004	Aug 25, 2003
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002

International Patents for AVANDAMET

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

Country	Patent Number	Title	Estimated Expiration
Algeria	3164	Nouvel agent pharmaceutique.
World Intellectual Property Organization (WIPO)	0064893
Slovenia	9300452	SUBSTITUTED THIAZOLIDINEDIONE DERIVATES
Greece	3030794
Eurasian Patent Organization	004878	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ЛЕЧЕНИЯ САХАРНОГО ДИАБЕТА (PHARMACEUTICAL COMPOSITION FOR TREATING DIABETICS)

Supplementary Protection Certificates for AVANDAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
1532149	C300569	Netherlands		PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
2498758	122020000018	Germany		PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111
0861666	SPC 038/2006	Ireland		SPC 038/2006: 20070528, EXPIRES: 20210619