AVANDARYL Drug Patent Profile

Which patents cover Avandaryl, and what generic alternatives are available?

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

The generic ingredient in AVANDARYL is glimepiride; rosiglitazone maleate. There are sixteen drug master file entries for this compound. Additional details are available on the glimepiride; rosiglitazone maleate profile page.

Summary for AVANDARYL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	1
Patent Applications:	4,024
Formulation / Manufacturing:	see details
DailyMed Link:	AVANDARYL at DailyMed

Recent Clinical Trials for AVANDARYL

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

Sponsor	Phase
GlaxoSmithKline	Phase 3

See all AVANDARYL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for AVANDARYL

A10BB	Sulfonylureas
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 AVANDARYL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVANDARYL	Tablets	glimepiride; rosiglitazone maleate	8 mg/2 mg 8 mg/4 mg	021700	1	2008-05-30
AVANDARYL	Tablets	glimepiride; rosiglitazone maleate	1 mg/4 mg 2 mg/4 mg 4 mg/4 mg	021700	1	2006-12-22

US Patents and Regulatory Information for AVANDARYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-001	Nov 23, 2005		DISCN	Yes	No
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-003	Nov 23, 2005		DISCN	Yes	No
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005		DISCN	Yes	No
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-004	Mar 30, 2007		DISCN	Yes	No
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-005	Mar 30, 2007		DISCN	Yes	No

Expired US Patents for AVANDARYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-001	Nov 23, 2005
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-001	Nov 23, 2005
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-005	Mar 30, 2007

International Patents for AVANDARYL

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	138673	NOVEL PHARMACEUTICAL
Germany	10199003
Netherlands	300034
Eurasian Patent Organization	003031	НОВЫЙ ФАРМАЦЕВТИЧЕСКИЙ ПРЕПАРАТ (THIAZOLIDINEDIONE DERIVATIVE AND ITS USE AS ANTIDIABETIC)
Australia	2755102

Supplementary Protection Certificates for AVANDARYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0306228	2001C/004	Belgium		PRODUCT NAME: ROSIGLITAZONE; REGISTRATION NO/DATE: EU/1/00/137/001 20000717
0658161	CA 2001 00001	Denmark
0306228	SPC/GB01/002	United Kingdom		PRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
0306228	C300034	Netherlands		PRODUCT NAME: ROSIGLITAZONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT, IN HET BIJZONDER ROSIGLITAZONE MALEAAT; REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711
0306228	38/2000	Austria		PRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929