GLIMEPIRIDE; ROSIGLITAZONE MALEATE - Generic Drug Details

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

Glimepiride; rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Sb Pharmco and Teva Pharms Usa, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Sponsor	Phase
GlaxoSmithKline	Phase 3
Canadian Heart Research Centre	Phase 3

Sponsor

Phase

GlaxoSmithKline

Phase 3

Canadian Heart Research Centre

Phase 3

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

Tradename

Dosage

Ingredient

Strength

NDA

ANDAs Submitted

Submissiondate

AVANDARYL

Tablets

glimepiride; rosiglitazone maleate

8 mg/2 mg 8 mg/4 mg

021700

2008-05-30

AVANDARYL

Tablets

glimepiride; rosiglitazone maleate

1 mg/4 mg 2 mg/4 mg 4 mg/4 mg

021700

2006-12-22

US Patents and Regulatory Information for GLIMEPIRIDE; ROSIGLITAZONE MALEATE

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Glossary

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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	021700-003	Nov 23, 2005		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	ROSIGLITAZONE MALEATE AND GLIMEPIRIDE	glimepiride; rosiglitazone maleate	TABLET;ORAL	078709-003	Apr 1, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	ROSIGLITAZONE MALEATE AND GLIMEPIRIDE	glimepiride; rosiglitazone maleate	TABLET;ORAL	078709-001	Apr 1, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	ROSIGLITAZONE MALEATE AND GLIMEPIRIDE	glimepiride; rosiglitazone maleate	TABLET;ORAL	078709-005	Apr 1, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-004	Mar 30, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-001	Nov 23, 2005		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-005	Mar 30, 2007	⤷ Sign Up	⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-005	Mar 30, 2007	⤷ Sign Up	⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-001	Nov 23, 2005	⤷ Sign Up	⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005	⤷ Sign Up	⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005	⤷ Sign Up	⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-004	Mar 30, 2007	⤷ Sign Up	⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-004	Mar 30, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Applicant

Tradename

Generic Name

Dosage

NDA

Approval Date

Patent No.

Patent Expiration

Sb Pharmco

AVANDARYL

glimepiride; rosiglitazone maleate

TABLET;ORAL