Details for New Drug Application (NDA): 201152

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NDA 201152 describes VIRAMUNE XR, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the VIRAMUNE XR profile page.

The generic ingredient in VIRAMUNE XR is nevirapine. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the nevirapine profile page.

Summary for 201152

Tradename:	VIRAMUNE XR
Applicant:	Boehringer Ingelheim
Ingredient:	nevirapine
Patents:	1

Medical Subject Heading (MeSH) Categories for 201152

Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	400MG
Approval Date:	Mar 25, 2011	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 12, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Nov 8, 2012	TE:		RLD:	Yes

Expired US Patents for NDA 201152

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	VIRAMUNE XR	nevirapine	TABLET, EXTENDED RELEASE;ORAL	201152-001	Mar 25, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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