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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. It is available from three suppliers. 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. Nineteen suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the nevirapine profile page.

Summary for NDA: 201152

Tradename:
VIRAMUNE XR
Applicant:
Boehringer Ingelheim
Ingredient:
nevirapine
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 201152

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIRAMUNE XR
nevirapine
TABLET, EXTENDED RELEASE;ORAL 201152 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0123 0597-0123-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0123-03)
VIRAMUNE XR
nevirapine
TABLET, EXTENDED RELEASE;ORAL 201152 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0123 0597-0123-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0123-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Mar 25, 2011TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Nov 8, 2015
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:8,460,704Patent Expiration:Mar 12, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Nov 8, 2012TE:ABRLD:No
Regulatory Exclusivity Expiration:Nov 8, 2015
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired Orange Book Patents for NDA: 201152

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
VIRAMUNE XR
nevirapine
TABLET, EXTENDED RELEASE;ORAL201152-001Mar 25, 20115,366,972*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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