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VIRAMUNE XR Drug Profile

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Viramune Xr 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.

This drug has thirty patent family members in twenty-seven countries.

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 seven tentative approvals for this compound. Additional details are available on the nevirapine profile page.

Summary for Tradename: VIRAMUNE XR

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list78
Clinical Trials: see list1
Patent Applications: see list6,025
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VIRAMUNE XR at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
VIRAMUNE XR
nevirapine
TABLET, EXTENDED RELEASE;ORAL201152-002Nov 8, 2012RXNo► subscribe► subscribe
Boehringer Ingelheim
VIRAMUNE XR
nevirapine
TABLET, EXTENDED RELEASE;ORAL201152-001Mar 25, 2011RXYes8,460,704► subscribe ► subscribe
Boehringer Ingelheim
VIRAMUNE XR
nevirapine
TABLET, EXTENDED RELEASE;ORAL201152-001Mar 25, 2011RXYes► subscribe► subscribe
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Expired Patents for Tradename: VIRAMUNE XR

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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Paragraph IV activity for: VIRAMUNE XR

Drugname Dosage Strength RLD Submissiondate
nevirapineExtended-release Tablets400 mgViramune XR6/21/2013

International Patent Family for Tradename: VIRAMUNE XR

Country Document Number Estimated Expiration
Canada2687491► subscribe
New Zealand578664► subscribe
Peru03712009► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VIRAMUNE XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/1999Austria► subscribePRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
90022Netherlands► subscribePRODUCT NAME: NEVIRAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION: CH 54393 19971223
C0021Belgium► subscribePRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223
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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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