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Last Updated: June 14, 2021

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VIRAMUNE XR Drug Profile


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When do Viramune Xr patents expire, and when can generic versions of Viramune Xr launch?

Viramune Xr 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.

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

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Viramune Xr

A generic version of VIRAMUNE XR was approved as nevirapine by AUROBINDO on May 22nd, 2012.

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Drug patent expirations by year for VIRAMUNE XR
Drug Prices for VIRAMUNE XR

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Recent Clinical Trials for VIRAMUNE XR

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SponsorPhase
Ratiopharm GmbHPhase 1
Ministry of Health, Guinea-BissauPhase 4
Aarhus University Hospital SkejbyPhase 4

See all VIRAMUNE XR clinical trials

Paragraph IV (Patent) Challenges for VIRAMUNE XR
Tradename Dosage Ingredient NDA Submissiondate
VIRAMUNE XR TABLET, EXTENDED RELEASE;ORAL nevirapine 201152 2013-06-21

US Patents and Regulatory Information for VIRAMUNE XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-002 Nov 8, 2012 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VIRAMUNE XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0429987 C990022 Netherlands   Get Started Free PRODUCT 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
0429987 9990018-5 9991018-4 Sweden   Get Started Free PRODUCT NAME: 5,11-DIHYDRO-6H-DIPYRIDO3,2-B:2,3-E1,4DIAZEPINER OCH DERAS ANVAENDNING VID PREVENTION ELLER BEHANDLING AV HIV-INFEKTION; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRTION: LI 54393 19971223
0429987 990022 Netherlands   Get Started Free 990022, 20101116, EXPIRES: 20121222
0429987 99C0021 Belgium   Get Started Free PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223
0429987 99C0019 France   Get Started Free PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223
0429987 SPC/GB99/020 United Kingdom   Get Started Free PRODUCT NAME: NEVIRAPINE = 11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO(3,2-B:2',3'-E)(1,4)DIAZEPIN-6-ONE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: CH 54393 19971223; UK EU/1/97/055/001 19980205
0429987 18/1999 Austria   Get Started Free PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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