You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Mallinckrodt
Moodys
Merck
Colorcon

Last Updated: September 29, 2020

DrugPatentWatch Database Preview

VIRAMUNE XR Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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. Twelve suppliers are listed for this compound. Additional details are available on the nevirapine profile page.

US ANDA Litigation and Generic Entry Outlook for Viramune Xr

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

  Start Trial

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

See drug prices for VIRAMUNE XR

Recent Clinical Trials for VIRAMUNE XR

Identify potential brand extensions & 505(b)(2) entrants

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   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 990022 Netherlands   Start Trial 990022, 20101116, EXPIRES: 20121222
0429987 9990018-5 9991018-4 Sweden   Start Trial 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 C990022 Netherlands   Start Trial 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 18/1999 Austria   Start Trial PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
0429987 SPC/GB99/020 United Kingdom   Start Trial 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 99C0019 France   Start Trial PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Colorcon
Baxter
Johnson and Johnson
Mallinckrodt

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 verification 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.