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Last Updated: August 10, 2022

VIRAMUNE XR Drug Patent 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. Ten 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
University of Witwatersrand, South AfricaPhase 4
National Institutes of Health (NIH)Phase 4
Columbia UniversityPhase 4

See all VIRAMUNE XR clinical trials

Paragraph IV (Patent) Challenges for VIRAMUNE XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VIRAMUNE XR Extended-release Tablets nevirapine 400 mg 201152 2013-06-21

US Patents and Regulatory Information for VIRAMUNE XR

VIRAMUNE XR is protected by one US patents.

Patents protecting VIRAMUNE XR

Extended release formulation of nevirapine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for VIRAMUNE XR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Viramune nevirapine EMEA/H/C/000183
Tablets and oral suspensionViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents, and children of any age.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.50- and 100-mg prolonged-release tabletsViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adolescents and children three years and above and able to swallow tablets.Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.400-mg prolonged-release tabletsViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents and children three years and above and able to swallow tablets.Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.
Authorised no no no 1998-02-04
Teva B.V.  Nevirapine Teva nevirapine EMEA/H/C/001119
Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV 1 infected adults, adolescents, and children of any age.Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing.
Authorised yes no no 2009-11-30
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for VIRAMUNE XR

See the table below for patents covering VIRAMUNE XR around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0410148 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazépin-6-ones et -thiones et leur utilisation pour la prévention ou le traitement du SIDA. (Novel 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-ones and thiones and their use in the prevention or treatment of AIDS.) See Plans and Pricing
Ukraine 97971 ПРЕПАРАТ НЕВИРАПИНА ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ;ПРЕПАРАТ НЕВІРАПІНУ ПРОЛОНГОВАНОГО ВИВІЛЬНЕННЯ (EXTENDED RELEASE FORMULATION OF NEVIRAPINE) See Plans and Pricing
African Regional IP Organization (ARIPO) 189 5,11 Dihydro-6H-dipyrido (3,2-b:2, 3 -e)(1,4)-diazepin-6-ones and thions and their use for the treatment of aids. See Plans and Pricing
African Regional IP Organization (ARIPO) 9000224 See Plans and Pricing
Poland 2155169 See Plans and Pricing
Russian Federation 2024522 DERIVATIVES OF DIPYRIDO-DIAZEPINE AND THEIR PHARMACOLOGICALLY TOLERATED SALTS SHOWING BIOLOGICAL ACTIVITY See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIRAMUNE XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0429987 SPC/GB99/020 United Kingdom See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223
0429987 99C0021 Belgium See Plans and Pricing PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223
0429987 990022 Netherlands See Plans and Pricing 990022, 20101116, EXPIRES: 20121222
0429987 9990018-5 9991018-4 Sweden See Plans and Pricing 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 18/1999 Austria See Plans and Pricing 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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