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Last Updated: February 29, 2024

Nevirapine - Generic Drug Details


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What are the generic sources for nevirapine and what is the scope of patent protection?

Nevirapine is the generic ingredient in three branded drugs marketed by Aurobindo, Cipla, Boehringer Ingelheim, Alvogen, Apotex, Aurobindo Pharma, Macleods Pharms Ltd, Mylan, Sandoz, Tech Organized, Apotex Inc, Hetero Labs Ltd Iii, Micro Labs Ltd, Mylan Labs, Mylan Pharms Inc, Prinston Inc, and Strides Pharma, and is included in twenty-six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nevirapine has thirty-two patent family members in twenty-seven countries.

There are twenty drug master file entries for nevirapine. Eight suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for nevirapine
Drug Prices for nevirapine

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Recent Clinical Trials for nevirapine

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

SponsorPhase
Johns Hopkins UniversityPhase 1/Phase 2
The Aurum Institute NPCPhase 1/Phase 2
Jean-Pierre RoutyN/A

See all nevirapine clinical trials

Generic filers with tentative approvals for NEVIRAPINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial50MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial200MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial200MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for nevirapine
Paragraph IV (Patent) Challenges for NEVIRAPINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NEVIRAPINE Injection nevirapine 5 mg/vial 203411 1 2016-12-21
VIRAMUNE XR Extended-release Tablets nevirapine 400 mg 201152 3 2013-06-21

US Patents and Regulatory Information for nevirapine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc NEVIRAPINE nevirapine TABLET;ORAL 203021-001 May 22, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tech Organized NEVIRAPINE nevirapine TABLET;ORAL 203176-001 May 22, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-002 Nov 8, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tech Organized NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 207467-002 Jul 31, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipla NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 206448-001 Oct 15, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for nevirapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim VIRAMUNE nevirapine SUSPENSION;ORAL 020933-001 Sep 11, 1998 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim VIRAMUNE nevirapine TABLET;ORAL 020636-001 Jun 21, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for nevirapine

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.
Withdrawn yes no no 2009-11-30
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for nevirapine

Country Patent Number Title Estimated Expiration
Hong Kong 1145806 EXTENDED RELEASE FORMULATION OF NEVIRAPINE ⤷  Try a Trial
Peru 20131035 FORMULACION DE NEVIRAPINA DE LIBERACION PROLONGADA ⤷  Try a Trial
Taiwan I419716 ⤷  Try a Trial
Spain 2574836 ⤷  Try a Trial
European Patent Office 2155169 FORMULATION À LIBÉRATION PROLONGÉE DE NÉVIRAPINE (EXTENDED RELEASE FORMULATION OF NEVIRAPINE) ⤷  Try a Trial
Poland 2155169 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for nevirapine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0429987 99C0019 France ⤷  Try a Trial PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223
0429987 99C0021 Belgium ⤷  Try a Trial PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223
0429987 C990022 Netherlands ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
0429987 SPC/GB99/020 United Kingdom ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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