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Last Updated: October 6, 2022

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 Ltd, Macleods Pharms Ltd, Mylan, Sandoz Inc, 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-three patent family members in twenty-eight countries.

There are twenty drug master file entries for nevirapine. Nine 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
The Aurum Institute NPCPhase 1/Phase 2
Johns Hopkins UniversityPhase 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
See Plans and PricingSee Plans and Pricing50MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing200MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing200MGTABLET; 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 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 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
Aurobindo NEVIRAPINE nevirapine TABLET;ORAL 077521-001 May 22, 2012 AB RX No No 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

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 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim VIRAMUNE nevirapine TABLET;ORAL 020636-001 Jun 21, 1996 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 See Plans and Pricing See Plans and Pricing
>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.
Authorised yes no no 2009-11-30
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for nevirapine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0429987 18/1999 Austria See Plans and Pricing PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
0429987 C990022 Netherlands See Plans and Pricing 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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