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Last Updated: March 29, 2024

NEVIRAPINE Drug Patent Profile


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When do Nevirapine patents expire, and what generic alternatives are available?

Nevirapine is a drug marketed by Aurobindo, Cipla, 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-three NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Nevirapine

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

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Drug patent expirations by year for NEVIRAPINE
Drug Prices for NEVIRAPINE

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Recent Clinical Trials for NEVIRAPINE

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

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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
Aurobindo NEVIRAPINE nevirapine SUSPENSION;ORAL 077702-001 May 22, 2012 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd Iii NEVIRAPINE nevirapine TABLET;ORAL 078584-001 May 22, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma NEVIRAPINE nevirapine TABLET;ORAL 078195-001 May 22, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 207698-001 Feb 28, 2017 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

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

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