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Last Updated: August 8, 2020

DrugPatentWatch Database Preview

NEVIRAPINE - Generic Drug Details

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What are the generic drug sources for nevirapine and what is the scope of freedom to operate?

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. Twelve suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for NEVIRAPINE

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Recent Clinical Trials for NEVIRAPINE

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

SponsorPhase
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 4
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 2
Institut National de la Santé Et de la Recherche Médicale, FrancePhase 2

See all NEVIRAPINE clinical trials

Generic filers with tentative approvals for NEVIRAPINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial50MGTABLET; ORAL
  Start Trial  Start Trial200MGTABLET; ORAL
  Start Trial  Start 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 NDA Submissiondate
NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL nevirapine 203411 2016-12-21
VIRAMUNE XR TABLET, EXTENDED RELEASE;ORAL nevirapine 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
Mylan NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 205651-001 Oct 27, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Tech Organized NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 207467-002 Jul 31, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 206879-001 Oct 6, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 205258-001 Apr 3, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo NEVIRAPINE nevirapine SUSPENSION;ORAL 077702-001 May 22, 2012 AA RX No No   Start Trial   Start Trial   Start Trial
Tech Organized NEVIRAPINE nevirapine TABLET;ORAL 203176-001 May 22, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd NEVIRAPINE nevirapine TABLET;ORAL 090688-001 Jan 14, 2019 AB RX No No   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

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   Start Trial   Start Trial
Boehringer Ingelheim VIRAMUNE nevirapine TABLET;ORAL 020636-001 Jun 21, 1996   Start Trial   Start Trial
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NEVIRAPINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 99C0021 Belgium   Start Trial PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223
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
0429987 18/1999 Austria   Start Trial PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
AstraZeneca
Medtronic
McKesson
Express Scripts

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