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Last Updated: August 3, 2021

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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. Eleven 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
GlaxoSmithKlinePhase 3
Fundação Bahiana de InfectologiaPhase 3
Simbec OrionPhase 2

See all NEVIRAPINE clinical trials

Generic filers with tentative approvals for NEVIRAPINE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free50MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free200MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free200MGTABLET; 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
Prinston Inc NEVIRAPINE nevirapine TABLET;ORAL 078644-001 May 22, 2012 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Macleods Pharms Ltd NEVIRAPINE nevirapine TABLET;ORAL 090688-001 Jan 14, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apotex Inc NEVIRAPINE nevirapine TABLET;ORAL 203021-001 May 22, 2012 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Cipla NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 206448-001 Oct 15, 2015 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 it Free ⤷  Try it Free
Boehringer Ingelheim VIRAMUNE nevirapine TABLET;ORAL 020636-001 Jun 21, 1996 ⤷  Try it Free ⤷  Try it Free
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 ⤷  Try it Free ⤷  Try it Free
>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 C990022 Netherlands ⤷  Try it Free 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 ⤷  Try it Free PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223
0429987 18/1999 Austria ⤷  Try it Free PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
0429987 99C0021 Belgium ⤷  Try it Free PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223
0429987 SPC/GB99/020 United Kingdom ⤷  Try it Free 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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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
AstraZeneca
Medtronic
McKesson
Express Scripts

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