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Last Updated: December 12, 2019

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Nevirapine - Generic Drug Details

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What are the generic 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 Inc, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan, Sandoz Inc, Tech Organized, 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. Fifteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for nevirapine

See drug prices for nevirapine

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
Synonyms for nevirapine
11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[2,3-e:3',2'-b][1,4]diazepin-6-one
11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[2,3-e:3',2'-b][1,4]diazepin-6-one & PRO 140 (Anti-CCR5 monoclonal antibody)
11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2 inverted exclamation mark ,3 inverted exclamation mark -e][1,4]diazepin-6-one
11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one
11-cyclopropyl-4-methyl-5H-dipyrido[[?],[?]][1,4]diazepin-6-one
11-cyclopropyl-4-methyl-5H-dipyrido[2,3-b:3',2'-e][1,4]diazepin-6-one
11-Cyclopropyl-4-methyl-5H-dipyrido[3,2-b
11-CYCLOPROPYL-4-METHYL-5H-DIPYRIDO[3,2-B:2',3'-E][1,4]DIAZEPIN-6(11H)-ONE
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido-[3,2-b:2',3'-e][1,4]diazepin-6-one
11-Cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido(3,2-b:2',3'-e)(1,4)diazepin-6-one
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b :2',3'-e][1,4 ]diazepin-6-one
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2 ,3 -e][1,4]diazepin-6-one
11-Cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2', 3'-e][1,4]diazepin-6-one
11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO[3,2-B:2',3'-E][1,4]DIAZEPIN-6-ONE
129618-40-2
1vrt
2-cyclopropyl-7-methyl-2,4,9,15-tetraazatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3,5,7,12,14-hexaen-10-one
2-cyclopropyl-7-methyl-2,4,9,15-tetraazatricyclo[9.4.0.0;{3,8}]pentadeca-1(15),3,5,7,11,13-hexaen-10-one
2-cyclopropyl-7-methyl-2,4,9,15-tetraazatricyclo[9.4.0.0(3),]pentadeca-1(15),3(8),4,6,11,13-hexaen-10-one
2hny
5H-Dipyrido(3,2-b:2',3'-e)(1,4)diazepin-6-one, 5,11-dihydro-11-cyclopropyl-4-methyl-
618N402
6H-Dipyrido(3,2-b:2',3'-e)(1,4)diazepin-6-one, 11-cyclopropyl-5,11-dihydro-4-methyl-
6H-dipyrido[2,3-e:3',2'-b][1,4]diazepin-6-one, 11-cyclopropyl-5,11-dihydro-4-methyl-
99DK7FVK1H
AB0013383
AB00393001_16
AB00393001_17
AB00393001-13
AB00393001-15
AB07544
AB2000266
AC-643
AC1L1I81
AJ-08226
AK143126
AKOS005504351
ALBB-027264
AN-15635
BBL010768
BC206673
BCP05587
BDBM1434
BI-RG 587
BI-RG-587
BI-RG-587 & CD4-IgG
BIDD:GT0326
BIRG 0587
BIRG 587
BIRG-0587
BIRG-587
BIRG587
C07263
C15H14N4O
CAS-129618-40-2
CCG-100939
CHEBI:63613
CHEMBL57
CPD000048458
CS-2252
CTK8E7455
D00435
DB00238
DSSTox_CID_10787
DSSTox_GSID_31797
DSSTox_RID_78889
DTXSID7031797
F2173-0607
FT-0607215
H954
HMS2051J09
HMS2231O23
HMS3264D21
HMS3371E03
HMS3393J09
HMS3655I08
HMS3715B10
HSDB 7164
HY-10570
I02-0310
KB-64802
KS-00000KZF
KS-5019
LS-2289
MCULE-8608154492
MFCD00866928
MFCD00866928 (98%)
MLS000084585
MLS000759409
MLS001055309
MLS001201730
MLS001424058
MLS006011423
MolPort-002-507-817
N0922
N11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e]-[1,4]diazepin-6-one & CD4-immunoadhesin
NC00189
NCGC00065890-02
NCGC00065890-03
NCGC00065890-04
NCGC00065890-05
NCGC00065890-07
NCGC00258324-01
NEV
Nevirapine (anhydrous), European Pharmacopoeia (EP) Reference Standard
Nevirapine (JAN/USP/INN)
Nevirapine (Viramune)
Nevirapine [USAN:INN]
Nevirapine [USAN:USP:INN:BAN]
Nevirapine & CD4-IgG
Nevirapine & PRO 140
Nevirapine anhydrous
Nevirapine anhydrous, United States Pharmacopeia (USP) Reference Standard
Nevirapine for peak identification, European Pharmacopoeia (EP) Reference Standard
Nevirapine solution, 1.0 mg/mL in methanol, certified reference material
Nevirapine, 98%
Nevirapine, Pharmaceutical Secondary Standard; Certified Reference Material
Nevirapine,(S)
NON-NUCLEOSIDE RT INHIBITOR NEVIRAPINE
NQDJXKOVJZTUJA-UHFFFAOYSA-N
NSC 641530
NSC-641530
NSC-759902
NSC641530
NSC759902
NVP
Opera_ID_934
Pharmakon1600-01503842
R3924
RL01415
RT-014690
S1742
SAM001246551
SC-17266
SCHEMBL3318
SMR000048458
ST24038235
STK580320
SW197569-2
SY009679
Tox21 110982
Tox21_110982
Tox21_110982_1
Tox21_200770
UNII-99DK7FVK1H
Viramune
Viramune (TN)
Viramune IR
Viramune XR
Viramune;BI-RG 587
Viramune(TM)
Z1695906730
ZB000592
ZINC4778
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
Apotex Inc NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 205258-001 Apr 3, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Micro Labs Ltd NEVIRAPINE nevirapine TABLET;ORAL 203080-001 May 22, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla NEVIRAPINE nevirapine SUSPENSION;ORAL 207684-001 Aug 3, 2017 AA 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 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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
McKesson
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Moodys
Mallinckrodt

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