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Last Updated: February 27, 2020

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VIRAMUNE XR Drug Profile


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

Viramune Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-three patent family members in twenty-eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Viramune Xr

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

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Summary for VIRAMUNE XR
International Patents:33
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 105
Clinical Trials: 34
Patent Applications: 4,324
Formulation / Manufacturing:see details
Drug Prices: Drug price information for VIRAMUNE XR
DailyMed Link:VIRAMUNE XR at DailyMed
Drug patent expirations by year for VIRAMUNE XR
Drug Prices for VIRAMUNE XR

See drug prices for VIRAMUNE XR

Recent Clinical Trials for VIRAMUNE XR

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

SponsorPhase
Ratiopharm GmbHPhase 1
University of AarhusPhase 4
Bandim Health ProjectPhase 4

See all VIRAMUNE XR clinical trials

Pharmacology for VIRAMUNE XR
Drug ClassHuman Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of ActionNon-Nucleoside Reverse Transcriptase Inhibitors
Cytochrome P450 3A Inducers
Cytochrome P450 2B6 Inducers
Synonyms for VIRAMUNE XR
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
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;BI-RG 587
Viramune(TM)
Z1695906730
ZB000592
ZINC4778
Paragraph IV (Patent) Challenges for VIRAMUNE XR
Tradename Dosage Ingredient NDA Submissiondate
VIRAMUNE XR TABLET, EXTENDED RELEASE;ORAL nevirapine 201152 2013-06-21

US Patents and Regulatory Information for VIRAMUNE XR

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-002 Nov 8, 2012 AB RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 AB RX Yes Yes   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

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Supplementary Protection Certificates for VIRAMUNE XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0429987 18/1999 Austria   Start Trial PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
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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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Mallinckrodt
Baxter
Harvard Business School
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.

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