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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-two patent family members in twenty-seven countries.

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

Summary for VIRAMUNE XR

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	95
Clinical Trials:	34
Patent Applications:	4,703
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIRAMUNE XR
Prior Art and Litigation Support	Order Prior Art and Litigation support for VIRAMUNE XR
DailyMed Link:	VIRAMUNE XR at DailyMed

Pharmacology for VIRAMUNE XR

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 2B6 Inducers

Medical Subject Heading (MeSH) Categories for VIRAMUNE XR

Anti-HIV Agents

Cytochrome P-450 CYP3A Inducers

Reverse Transcriptase Inhibitors

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

US Patents and Regulatory Information for VIRAMUNE XR

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
Boehringer Ingelheim	VIRAMUNE XR	nevirapine	TABLET, EXTENDED RELEASE;ORAL	201152-001	Mar 25, 2011	AB	RX	Yes	Yes

Expired US Patents for VIRAMUNE XR

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

Paragraph IV (Patent) Challenges for VIRAMUNE XR

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	400 mg

International Patents for VIRAMUNE XR

Country	Patent Number	Estimated Expiration
Ecuador	SP099561
Canada	2687491
Poland	2155169
South Africa	200904939
Peru	10352013
Spain	2574836
South Korea	20100020447

Supplementary Protection Certificates for VIRAMUNE XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0429987	18/1999	Austria		PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
0429987	99C0019	France		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		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		PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223
0429987	C990022	Netherlands		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