VIRAMUNE Drug Patent Profile

When do Viramune patents expire, and when can generic versions of Viramune launch?

Viramune is a drug marketed by Boehringer Ingelheim and is included in three NDAs. There is one patent protecting this drug.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Viramune

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

Summary for VIRAMUNE

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	42
Patent Applications:	5,011
Drug Prices:	Drug price information for VIRAMUNE
What excipients (inactive ingredients) are in VIRAMUNE?	VIRAMUNE excipients list
DailyMed Link:	VIRAMUNE at DailyMed

See drug prices for VIRAMUNE

Recent Clinical Trials for VIRAMUNE

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

Sponsor	Phase
National Institutes of Health (NIH)	Phase 4
Columbia University	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4

See all VIRAMUNE clinical trials

Pharmacology for VIRAMUNE

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

US Patents and Regulatory Information for VIRAMUNE

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	nevirapine	SUSPENSION;ORAL	020933-001	Sep 11, 1998		DISCN	Yes	No
Boehringer Ingelheim	VIRAMUNE XR	nevirapine	TABLET, EXTENDED RELEASE;ORAL	201152-001	Mar 25, 2011		DISCN	Yes	No
Boehringer Ingelheim	VIRAMUNE	nevirapine	TABLET;ORAL	020636-001	Jun 21, 1996		DISCN	Yes	No
Boehringer Ingelheim	VIRAMUNE XR	nevirapine	TABLET, EXTENDED RELEASE;ORAL	201152-002	Nov 8, 2012		DISCN	Yes	No

Expired US Patents for VIRAMUNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	VIRAMUNE	nevirapine	SUSPENSION;ORAL	020933-001	Sep 11, 1998
Boehringer Ingelheim	VIRAMUNE	nevirapine	TABLET;ORAL	020636-001	Jun 21, 1996

EU/EMA Drug Approvals for VIRAMUNE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Viramune	nevirapine	EMEA/H/C/000183 Tablets and oral suspensionViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents, and children of any age.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.50- and 100-mg prolonged-release tabletsViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adolescents and children three years and above and able to swallow tablets.Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.400-mg prolonged-release tabletsViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents and children three years and above and able to swallow tablets.Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.	Authorised	no	no	no	1998-02-04
Teva B.V.	Nevirapine Teva	nevirapine	EMEA/H/C/001119 Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV 1 infected adults, adolescents, and children of any age.Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing.	Withdrawn	yes	no	no	2009-11-30

International Patents for VIRAMUNE

See the table below for patents covering VIRAMUNE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2019812	NOUVEAU 5,11-DIHYDRO-6H-DIPYRIDO[3,2-B:2',3'-E][1,4]DIAZEPIN-6-ONES ET LEUR UTILISATION DANS LA PREVENTION ET LE TRAITEMENT DU SIDA (NOVEL 5,11-DIHYDRO-6H-DIPYRIDO[3,2-B:2',3'-E][1,4]DIAZEPIN-6-ONES AND THEIR USE IN THE PREVENTION OR TREATMENT OF AIDS)
Canada	2030056	5,11-DIHYDRO-6H-DIPYRIDO[3,2-B:2',3'-E][1,4]DIAZEPINES ET LEUR UTILISATION POUR LA PREVENTION OU LE TRAITEMENT DE L'INFECTION PAR LE HIV (5,11-DIHYDRO-6H-DIPYRIDO[3,2-B:2',3'-E][1,4]DIAZEPINES AND THEIR USE IN THE PREVENTION OR TREATMENT OF HIV INFECTION)
European Patent Office	0429987	5,11-Dihydro-6H-dipyrido[3,2-b:2'3'-e] [1,4]diazépines et leur utilisation pour prévenir ou traiter l'infection par le VIH (5,11-Dihydro-6H-dipyrido[3,2-b:2',3'-e] [1,4]diazepines and their use in the prevention or treatment of HIV infection)
Spain	2063202
Finland	92828
Hungary	904021

Supplementary Protection Certificates for VIRAMUNE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	18/1999	Austria		PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
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
0429987	990022	Netherlands		990022, 20101116, EXPIRES: 20121222
0429987	9990018-5 9991018-4	Sweden		PRODUCT NAME: 5,11-DIHYDRO-6H-DIPYRIDO3,2-B:2,3-E1,4DIAZEPINER OCH DERAS ANVAENDNING VID PREVENTION ELLER BEHANDLING AV HIV-INFEKTION; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRTION: LI 54393 19971223