NEVIRAPINE - Generic Drug Details

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, Macleods Pharms Ltd, Mylan, Norvium Bioscience, Sandoz, Tech Organized, Apotex Inc, Hetero Labs Ltd Iii, Micro Labs Ltd, 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-two patent family members in twenty-seven countries.

There are twenty drug master file entries for nevirapine. Eight suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for NEVIRAPINE

International Patents:	32
US Patents:	1
Tradenames:	3
Applicants:	17
NDAs:	26
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	220
Patent Applications:	7,022
Drug Prices:	Drug price trends for NEVIRAPINE
What excipients (inactive ingredients) are in NEVIRAPINE?	NEVIRAPINE excipients list
DailyMed Link:	NEVIRAPINE at DailyMed

See drug prices for NEVIRAPINE

Recent Clinical Trials for NEVIRAPINE

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

Sponsor	Phase
The Aurum Institute NPC	Phase 1/Phase 2
Johns Hopkins University	Phase 1/Phase 2
Jean-Pierre Routy	N/A

See all NEVIRAPINE clinical trials

Generic filers with tentative approvals for NEVIRAPINE

Applicant	Application No.	Strength	Dosage Form
		50MG	TABLET; ORAL
		200MG	TABLET; ORAL
		200MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for NEVIRAPINE

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

Medical Subject Heading (MeSH) Categories for NEVIRAPINE

Anti-HIV Agents

Cytochrome P-450 CYP3A Inducers

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NEVIRAPINE

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for NEVIRAPINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEVIRAPINE	Injection	nevirapine	5 mg/vial	203411	1	2016-12-21
VIRAMUNE XR	Extended-release Tablets	nevirapine	400 mg	201152	3	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
Mylan	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	205651-001	Oct 27, 2014	AB	RX	No	No
Boehringer Ingelheim	VIRAMUNE	nevirapine	TABLET;ORAL	020636-001	Jun 21, 1996		DISCN	Yes	No
Tech Organized	NEVIRAPINE	nevirapine	TABLET;ORAL	203176-001	May 22, 2012		DISCN	No	No
Strides Pharma	NEVIRAPINE	nevirapine	TABLET;ORAL	078195-001	May 22, 2012	AB	RX	No	No
Boehringer Ingelheim	VIRAMUNE XR	nevirapine	TABLET, EXTENDED RELEASE;ORAL	201152-001	Mar 25, 2011		DISCN	Yes	No
Apotex Inc	NEVIRAPINE	nevirapine	TABLET;ORAL	203021-001	May 22, 2012		DISCN	No	No

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
Boehringer Ingelheim	VIRAMUNE	nevirapine	TABLET;ORAL	020636-001	Jun 21, 1996
Boehringer Ingelheim	VIRAMUNE XR	nevirapine	TABLET, EXTENDED RELEASE;ORAL	201152-001	Mar 25, 2011

EU/EMA Drug Approvals for NEVIRAPINE

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 NEVIRAPINE

Country	Patent Number	Title	Estimated Expiration
Denmark	2155169
South Africa	200904939	Extended release formulation of nevirapine
Poland	2155169
Peru	20131035	FORMULACION DE NEVIRAPINA DE LIBERACION PROLONGADA
Peru	20090371	FORMULACION DE NEVIRAPINA DE LIBERACION PROLONGADA
Spain	2574836

Supplementary Protection Certificates for NEVIRAPINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	18/1999	Austria		PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205