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:	6,999
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
Tech Organized	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	207467-002	Jul 31, 2017		DISCN	No	No
Tech Organized	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	207467-001	Jul 31, 2017		DISCN	No	No
Alvogen	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	204621-002	Nov 9, 2015		DISCN	No	No
Hetero Labs Ltd Iii	NEVIRAPINE	nevirapine	TABLET;ORAL	078584-001	May 22, 2012	AB	RX	No	No
Sandoz	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	203411-001	Apr 3, 2014	AB	RX	No	No
Prinston Inc	NEVIRAPINE	nevirapine	TABLET;ORAL	078644-001	May 22, 2012		DISCN	No	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
European Patent Office	2155169	FORMULATION À LIBÉRATION PROLONGÉE DE NÉVIRAPINE (EXTENDED RELEASE FORMULATION OF NEVIRAPINE)
Ecuador	SP099561	FORMULACIÓN DE NEVIRAPINA DE LIBERACIÓN PROLONGADA
Brazil	PI0811732	FORMULAÇÃO DE LIBERAÇÃO PROLONGADA DE NEVIRAPINA
Japan	5417662
Eurasian Patent Organization	200900958	ПРЕПАРАТ НЕВИРАПИНА ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ
New Zealand	578664	EXTENDED RELEASE FORMULATION OF NEVIRAPINE
Hong Kong	1145806	EXTENDED RELEASE FORMULATION OF NEVIRAPINE

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	18/1999	Austria		PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
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	99C0019	France		PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 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

NEVIRAPINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nevirapine

Introduction

Nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), has been a crucial component in the treatment of HIV-1 since its introduction in the early 1990s. This article delves into the market dynamics and financial trajectory of nevirapine, exploring its effectiveness, market demand, pricing, and the impact of generic versions.

Historical Context and Approval

Nevirapine was first approved by the FDA in June 1996 and in the European Union in February 1998. It is manufactured by Boehringer Ingelheim under the trade name Viramune[1][4].

Mechanism of Action and Effectiveness

Nevirapine works by inhibiting the reverse transcriptase enzyme of HIV, preventing the virus from replicating. When used in combination with other antiretroviral drugs, nevirapine significantly reduces HIV-1 viral load and increases CD4 cell counts. However, it is not effective against HIV-2[1][4].

Clinical Trials and Efficacy

Clinical trials have shown that nevirapine, when combined with zidovudine and didanosine, leads to greater decreases in viral load and increases in CD4 cell counts compared to regimens without nevirapine. These trials also demonstrated fewer cases of HIV disease progression[1].

Market Demand and Utilization Patterns

The demand for nevirapine, like other antiretroviral drugs, has been influenced by global health guidelines and economic factors. Despite the global economic crisis, the demand for antiretroviral drugs, including nevirapine, has increased, particularly in low- and middle-income countries. This is due to the scale-up of antiretroviral therapy and the need for less toxic regimens[2].

Forecasting Demand

Studies have projected an increasing demand for antiretroviral drugs, with nevirapine being one of the options, especially in resource-limited settings. The demand is driven by the need to treat new patients and those switching to less toxic regimens. By 2012, it was projected that between 7.1 million and 8.4 million people would be receiving antiretroviral therapy, with a significant portion potentially using nevirapine[2].

Pricing and Generic Versions

The pricing of nevirapine has been significantly impacted by the availability of generic versions. Generic drug prices generally fall with the number of competitors, approaching long-run marginal costs when there are eight or more competitors. This has made nevirapine more affordable, especially in lower- and middle-income countries[3].

Impact of Generic Competition

Generic versions of nevirapine have been available since the patent expiration, leading to increased competition and lower prices. The entry of multiple generic firms reduces expected rents, making the drug more accessible. However, the initial generic monopolist often charges prices 35-50% above long-run marginal costs, which decline as more competitors enter the market[3].

Financial Trajectory

The financial trajectory of nevirapine is characterized by a decline in revenue for the original manufacturer, Boehringer Ingelheim, as generic versions gain market share. Despite this, nevirapine remains a significant player in the antiretroviral market due to its low cost and effectiveness.

Revenue and Profit Margins

The revenue from nevirapine has decreased over the years as generic competition increases. However, the drug continues to generate substantial revenue, particularly in regions where it is used as an alternative to more expensive antiretrovirals like efavirenz. The profit margins for generic manufacturers are influenced by the number of competitors and the expected market size[3].

Regulatory and Guidelines Impact

Nevirapine is no longer recommended as a preferred first-line antiretroviral treatment in many guidelines due to the availability of more effective and safer alternatives like efavirenz. However, its low cost makes it a viable option in some lower- and middle-income countries[1].

Guidelines and Recommendations

British, European, U.S., and World Health Organization guidelines no longer list nevirapine as a preferred first-line treatment. However, it is still used in certain contexts, such as in combination with other antiretrovirals for children and as part of post-exposure prophylaxis for infants born to HIV-positive mothers[1].

Use in Special Populations

Nevirapine is used in various special populations, including children and pregnant women.

Children

Nevirapine is safe and effective in children from birth and is recommended as an alternative third agent in combination with two NRTIs for children up to six years of age in Europe[1].

Pregnant Women and Mother-to-Child Transmission

A single dose of nevirapine administered to both mother and infant can significantly reduce mother-to-child transmission of HIV. However, studies have shown mixed results regarding the addition of other antiretrovirals to this regimen[5].

Future Outlook

The future outlook for nevirapine is shaped by ongoing research, changing treatment guidelines, and market dynamics.

Emerging Uses

Recent studies suggest that nevirapine may have potential uses beyond HIV treatment, such as in the treatment of thyroid cancer. This could expand its market and financial trajectory[4].

Market Competition

The antiretroviral market is highly competitive, with new drugs and combinations being developed. Nevirapine's position will continue to be influenced by its cost-effectiveness and the availability of generic versions[2].

Key Takeaways

• Effectiveness: Nevirapine is effective in reducing HIV-1 viral load and increasing CD4 cell counts when used in combination with other antiretrovirals.
• Market Demand: Demand is driven by the need for antiretroviral therapy in low- and middle-income countries.
• Pricing and Generics: Generic competition has significantly reduced the price of nevirapine, making it more accessible.
• Financial Trajectory: Revenue has declined for the original manufacturer but remains substantial due to its low cost and effectiveness.
• Regulatory Impact: No longer a preferred first-line treatment but still used in certain contexts.
• Special Populations: Used in children and pregnant women to prevent mother-to-child transmission.

FAQs

What is nevirapine used for?

Nevirapine is used to treat HIV-1 infection by reducing the viral load and increasing CD4 cell counts when combined with other antiretroviral drugs.

Is nevirapine still recommended as a first-line treatment?

No, nevirapine is no longer recommended as a preferred first-line antiretroviral treatment in many guidelines due to the availability of more effective and safer alternatives.

How has generic competition affected nevirapine?

Generic competition has significantly reduced the price of nevirapine, making it more accessible, especially in lower- and middle-income countries.

Can nevirapine be used in children?

Yes, nevirapine is safe and effective in children from birth and is recommended as an alternative third agent in combination with two NRTIs for children up to six years of age.

What are the potential side effects of nevirapine?

Nevirapine can have serious side effects, including liver damage and skin reactions. It is advised not to start treatment with nevirapine if CD4 cell counts are above certain thresholds to minimize these risks[1].

References

1. Aidsmap: Nevirapine - Aidsmap
2. Wiley Online Library: Utilization Patterns and Projected Demand of Antiretroviral Drugs in Low- and Middle-Income Countries
3. Federal Trade Commission: Generic Drug Industry Dynamics
4. NCBI Bookshelf: Nevirapine - StatPearls
5. Oxford Academic: Randomized, Double-Blind, Placebo-Controlled Trial of Combined Antiretroviral Therapy for Prevention of Mother-to-Child Transmission of HIV-1 in Zimbabwe