NEVIRAPINE Drug Patent Profile

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

Nevirapine is a drug marketed by Aurobindo, Cipla, 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-three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nevirapine

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

Summary for NEVIRAPINE

US Patents:	0
Applicants:	16
NDAs:	23
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	220
Patent Applications:	4,617
Drug Prices:	Drug price information for NEVIRAPINE
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

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
Aurobindo	NEVIRAPINE	nevirapine	SUSPENSION;ORAL	077702-001	May 22, 2012	AA	RX	No	Yes
Hetero Labs Ltd Iii	NEVIRAPINE	nevirapine	TABLET;ORAL	078584-001	May 22, 2012	AB	RX	No	No
Strides Pharma	NEVIRAPINE	nevirapine	TABLET;ORAL	078195-001	May 22, 2012	AB	RX	No	No
Aurobindo Pharma	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	207698-001	Feb 28, 2017		DISCN	No	No
Alvogen	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	204621-001	Jul 10, 2015		DISCN	No	No
Sandoz	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	203411-001	Apr 3, 2014	AB	RX	No	No

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/000183Tablets 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/001119Nevirapine 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

Market Dynamics and Financial Trajectory for Nevirapine

Last updated: July 28, 2025

Introduction

Nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), has played a pivotal role in the management of HIV/AIDS since its approval in the late 1990s. As an antiretroviral drug, nevirapine's market trajectory is influenced by evolving guidelines, competitors, manufacturing landscapes, and emerging innovations in HIV treatment. This analysis delineates the current market dynamics and forecasts the financial trajectory of nevirapine, offering critical insights for stakeholders across the pharmaceutical supply chain.

Historical Context and Regulatory Landscape

Originally developed by Boehringer Ingelheim, nevirapine received FDA approval in 1996, establishing itself as one of the first oral antiretroviral agents. Its utility was particularly significant in resource-limited settings owing to affordability and ease of use. The drug's mechanism—binding directly to reverse transcriptase—complemented combination antiretroviral therapy (cART) regimens.

Regulatory shifts, including updates from the WHO and national agencies, have continually shaped its application. Notably, the WHO endorsed nevirapine for preventing mother-to-child transmission (PMTCT), fueling demand in global health initiatives. However, advances in HIV therapy have introduced more potent and tolerable agents, impacting nevirapine's market share.

Current Market Dynamics

Global Adoption and Usage Trends

Despite its historical prominence, nevirapine’s market share has declined in developed countries, primarily due to safety concerns—particularly hepatotoxicity and hypersensitivity reactions—and the availability of alternative agents such as efavirenz and integrase inhibitors. Conversely, in low- and middle-income countries (LMICs), nevirapine remains relevant, primarily driven by cost-effectiveness and simplified cold chain requirements, fortifying its position within global HIV programs.

Manufacturing and Supply Chain Aspects

Multiple generic manufacturers operate across Asia and Africa, contributing to widespread access. Patent expirations in key jurisdictions have facilitated generic proliferation, leading to reduced prices—an advantageous factor for public health contracts but exerting downward pressure on revenue for original patent holders. However, geopolitical factors and supply chain disruptions—exacerbated during the COVID-19 pandemic—have occasionally hindered consistent availability.

Competitive Landscape

Nevirapine faces stiff competition from newer agents boasting better tolerability, such as rilpivirine, dolutegravir, and bictegravir. The latter have garnered growing preference due to fewer adverse effects and simplified dosing schedules. Nonetheless, in resource-constrained environments, nevirapine persists due to its affordability and established efficacy.

Pricing and Reimbursement Dynamics

Pricing strategies are heavily influenced by generic competition. In LMICs, nevirapine is often supplied at prices well below $10 per tablet, making it an appealing option for national HIV programs. International donors, including PEPFAR and the Global Fund, heavily subsidize procurement, reinforcing its market presence.

Regulatory Challenges and Adverse Effects

Adverse effect profiles—particularly hepatotoxicity and skin reactions—have led to restrictions in certain populations (e.g., women with higher CD4 counts). Regulatory authorities have issued warnings and updated usage guidelines, compelling prescribers to weigh risks and benefits carefully.

Financial Trajectory Analysis

Revenue Trends and Forecasts

Historically, global sales of nevirapine peaked during the early 2000s, driven by widespread adoption in LMICs. As newer agents gained ground and guidelines shifted towards integrase inhibitor-based regimens, revenue growth plateaued and declined in high-income markets.

Forecasts indicate that the global market for nevirapine will continue to decline modestly, mainly due to the gradual phasing out in developed countries. However, in LMICs, it is projected to remain a staple component of HIV treatment programs for at least the next decade, supported by its cost advantages and ongoing procurement commitments.

Impact of Patent Expiries and Generics

Patent expirations in major jurisdictions—such as India and Africa—have spurred a surge in generic production, significantly reducing drug prices. This proliferation diminishes profit margins for patent-holding companies but ensures broader access and sustained revenues for generic manufacturers.

Emerging Opportunities and Challenges

Despite declining revenue in mature markets, opportunities exist within neglected markets and specialized pediatric formulations. Conversely, challenges include the potential for regulatory restrictions due to safety concerns, and the dominance of newer agents which threaten continued market share.

Research and Development Outlook

Given evolving treatment paradigms, investment in novel formulations or combination therapies incorporating nevirapine appears limited. Most R&D efforts are increasingly pivoting toward drugs with improved safety profiles and resistance management, reducing nevirapine’s future growth potential.

Key Market Drivers

• Global Health Initiatives: Sustained donations and subsidies in LMICs uphold nevirapine’s market presence.
• Generic Manufacturing: Price competition drives demand, ensuring continued access.
• Treatment Guidelines: Prescriptions in resource-limited settings primarily depend on affordability and logistical factors.
• Regulatory Environment: Warnings and restrictions influence prescribing patterns and market viability.

Key Market Barriers

• Safety Concerns: Hepatotoxicity and skin hypersensitivity limit use, especially where safer options exist.
• Market Competition: Availability and preference for integrase inhibitors and other NNRTIs diminish demand.
• Patent and Regulatory Challenges: Patent expiries and safety restrictions impact profitability.
• Emerging Resistance: Potential for resistance development necessitates careful prescribing, possibly affecting usage.

Concluding Remarks

Nevirapine's market trajectory embodies the classic lifecycle of a pioneering antiretroviral agent: robust uptake in initial years, gradual decline in developed markets, and sustained demand in resource-poor settings. Its financial future hinges on global health policies, manufacturing trends, and ongoing competition from superior agents. Strategic positioning within HIV management, especially in LMICs, will determine its long-term commercial viability.

Key Takeaways

• Market Decline in Developed Countries: Due to safety issues and competition from newer agents, sales are expected to decline further in high-income markets.
• Sustained Presence in LMICs: Cost-effectiveness and existing infrastructure will uphold its role in resource-limited HIV programs.
• Impact of Generics: Expiry of patents has democratized access, pressuring branded sales but expanding global reach.
• Regulatory and Safety Constraints: Ongoing safety concerns may limit expansion and influence prescribing practices.
• Innovation Barriers: Limited R&D activity suggests a declining role for nevirapine in future HIV therapy developments.

FAQs

1. Will nevirapine regain market share with new formulations?
Unlikely. The current trend favors agents with better safety and efficacy profiles, and no significant formulations of nevirapine are anticipated that could reverse its decline.

2. How do patent expiries affect nevirapine’s profitability?
Patent expiries enable generic manufacturers to produce lower-cost versions, reducing prices and profit margins for original developers but increasing global access.

3. Is nevirapine still viable for new HIV patients?
In high-income countries, probably not, due to safety concerns and superior alternatives; however, in resource-limited settings, it remains a practical option.

4. What impact have safety concerns had on regulatory status?
Regulatory agencies have implemented warnings and restrictions, which influence prescribing patterns and limit wider adoption.

5. What are the prospects for nevirapine in the next decade?
Its role is expected to diminish further in developed markets but remain relevant in LMICs, primarily driven by global health funding and procurement policies.

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Sources:
[1] WHO Treatment Guidelines and Policy Documents
[2] IMS Health Data Reports (2022)
[3] Boehringer Ingelheim Annual Reports
[4] Global Fund Procurement Data
[5] Recent Clinical Guidelines on HIV Treatment