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, Pharmobedient, 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. Six 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:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	222
Patent Applications:	7,602
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
Organization providing support methodology coordination (Institut Pierre Louis d'Epidmiologie et de Sant Publique)	PHASE2
ANRS, Emerging Infectious Diseases	PHASE2
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	PHASE2

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
Cipla	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	206448-001	Oct 15, 2015		DISCN	No	No
Prinston Inc	NEVIRAPINE	nevirapine	TABLET;ORAL	078644-001	May 22, 2012		DISCN	No	No
Cipla	NEVIRAPINE	nevirapine	TABLET;ORAL	077956-001	May 22, 2012	AB	RX	No	No
Apotex	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	205258-001	Apr 3, 2014		DISCN	No	No
Aurobindo Pharma	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	207698-001	Feb 28, 2017		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 XR	nevirapine	TABLET, EXTENDED RELEASE;ORAL	201152-001	Mar 25, 2011
Boehringer Ingelheim	VIRAMUNE	nevirapine	TABLET;ORAL	020636-001	Jun 21, 1996

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

International Patents for NEVIRAPINE

Country	Patent Number	Title	Estimated Expiration
New Zealand	578664
World Intellectual Property Organization (WIPO)	2008154234
Japan	2010520891
South Africa	200904939
China	101784263

Supplementary Protection Certificates for NEVIRAPINE

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	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	99C0021	Belgium		PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 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

Market Dynamics and Financial Trajectory for Nevirapine

Last updated: February 20, 2026

Nevirapine, an antiretroviral drug used primarily for HIV treatment, faces a complex market environment driven by evolving treatment guidelines, patent statuses, and competition from newer therapies. Its financial trajectory varies across regions, influenced by patent expiry, regulatory shifts, and manufacturer strategies.

Market Overview

Nevirapine has been a cornerstone in HIV therapy since its approval in 1996. It belongs to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class. The drug maintains a market in low- and middle-income countries where access to generic versions and established treatment protocols drive demand. Conversely, high-income markets increasingly favor integrase inhibitors and combination therapies with improved efficacy and safety profiles.

Key Market Drivers

• Global HIV Burden: An estimated 38 million people living with HIV globally, with sub-Saharan Africa accounting for 67% of cases (UNAIDS, 2022).
• Treatment Guidelines: WHO recommends first-line ART regimes including NNRTIs like nevirapine, especially in resource-limited settings.
• Generic Competition: Multiple generics available in low-income markets, reducing prices and expanding access.
• Patents and Market Exclusivity: patents expired or are nearing expiry in several jurisdictions, enabling generic manufacturing.

Patent and Regulatory Status

Nevirapine's original patent protections have largely expired:

Region	Patent Expiry	Remaining Exclusivity
United States	2013	No
European Union	2012	No
India	2004 (patent granted before 2005 exclusion)	No

Regulatory approvals persist in some regions, but market entry barriers are diminished due to generic availability.

Revenue and Sales Trends

Historical and projected revenue streams:

Year	Estimated Global Sales (USD millions)	Notes
2015	350	Peak sales pre-patent expiry
2018	80	Decline due to competition from newer drugs
2022	45	Further decline, shift to integrase inhibitors
2025 (projected)	30	Continued decrease, depends on regional demand

The sharp decline post-2013 correlates with patent expiration, increased generic competition, and the introduction of alternative treatments.

Regional Market Insights

• Africa: Most significant market; price sensitivity favors generics. Estimated dominance: 80% of local HIV treatment formulations contain nevirapine.
• Asia: India and Southeast Asia use generic nevirapine extensively; revenue remains stable but declining.
• Europe & North America: Limited use; primarily in salvage therapy or regions with limited access to newer treatments.

Future Outlook

The landscape expects further erosion in nevirapine’s market share:

• Regulatory Impact: Patent filings and expiration influence availability.
• Treatment Evolution: Shift toward integrase inhibitors (e.g., dolutegravir) reduces reliance on NNRTIs.
• Pricing Pressure: Generics dominate markets, compressing revenues.
• Innovation and New Formulations: Limited pipeline indicates restricted growth potential.

Financial Trajectory Summary

Scenario	Revenue Trend	Key Factors
conservative decline	Revenue approaches USD 20-30 million globally by 2030	Patent expiries, generics, substitution by newer therapies
aggressive decline	Revenue falls below USD 10 million by 2025	Market saturation, preference for first-line alternatives

Strategic Considerations

Manufacturers should focus on:

• Diversification into combination therapies
• Developing formulations for pediatric and fixed-dose regimens
• Leveraging global health partnerships
• Navigating patent landscapes for potential extensions or licenses

Key Takeaways

• The nevirapine market is in decline due to patent expirations, generics, and newer treatments.
• Demand persists mainly in resource-limited settings, where affordability influences therapy choices.
• Revenue projections indicate a downward trend with limited growth opportunities.
• Regulatory and patent statuses are critical in shaping future market dynamics.
• Companies must innovate or pivot to alternative product lines to sustain growth.

FAQs

1. How does patent expiry impact nevirapine sales?
Patent expiry introduces generic competition, significantly lowering prices and reducing brand-name sales volume.

2. What alternative drugs are replacing nevirapine in HIV treatment?
Integrase inhibitors like dolutegravir and bictegravir are preferred due to better safety and efficacy profiles.

3. Is there still demand for nevirapine in high-income countries?
Demand is minimal in high-income countries, limited to salvage or specific cases.

4. Are there ongoing patent protections in any regions?
Most patents have expired or are being challenged; some regional patents may still offer exclusivity, but their impact is limited.

5. Can manufacturers extend nevirapine’s market life?
Through formulation improvements, fixed-dose combinations, or positioning in niche markets, though gains are limited given the clinical landscape.

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References

[1] UNAIDS. (2022). Global HIV & AIDS statistics — 2022 fact sheet. https://unaids.org/en/resources/fact-sheet

[2] World Health Organization. (2021). Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring. https://www.who.int/publications/i/item/9789240031593