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. Six 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
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	42
Patent Applications:	5,703
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
Columbia University	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4
University of Witwatersrand, South Africa	Phase 4

See all VIRAMUNE clinical trials

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	8,460,704
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	5,366,972*PED
Boehringer Ingelheim	VIRAMUNE	nevirapine	TABLET;ORAL	020636-001	Jun 21, 1996	5,366,972*PED

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/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 VIRAMUNE

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

Country	Patent Number	Title	Estimated Expiration
Germany	69002079
Greece	3030100
Russian Federation	2040527	DERIVATIVES OF DIPYRIDO-DIAZEPINE AND THEIR HYDRATES SHOWING BIOLOGICAL ACTIVITY
Germany	19975051

Supplementary Protection Certificates for VIRAMUNE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0429987	99C0019	France		PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 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
0429987	18/1999	Austria		PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205

Market Dynamics and Financial Trajectory for VIRAMUNE (Nevirapine)

Last updated: July 29, 2025

Introduction

VIRAMUNE (Nevirapine) stands as a cornerstone in the antiretroviral therapy (ART) landscape, primarily used to manage HIV-1 infection. Since its initial approval, its market presence has been shaped by evolving HIV demographics, regulatory shifts, and emerging treatment paradigms. This comprehensive analysis examines the current market dynamics and projected financial trajectory of VIRAMUNE, emphasizing key factors influencing its competitiveness and growth potential in the global HIV treatment arena.

Historical Context and Pharmaceutical Profile

Developed by Boehringer Ingelheim, VIRAMUNE (nevirapine) was approved by the US FDA in 1996 as part of combination antiretroviral regimens. Its mechanism as a non-nucleoside reverse transcriptase inhibitor (NNRTI) revolutionized HIV management, offering an oral, once-daily option that improved adherence.

Despite the advent of newer agents, VIRAMUNE retained a significant share in low- and middle-income countries (LMICs) due to its affordability and longstanding availability. However, the drug’s market share has diminished in high-income regions owing to concerns over resistance development, adverse effects, and pharmacokinetic inconveniences associated with older NNRTIs.

Market Dynamics

1. Evolving Treatment Guidelines and Regimens

Global HIV treatment guidelines increasingly favor integrase strand transfer inhibitors (INSTIs), such as dolutegravir (DTG), over older NNRTIs, including VIRAMUNE. The WHO recent guidelines recommend INSTI-based regimens as the preferred first-line therapies, citing superior efficacy, safety, and resistance profiles. This shift constrains VIRAMUNE's growth in high-income regions and limits its adoption in new treatment protocols.

2. Geographic Market Segmentation

• Low- and Middle-Income Countries (LMICs):
  In regions like Sub-Saharan Africa, VIRAMUNE remains relevant due to cost-effectiveness and widespread generic availability. It is often included as part of the recommended first-line combination therapies, such as those co-formulated with tenofovir and lamivudine. The sustained demand in these markets cushions overall sales, especially considering the still high HIV/AIDS burden there.

• High-Income Countries:
  These markets show declining use of VIRAMUNE, owing to the preference for INSTIs and concerns over adverse effects such as hepatotoxicity and skin rashes. Regulatory bodies like the FDA and EMA have placed restrictions on its use, further limiting market penetration.

3. Competitive Landscape

The market has seen significant competition from newer NNRTIs (e.g., rilpivirine) and INSTIs. Generic manufacturing has commoditized VIRAMUNE’s pricing, undermining profitability for patent-holding firms. Nevertheless, generic suppliers in LMICs sustain the drug’s market presence.

4. Patent Expiry and Generic Penetration

Patents for VIRAMUNE have expired or are approaching expiration in many jurisdictions, leading to a surge in generic production. The entry of generics has reduced prices substantially, increasing access but squeezing profit margins for original developers.

5. Regulatory and Safety Challenges

VIRAMUNE's safety profile—particularly risks of hepatotoxicity and hypersensitivity reactions—has prompted regulatory caution, especially in certain population subsets (e.g., women with high baseline CD4 counts). Regulatory agencies have issued warnings and contraindications, shaping prescribing practices.

Financial Trajectory

1. Revenue Trends

Global sales of VIRAMUNE peaked in the early 2000s, driven by widespread acceptance and inclusion in first-line regimens. However, sales have declined steadily owing to:

• The predominance of INSTI-based regimens.
• Efficacy and safety concerns.
• Market saturation in LMICs with robust generic competition.

For example, Boehringer Ingelheim reported modest revenues from VIRAMUNE, with revenues declining annually over the last decade [1].

2. Revenue Projections

Based on current market trends, the revenue outlook for VIRAMUNE is as follows:

• Short-term (1–3 years):
  Continued decline in high-income markets; stable or slight growth in LMICs driven by generic markets and ongoing HIV treatment programs.

• Long-term (4–10 years):
  Possible plateau or further decline unless new formulation innovations or combination products are introduced. The pharmaceutical landscape is unlikely to favor VIRAMUNE’s standalone products absent significant repositioning.

3. Investment and R&D Outlook

Boehringer Ingelheim and other players have not announced substantial R&D investments specifically targeting VIRAMUNE, reflecting its marginalized position in new HIV therapy development.

Emerging strategies focus on combination therapies with improved safety and simplified dosing, but VIRAMUNE’s integration remains limited due to its existing safety profile limitations. Unless a reformulation or new delivery method (e.g., long-acting injectables) emerges, its financial trajectory appears to be in decline.

4. Market Opportunities and Challenges

• Opportunities:

  • Continued demand in LMICs with low-cost generics.
  • Potential renewal through fixed-dose combination formulations eliminating adverse effects.

• Challenges:

  • Dominance of newer, more tolerable drugs.
  • Regulatory restrictions and safety concerns.
  • Alternative therapies overshadowing VIRAMUNE in developed markets.

Key Factors Influencing Future Dynamics

• Global HIV/AIDS Burden: Persistently high HIV prevalence in Sub-Saharan Africa and parts of Asia sustains demand for affordable ART options, supporting VIRAMUNE’s continued market presence in LMICs.

• Regulatory Environment: Stricter safety guidelines limit use in certain populations, impacting sales volume.

• Innovation Drive: Lack of ongoing R&D diminishes prospects for revitalizing VIRAMUNE’s market relevance.

• Patent and Competition Dynamics: Generics dominate, pressuring pricing and margins.

Conclusion

VIRAMUNE’s market is characterized by a complex interplay of established demand in resource-limited settings, shrinking relevance in advanced healthcare systems, and stiff competition from newer agents. Financial prospects hinge heavily on the trajectory of HIV epidemic control and global treatment strategies favoring newer, safer drugs.

While the drug continues to generate revenue primarily through generics in LMICs, its prospects in high-income markets are negligible, and overall sales are expected to decline progressively. Stakeholders must weigh the low-cost access benefits against safety concerns and market shifts, considering potential repositioning strategies to sustain relevance.

---

Key Takeaways

• Market shift towards INSTIs has marginalized VIRAMUNE in high-income regions, limiting growth prospects.

• In LMICs, VIRAMUNE remains vital due to affordability and broad access, bolstered by generic drug proliferation.

• Patent expiries and generic competition have significantly reduced profitability for original developers.

• Safety concerns and regulatory restrictions present ongoing challenges, constraining wider adoption.

• Future growth depends on the emergence of innovative formulations or combination therapies that address safety and adherence issues.

---

FAQs

1. Is VIRAMUNE still recommended as a first-line treatment for HIV?
   Generally no in high-income countries; most guidelines prefer INSTI-based regimens. VIRAMUNE remains used in certain resource-limited settings where cost is a primary consideration.

2. How does the patent status affect VIRAMUNE’s market?
   Patent expirations in many jurisdictions have enabled generic manufacturers to supply affordable versions, expanding access but reducing patent holder revenues.

3. What safety concerns limit VIRAMUNE’s use?
   Hepatotoxicity and hypersensitivity reactions are notable risks, leading to contraindications in patients with high baseline CD4 counts or existing liver issues.

4. Are there ongoing R&D efforts to improve VIRAMUNE?
   No significant investments are publicly announced; the focus has shifted toward newer agents and formulations.

5. What is the outlook for VIRAMUNE in the next decade?
   Likely continued decline in sales outside generic markets, with sustained use in LMICs for as long as affordability and access remain priorities.

---

Sources:

[1] Boehringer Ingelheim Annual Reports and Market Data (2022).