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. Eight 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	42
Patent Applications:	4,845
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
National Institutes of Health (NIH)	Phase 4
Columbia University	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4

See all VIRAMUNE clinical trials

Pharmacology for VIRAMUNE

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

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	TABLET;ORAL	020636-001	Jun 21, 1996		DISCN	Yes	No
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
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
Boehringer Ingelheim	VIRAMUNE	nevirapine	TABLET;ORAL	020636-001	Jun 21, 1996

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/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 VIRAMUNE

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

Country	Patent Number	Title	Estimated Expiration
Australia	5792190
German Democratic Republic	295849	NEUARTIGE 5,11-DIHYDO-6H-DIPYRIDO[3,2-B:2',3'-E]DIAZEPIN-6-ONE UND THIONE UND IHRE ANWENDUNG BEI DER VERHUETUNG BZW. BEHANDLUNG VON AIDS
New Zealand	234261	DIAZEPIN-6-ONE AND -THIONE DERIVATIVES, PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF
South Africa	9004991
Spain	2063202
Spain	2058656

Supplementary Protection Certificates for VIRAMUNE

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

Introduction

Viramune, also known as nevirapine, is an antiretroviral drug used in the treatment of HIV-1 infection. Developed by Boehringer-Ingelheim, it has been a significant player in the global antiretroviral market. Here, we will delve into the market dynamics and financial trajectory of Viramune.

Historical Context and Development

Nevirapine was first approved by the FDA in 1996 and has since been widely used as part of antiretroviral therapy (ART) regimens. Its introduction marked a significant advancement in the treatment of HIV/AIDS, particularly in the late 1990s and early 2000s[4].

Market Size and Share

The global antiretroviral drug market, within which Viramune operates, is substantial. As of 2022, the anti-HIV drug market was valued at approximately $28 billion, with projections indicating continued growth driven by new formulations and treatments[3].

Pricing Strategies

One of the critical factors influencing the market dynamics of Viramune is pricing. Boehringer-Ingelheim has implemented differential pricing strategies to make the drug more accessible in low-income countries. For instance, in 2007, the company reduced the price of nevirapine by 50% in low-income countries and up to 90% in some middle-income countries. This move was aimed at balancing affordability with the need to finance research and development through higher prices in industrialized countries[4].

Impact of Generic Competition

The introduction of generic versions of nevirapine has significantly impacted the market. Generic manufacturers, particularly in India, have offered nevirapine at much lower prices than the original product. For example, the Clinton HIV/AIDS Initiative negotiated prices with Indian generic manufacturers, making nevirapine available for as low as $45 per year, compared to Boehringer-Ingelheim's reduced price of $219 per year in low-income countries[4].

Financial Performance

The financial performance of Viramune is closely tied to the broader antiretroviral market trends and the strategies employed by Boehringer-Ingelheim. Here are some key points:

Revenue Trends

• The revenue from Viramune has been affected by the availability of generic alternatives and the overall decline in prices due to competitive pressures.
• Despite this, the drug has continued to generate significant revenue, albeit at a lower margin compared to its peak.

Cost Savings and Affordability

• The price reductions implemented by Boehringer-Ingelheim have resulted in substantial savings for countries purchasing the drug, especially in low-income and middle-income countries.
• However, these reductions also reflect the challenges faced by pharmaceutical companies in maintaining profitability while ensuring accessibility in developing regions[4].

Market Challenges

Several challenges impact the financial trajectory of Viramune:

Patent and Licensing Issues

• Compulsory licensing in some countries has allowed generic manufacturers to produce nevirapine, reducing the market share and revenue for Boehringer-Ingelheim.
• This has led to debates about the balance between intellectual property rights and public health needs[4].

Competition from New Formulations

• The antiretroviral market is evolving with the introduction of new, more effective formulations such as long-acting (LA) treatments. These innovations could further erode the market share of older drugs like Viramune[3].

Regional Dynamics

The demand and pricing of Viramune vary significantly across different regions:

Low-Income and Middle-Income Countries

• These regions benefit from preferential pricing, making the drug more accessible. However, the prices are still higher than those offered by generic manufacturers[4].

Industrialized Countries

• In these regions, the drug is priced higher to support the research and development costs of pharmaceutical companies.

Future Outlook

The future of Viramune is influenced by several factors:

Generic Competition

• The continued availability of generic versions will likely keep prices low and impact the revenue generated by the original product.

New Therapies and Formulations

• The emergence of new antiretroviral therapies, especially long-acting formulations, may reduce the demand for older drugs like Viramune[3].

Public Health Initiatives

• Initiatives by global health organizations to negotiate lower prices and ensure access to antiretroviral drugs will continue to shape the market dynamics of Viramune.

Key Takeaways

• Pricing Strategies: Differential pricing has been a key strategy to balance affordability and profitability.
• Generic Competition: The availability of generic versions has significantly impacted the market share and revenue of Viramune.
• Regional Dynamics: Pricing and demand vary across different regions, with low-income countries benefiting from preferential pricing.
• Future Outlook: The market will be influenced by new therapies, generic competition, and public health initiatives.

FAQs

What is Viramune used for?

Viramune, or nevirapine, is an antiretroviral drug used in the treatment of HIV-1 infection.

How has the pricing of Viramune changed over time?

Boehringer-Ingelheim has reduced the price of Viramune significantly in low-income and middle-income countries to make it more accessible, while maintaining higher prices in industrialized countries to support research and development.

What impact has generic competition had on Viramune?

Generic versions of nevirapine have reduced the market share and revenue of the original product, making the drug more affordable but also challenging the profitability of Boehringer-Ingelheim.

How does the emergence of new antiretroviral therapies affect Viramune?

The introduction of new, more effective antiretroviral therapies, such as long-acting formulations, is expected to reduce the demand for older drugs like Viramune.

What are the regional differences in the pricing and demand for Viramune?

Pricing and demand for Viramune vary significantly across regions, with low-income countries benefiting from preferential pricing and industrialized countries paying higher prices to support research and development.

Sources

1. Aidsmap - Boehringer cuts nevirapine price for developing world
2. Shionogi Inc. - HIV Business Meeting
3. Grandview Research - Antiviral Drugs Market Size, Share & Growth Report, 2030
4. Globenewswire - Viracta Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update