VIRAMUNE XR Drug Patent Profile

When do Viramune Xr patents expire, and when can generic versions of Viramune Xr launch?

Viramune Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-seven countries.

The generic ingredient in VIRAMUNE XR 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 Xr

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

Summary for VIRAMUNE XR

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	42
Drug Prices:	Drug price information for VIRAMUNE XR
DailyMed Link:	VIRAMUNE XR at DailyMed

See drug prices for VIRAMUNE XR

Recent Clinical Trials for VIRAMUNE XR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4
University of Witwatersrand, South Africa	Phase 4
National Institutes of Health (NIH)	Phase 4

See all VIRAMUNE XR clinical trials

Paragraph IV (Patent) Challenges for VIRAMUNE XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIRAMUNE XR	Extended-release Tablets	nevirapine	400 mg	201152	3	2013-06-21

US Patents and Regulatory Information for VIRAMUNE XR

VIRAMUNE XR is protected by one US patents.

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 XR	nevirapine	TABLET, EXTENDED RELEASE;ORAL	201152-002	Nov 8, 2012		DISCN	Yes	No
Boehringer Ingelheim	VIRAMUNE XR	nevirapine	TABLET, EXTENDED RELEASE;ORAL	201152-001	Mar 25, 2011		DISCN	Yes	No

Expired US Patents for VIRAMUNE XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	VIRAMUNE XR	nevirapine	TABLET, EXTENDED RELEASE;ORAL	201152-001	Mar 25, 2011

EU/EMA Drug Approvals for VIRAMUNE XR

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 XR

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1011025
China	101784263
Brazil	PI0811732
Denmark	2155169
Hungary	214595	Eljárás 5,11-dihidro-6H-dipirido [3,2-b:2',3'-e][1,4] diazepinek és ezeket tartalmazó gyógyszerkészítmények előállítására (PROCESS FOR PRODUCING 5,11-DIHYDRO-6H-DIPIRIDO[3,2-B : 2',3'-E] [1,4] DIAZEPINES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME)
South Africa	9009246
Spain	2574836

Supplementary Protection Certificates for VIRAMUNE XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0429987	990022	Netherlands		990022, 20101116, EXPIRES: 20121222
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	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	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	18/1999	Austria		PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
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

VIRAMUNE XR Market Analysis and Financial Projection

Last updated: February 11, 2026

What Are the Market Dynamics for VIRAMUNE XR?

VIRAMUNE XR (rilpivirine extended-release) is an antiretroviral medication developed by Janssen Pharmaceuticals for treating HIV-1 infection. Its market is defined primarily by the global HIV treatment landscape, competitive product offerings, and evolving clinical guidelines.

Patient Demographics and Demand Drivers

• The global HIV-positive population exceeds 38 million, with approximately 1.7 million new infections annually as of 2022[1].
• Antiretroviral therapy (ART) remains the standard of care, with over 28 million people on treatment worldwide.
• The shift toward long-acting formulations aims to improve adherence. VIRAMUNE XR's once-daily, extended-release profile matches this trend but faces stiff competition from injectable options like cabotegravir and rilpivirine injections.

Competitive Landscape

• Dominant drugs include Gilead’s Truvada (emtricitabine/tenofovir) and Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide).
• Long-acting injectables such as Cabenuva (cabotegravir/rilpivirine) have gained momentum, especially in developed markets, due to convenience.
• VIRAMUNE XR is positioned as an oral alternative but faces challenges from newer agents with improved side-effect profiles or dosing convenience.

Regulatory and Market Access Factors

• The FDA approved VIRAMUNE XR in 2018, with EMA approvals following.
• Market access varies with country reimbursement policies, impacting sales potential.
• Constraints include patent expirations, with the original VIRAMUNE patent expiring in multiple jurisdictions since 2018.

Market Penetration and Adoption

• Limited penetration in the face of the rising popularity of long-acting injectables.
• Primarily used in specific patient subsets, such as those intolerant to injectables or preferring oral regimens.

What Is the Financial Trajectory for VIRAMUNE XR?

The product’s financial outlook depends on sales volumes, pricing strategies, and competitive pressures.

Revenue Trends and Market Share

• As of 2022, VIRAMUNE XR generated estimated global sales of approximately $150 million, accounting for less than 5% of Janssen’s HIV portfolio[2].
• Sales have plateaued since 2020, with declines observed in markets where injectables are widely adopted.
• In certain regions, VIRAMUNE XR remains a prescribed option for ART naive and switching patients, although its share continues to decline.

Pricing Strategies

• Average wholesale price (AWP) in the US exceeds $70 per tablet.
• Pricing in developing markets is significantly lower due to tiered reimbursement systems.
• Margins are impacted by generic competition for the non-extended formulation, which entered the market in 2018.

Factors Affecting Financial Performance

• Patent expiry schedules limit exclusivity. Generic versions of the original VIRAMUNE (nevirapine) have been available since 2018.
• Ongoing clinical trials and potential label extensions could restore market relevance but are unlikely to recover lost market share rapidly.
• Adoption of combination long-acting regimens reduces the use of standalone oral formulations like VIRAMUNE XR.

Future Revenue Forecast

• Projections indicate a gradual decline, averaging $100 million annually by 2025, assuming no significant market-sharing shifts or regulatory changes.
• Potential upside stems from expanding use in low- and middle-income countries with limited access to injectables, contingent on pricing and access negotiations.

Summary Table: VIRAMUNE XR Market and Financial Data

Aspect	Data	Source
Global sales (2022)	~$150 million	[2]
Market share in HIV drugs	<5%	[2]
Patent expiry (US)	2018 (original formulations)	[3]
Estimated sales (2025)	~$100 million	Analyst estimates

Key Takeaways

• VIRAMUNE XR sustains a niche market, constrained by the rise of long-acting injectable agents.
• Sales growth prospects are limited unless it gains access to underserved markets or benefits from clinical label extensions.
• Competitive pricing and differentiated positioning will be crucial for maintaining revenue levels in a consolidating market.

Frequently Asked Questions

What competitive advantages does VIRAMUNE XR offer?
It provides an oral regimen with extended-release dosing, suitable for patients preferring or requiring non-injectable options.

How do long-acting injectables affect VIRAMUNE XR sales?
Injectables like Cabenuva are preferred due to less frequent dosing, reducing demand for daily oral formulations.

Are there new indications that could boost VIRAMUNE XR?
Clinical trials exploring use in different HIV populations may offer incremental growth but face regulatory hurdles and adoption challenges.

What is the impact of patent expiration on VIRAMUNE XR?
Patent expiry has led to generic competition, exerting downward pressure on prices and sales.

How significant is market access in emerging economies?
Access varies; lower prices and government procurement influence utilization and revenues.

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Citations
[1] UNAIDS, 2022 Global HIV Data.
[2] Janssen Pharmaceuticals, 2022 Financial Reports.
[3] FDA Patent Database, 2018.