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. Eight 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
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 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/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 XR

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I419716
Singapore	54197	Dipyridodiazepines
Netherlands	990022
Japan	H0363276	NOVEL 5,11-DIHYDRO-6H-DIPYRIDO(3,2-B:2',3'-E) (1,4) DIAZEPINE-6-ONE AND PHARMACEUTICAL COMPO- SITION CONTAINING COMPOUND THEREOF FOR PREVENTING AND TREATING AIDS
Chile	2008001678	Forma de dosificación farmacéutica de liberacion prolongada en forma de comprimido, que consiste de nevirapina anhidra, hipromelosa, lactosa monohidrato y estearato de magnesio; y su procedimiento de preparación, util para el tratamiento de una infeccion por vih-1.

Supplementary Protection Certificates for VIRAMUNE XR

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	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	990022	Netherlands		990022, 20101116, EXPIRES: 20121222
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 Experimental

Market Dynamics and Financial Trajectory for VIRAMUNE XR

Introduction

VIRAMUNE XR, the extended-release formulation of nevirapine, is a crucial component in the treatment of HIV-1 infection. This article delves into the market dynamics and financial trajectory of VIRAMUNE XR, highlighting its efficacy, safety profile, and market impact.

Efficacy and Safety Profile

VIRAMUNE XR has been extensively studied in clinical trials to compare its efficacy and safety with the immediate-release formulation, VIRAMUNE IR. The VERxVE trial, which involved 1,011 treatment-naïve patients, demonstrated that VIRAMUNE XR is non-inferior to VIRAMUNE IR in terms of efficacy and safety. The trial showed a virologic response rate of 81.0% for VIRAMUNE XR compared to 75.9% for VIRAMUNE IR at week 48, with a similar adverse event profile but numerically fewer adverse events for VIRAMUNE XR[1][5].

Market Positioning

Convenience and Compliance

One of the key advantages of VIRAMUNE XR is its once-daily dosing regimen, which can significantly improve patient compliance compared to the twice-daily regimen of VIRAMUNE IR. This convenience can lead to better therapeutic outcomes and increased patient satisfaction[1][5].

Competitive Landscape

The antiviral drugs market, particularly for HIV treatments, is highly competitive. However, VIRAMUNE XR's unique dosing schedule and comparable efficacy and safety profile position it favorably in the market. The global antiviral drugs market is expected to grow, driven by increasing cases of viral infections and the need for innovative treatments[3].

Financial Trajectory

Revenue and Market Share

While specific financial data for VIRAMUNE XR is not readily available, the overall performance of antiretroviral therapies can provide insights. The antiviral drugs market is projected to reach USD 50.02 billion by 2030, growing at a CAGR of 3.4% during the forecast period. This growth is driven by the rising incidence of viral infections and the development of new and improved drug formulations[3].

Pharmaceutical Company Performance

Boehringer Ingelheim, the manufacturer of VIRAMUNE XR, does not release separate financial data for this specific drug. However, the company's overall financial performance can indicate the drug's contribution. Pharmaceutical companies like Boehringer Ingelheim often see revenue growth driven by key products, including antiviral medications. For instance, companies like Eli Lilly, which reports on various pharmaceutical products, saw significant revenue growth in 2021 driven by key products, although VIRAMUNE XR is not specifically mentioned[2].

Regulatory Considerations

Indications and Usage

VIRAMUNE XR is indicated for the combination antiretroviral treatment of HIV-1 infection in adults. It is contraindicated for use in post-exposure prophylaxis regimens and has specific initiation criteria based on CD4+ cell counts. The drug requires a 14-day lead-in period with immediate-release VIRAMUNE to reduce the risk of rash and other adverse events[4][5].

Safety and Adverse Events

The safety profile of VIRAMUNE XR includes a lower incidence of hepatic events and symptomatic hepatic events compared to VIRAMUNE IR. However, it is associated with rash, diarrhea, headache, and other adverse events. The incidence of GRADE 3 or 4 ALT/AST elevation is comparable between the two formulations[1][5].

Market Drivers and Barriers

Drivers

• Increasing Incidence of HIV: The ongoing need for effective HIV treatments drives the demand for antiretroviral therapies like VIRAMUNE XR.
• Convenience and Compliance: The once-daily dosing regimen of VIRAMUNE XR enhances patient compliance, which is a significant market driver.
• Global Health Initiatives: Efforts to combat HIV/AIDS globally increase the demand for antiretroviral drugs[3].

Barriers

• High R&D Costs: The high costs associated with the research and development of antiviral drugs can limit market growth.
• Healthcare Costs: Rising healthcare costs and preventive measures against viral infections can also hinder market growth[3].

Key Takeaways

• VIRAMUNE XR offers a convenient once-daily dosing regimen, improving patient compliance.
• The drug has been shown to be non-inferior to VIRAMUNE IR in terms of efficacy and safety.
• The antiviral drugs market is expected to grow, driven by increasing cases of viral infections.
• Regulatory considerations, including specific initiation criteria and safety profiles, are crucial for the drug's use.
• Market drivers include the increasing incidence of HIV and global health initiatives, while high R&D costs and healthcare expenses are significant barriers.

FAQs

What is VIRAMUNE XR used for?

VIRAMUNE XR is used for the combination antiretroviral treatment of HIV-1 infection in adults.

How does VIRAMUNE XR differ from VIRAMUNE IR?

VIRAMUNE XR is an extended-release formulation that allows for once-daily dosing, whereas VIRAMUNE IR requires twice-daily dosing.

What are the key findings of the VERxVE trial?

The VERxVE trial demonstrated that VIRAMUNE XR is non-inferior to VIRAMUNE IR in efficacy and safety, with a similar adverse event profile but numerically fewer adverse events for VIRAMUNE XR.

What are the common adverse events associated with VIRAMUNE XR?

Common adverse events include rash, diarrhea, headache, and hepatic events.

Is VIRAMUNE XR approved for pediatric use?

Yes, VIRAMUNE XR is approved for use in pediatric patients aged 6 to less than 18 years, based on pharmacokinetic, safety, and efficacy data[5].

Sources

1. Comparison of 48 week efficacy and safety of 400mg QD nevirapine XR and 200mg BID nevirapine IR in treatment-naïve patients with HIV-1. Natap.org.
2. Lilly Reports Solid Fourth-Quarter and Full-Year 2021 Financial Results. Investor.lilly.com.
3. Antiviral Drugs Market Analysis 2022-2030. BioSpace.
4. VIRAMUNE XR - accessdata.fda.gov. Accessdata.fda.gov.
5. VIRAMUNE XR® (nevirapine) extended-release tablets, for oral use. Boehringer-ingelheim.com.