Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate - Generic Drug Details

What are the generic drug sources for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate and what is the scope of freedom to operate?

Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate has three hundred and thirty-one patent family members in fifty-seven countries.

One supplier is listed for this compound.

Summary for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

International Patents:	331
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
DailyMed Link:	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

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

Sponsor	Phase
Gilead Sciences	Phase 3

See all emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate clinical trials

Pharmacology for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ODEFSEY	Tablets	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	200 mg/25 mg/ 25 mg	208351	3	2019-11-05

US Patents and Regulatory Information for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes					Y

Expired US Patents for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016

International Patents for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Country	Patent Number	Title	Estimated Expiration
Croatia	P20161696
Spain	2371442
Croatia	P20040096	HIV INHIBITING PYRIMIDINES DERIVATIVES
Portugal	1301519
Argentina	046812	COMBINACIONES DE UN INHIBIDOR DE LA TRANSCRIPTASA INVERSA NO NUCLEOSIDO (NNRTI) CON CONTENIDO DE PIRIMIDINA CON INHIBIDORES DE LA TRANSCRIPTASA INVERSA

Supplementary Protection Certificates for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	2012C/022	Belgium		PRODUCT NAME: RILPIVIRINE EN TENOFOVIR DISOPROXIL; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001 20111128
1663240	1690062-3	Sweden		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
1419152	CA 2012 00019	Denmark
3808743	PA2022515,C3808743	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA FARMACINIU POZIURIU PRIIMTINOS PRIDETINES RILPIVIRINO DRUSKOS, ISKAITANT RILPIVIRINO HIDROCHLORIDO RUGSTIES DRUSKA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1632232	132016000129226	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA CLORIDRATO O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, EMTRICITABINA E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623

Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Emtricitabine, Rilpivirine Hydrochloride, and Tenofovir Alafenamide Fumarate

Introduction

The combination drug comprising emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide fumarate is a pivotal antiretroviral therapy (ART) used in the treatment of HIV. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this drug combination.

Market Size and Growth Projections

The global market for emtricitabine, rilpivirine, and tenofovir alafenamide is experiencing significant growth. According to market research, the Emtricitabine/Rilpivirine/Tenofovir Alafenamide Sales Market is projected to see substantial expansion from 2023 to 2031, driven by increasing demand for effective ARTs[1].

Segmentation and Geographic Distribution

The market is segmented based on type (tablets), application (hospitals, clinics), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). North America, particularly the US, dominates the market due to broad health insurance coverage, effective HIV awareness programs, and the presence of major pharmaceutical companies[1][2].

Key Drivers of Market Growth

Several factors are driving the growth of this market:

Advancements in Antiretroviral Therapy (ART)

The development of more effective and tolerable ARTs is a significant driver. These advancements have improved treatment accessibility, affordability, and quality of life for HIV patients[2].

Rising HIV Prevalence

Increasing HIV prevalence globally, especially in regions with growing populations and limited healthcare resources, is driving the demand for antiretroviral drugs[2].

Government Funding and Initiatives

Increased government funding and public health initiatives aimed at HIV prevention and treatment are boosting the market. Public-private partnerships also play a crucial role in expanding access to these medications[2].

Expansion of Generic Drugs

The availability and affordability of generic versions of these drugs are expanding the market reach, particularly in developing regions[2].

Market Trends

Combination Therapies

Combination HIV medicines, such as the one comprising emtricitabine, rilpivirine, and tenofovir alafenamide, are gaining momentum due to their better results in managing HIV and related infections[5].

Long-Acting Suppression Antiretroviral Therapy

Research and development of long-acting injectable antiretroviral therapies are expected to revolutionize the market, offering more targeted and effective treatment options[5].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the HIV treatment market, causing disruptions in supply chains but also driving innovation and increased public health awareness. Post-pandemic, the market is expected to see improved access to care, increased innovation, and greater collaboration[2].

Competitive Landscape

The global HIV treatment market is consolidated, with major pharmaceutical companies like Gilead Sciences, ViiV Healthcare, and Merck leading the market. These companies are continuously innovating, with recent developments such as Gilead's FDA application for lenacapavir, a long-acting HIV-1 capsid inhibitor[2].

Financial Performance and Projections

The global HIV treatment market, which includes the emtricitabine, rilpivirine, and tenofovir alafenamide combination, is projected to grow significantly. The market size was approximately $22.38 billion in 2022 and is expected to reach $25.49 billion by 2030, growing at a CAGR of 1.42% from 2023 to 2030[2].

Regional Growth

The Asia Pacific region is anticipated to be the fastest-growing market, driven by highly populated countries like China and India, along with increasing treatment programs and funding from the private sector and healthcare companies[5].

Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as drug resistance, side effects associated with long-term use, and disparities in access to care in different regions[2].

Opportunities

Advances in gene therapy and the development of long-acting injectable therapies offer significant growth opportunities. Public-private partnerships and increased government funding also present avenues for market expansion[2].

Key Players and Their Strategies

Companies like Gilead Sciences are at the forefront of innovation, with products like Biktarvy and ongoing research into new treatments such as lenacapavir. These efforts are crucial in shaping the future of the HIV treatment market[2].

Market Outlook and Future Prospects

The market outlook is positive, with a detailed examination of growth catalysts, constraints, possibilities, and hurdles. The use of frameworks like Porter's 5 Forces and value chain evaluation provides insights into the market's evolutionary path and future prospects[1].

Conclusion

The combination drug of emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide fumarate is poised for significant growth driven by advancements in ART, rising HIV prevalence, and increased government and private sector initiatives. Despite challenges, the market is expected to expand substantially, offering improved treatment options and better patient outcomes.

Key Takeaways

• The Emtricitabine/Rilpivirine/Tenofovir Alafenamide Sales Market is projected to see substantial growth from 2023 to 2031.
• North America, particularly the US, dominates the market due to broad health insurance coverage and the presence of major pharmaceutical companies.
• Advancements in ART, rising HIV prevalence, and government funding are key drivers of market growth.
• Combination therapies and long-acting injectable therapies are trending in the market.
• The Asia Pacific region is expected to be the fastest-growing market.

FAQs

What are the key drivers of the Emtricitabine/Rilpivirine/Tenofovir Alafenamide market?

The key drivers include advancements in ART, rising HIV prevalence, government funding, and the expansion of generic drugs.

Which region is expected to be the fastest-growing market for this drug combination?

The Asia Pacific region is anticipated to be the fastest-growing market due to highly populated countries and increasing treatment programs.

How has the COVID-19 pandemic impacted the HIV treatment market?

The pandemic had a mixed impact, causing disruptions but also driving innovation and increased public health awareness.

What are the challenges faced by the Emtricitabine/Rilpivirine/Tenofovir Alafenamide market?

Challenges include drug resistance, side effects, and disparities in access to care.

Which companies are leading the market for this drug combination?

Major pharmaceutical companies like Gilead Sciences, ViiV Healthcare, and Merck are leading the market.

Cited Sources

1. Market Research Intellect: "Global Emtricitabine/Rilpivirine/Tenofovir Alafenamide Sales Market Size and Forecast".
2. Business Wire: "Global HIV Treatment Market Analysis Report 2023".
3. ClinicalInfo: "Emtricitabine / Rilpivirine / Tenofovir Alafenamide FDA Label".
4. Market Research Intellect: "Global Tenofovir Emtricitabine Combination Drug Market Size And Forecast".
5. Fortune Business Insights: "HIV Drugs Market Size & Growth | Global Report [2024-2032]".