EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details

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

Emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc and Apotex, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Emtricitabine; tenofovir alafenamide fumarate has one hundred and thirty-two patent family members in fifty countries.

One supplier is listed for this compound.

Summary for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	132
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	41
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
DailyMed Link:	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed

Recent Clinical Trials for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

Sponsor	Phase
ANRS, Emerging Infectious Diseases	Phase 3
Assistance Publique - Hôpitaux de Paris, FRANCE	Phase 3
Ministry of Health, Thailand	Phase 3

See all EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Pharmacology for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

Anatomical Therapeutic Chemical (ATC) Classes for EMTRICITABINE; 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

Paragraph IV (Patent) Challenges for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DESCOVY	Tablets	emtricitabine; tenofovir alafenamide fumarate	120 mg/15 mg	208215	1	2022-10-31
DESCOVY	Tablets	emtricitabine; tenofovir alafenamide fumarate	200 mg/25 mg	208215	6	2019-11-05

US Patents and Regulatory Information for EMTRICITABINE; 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	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016		RX	Yes	Yes	9,296,769*PED				Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No	7,390,791*PED				Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016		RX	Yes	Yes	7,390,791*PED				Y

Expired US Patents for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	7,803,788
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	5,814,639*PED
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	6,703,396*PED
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	6,642,245*PED

International Patents for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Country	Patent Number	Title	Estimated Expiration
Japan	2015038149	テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Canada	2893174
Montenegro	02612	TENOFOVIR ALAFENAMID HEMIFUMARAT (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Colombia	6880063	Hemifumarato de tenofovir alafenamida

Supplementary Protection Certificates for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	PA2016009,C1301519	Lithuania		PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS ARBA JO DRUSKA ARBA SOLVATAS, YPATINGAI TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
1301519	122016000024	Germany		PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
0915894	05C0032	France		PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
1663240	1590055-8	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLYACCEPTABLE SALT OF RILPIVIRINE, INICLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Emtricitabine and Tenofovir Alafenamide Fumarate

Introduction

Emtricitabine and tenofovir alafenamide fumarate (TAF) are crucial components in the treatment and prevention of HIV, particularly when combined in formulations like Descovy (TAF/emtricitabine) and other co-formulated therapies. This article delves into the market dynamics, financial trajectory, and key factors influencing the market for these drugs.

Market Growth and Projections

The market for emtricitabine and TAF has experienced significant growth in recent years and is projected to continue this upward trend. From 2023 to 2031, the market is expected to undergo substantial expansion, driven by increasing demand for effective and safer HIV treatments and preexposure prophylaxis (PrEP)[1][3].

Market Segmentation

The market is segmented based on several factors, including:

• Type: This includes different packaging options such as 1 bottle/box and 3 bottles/box.
• Application: The primary applications are in hospitals, clinics, drug centers, and other healthcare settings.
• Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][3].

Key Drivers

Several factors drive the growth of this market:

• Increasing Demand for HIV Treatment and PrEP: The rising incidence of HIV and the growing awareness of PrEP have led to an increased demand for effective and safe antiretroviral therapies.
• Superior Safety Profile of TAF: TAF offers a more favorable safety profile compared to its predecessor, tenofovir disoproxil fumarate (TDF), particularly in terms of renal and bone health[2][4].
• Regulatory Approvals: Recent approvals, such as the FDA approval of Descovy for HIV prophylaxis, have expanded the market for TAF/emtricitabine formulations[2].

Financial Trajectory

Pricing and Cost-Effectiveness

The pricing of TAF/emtricitabine formulations is a critical aspect of the market. Gilead, the manufacturer, has priced Descovy competitively with other branded formulations, with an Average Wholesale Price (AWP) of $37,118 per patient per year. However, cost-effectiveness analyses suggest that the premium for TAF over generic TDF should be limited, especially considering the modest clinical benefits of TAF over TDF. For instance, a study suggested that an annual premium of up to $1,010 over the current AWP for TDF-based formulations could be justified, but this figure may decrease with the availability of generic TDF[2][5].

Market Size and Revenue

The market size for emtricitabine and TAF is substantial and growing. The market is expected to reach significant revenue milestones during the forecast period, measured in USD million. The detailed reports on these markets provide comprehensive analyses of revenue growth across various segments and geographical regions[1][3].

Competitive Scenario

The competitive landscape of the emtricitabine and TAF market includes several key players:

• Gilead Sciences: As the primary manufacturer of TAF and emtricitabine formulations, Gilead plays a dominant role.
• Bristol-Myers Squibb: Another major player in the antiretroviral market.
• Janssen Pharmaceutica (Johnson & Johnson): Known for their contributions to HIV treatment.
• Biocon Limited: An emerging player in the pharmaceutical industry.
• Other Companies: Such as Flamingo Pharmaceuticals Limited, IPCA Laboratories, and Thermo Fisher Scientific[1].

Challenges and Opportunities

Challenges

• Generic Competition: The expiration of patents for TDF and the availability of generic versions pose a significant challenge to branded TAF formulations. Generic TDF/FTC has already started to gain market share, which could impact the pricing and market share of branded TAF/emtricitabine[2][4].
• Cost Containment: There is a need for judicious cost containment, as the high costs of branded formulations can be a barrier to access, especially in resource-limited settings[2][5].

Opportunities

• Expanding Market: The growing awareness and demand for PrEP and HIV treatment present a significant opportunity for market expansion.
• Emerging Markets: Geographical regions such as Asia-Pacific and South America offer untapped potential for growth[1][3].

Consumer Behavior and Preferences

Consumer behavior is influenced by several factors:

• Safety and Efficacy: Patients and healthcare providers prefer formulations with better safety profiles, such as TAF/emtricitabine, due to its reduced toxicity compared to TDF[2][4].
• Cost Considerations: The high cost of branded formulations can influence prescribing choices, with generic options becoming more attractive as they become available[4][5].

Economic, Political, and Social Landscapes

The market is also influenced by broader economic, political, and social factors:

• Healthcare Policies: Changes in healthcare policies and reimbursement structures can impact the market.
• Economic Conditions: National GDP and economic stability of regions can affect market growth.
• Social Awareness: Increasing awareness about HIV and PrEP drives demand for these medications[1][3].

Key Takeaways

• The market for emtricitabine and TAF is experiencing robust growth driven by increasing demand and a superior safety profile.
• The financial trajectory is influenced by pricing strategies, cost-effectiveness analyses, and the impact of generic competition.
• Key players dominate the market, but emerging companies are also making significant contributions.
• Challenges include generic competition and cost containment, while opportunities lie in expanding markets and emerging regions.

FAQs

What is the expected growth rate of the emtricitabine and TAF market from 2023 to 2031?

The market is projected to experience significant and sustained expansion, with robust growth rates anticipated during the forecast period[1][3].

How does the pricing of TAF/emtricitabine formulations compare to TDF/emtricitabine?

TAF/emtricitabine formulations are priced competitively, but cost-effectiveness analyses suggest that the premium over generic TDF should be limited to around $1,010 per year[2][5].

Which companies are the key players in the emtricitabine and TAF market?

Key players include Gilead Sciences, Bristol-Myers Squibb, Janssen Pharmaceutica (Johnson & Johnson), Biocon Limited, and others[1].

What are the main challenges facing the branded TAF/emtricitabine market?

The main challenges include generic competition, especially as TDF patents expire, and the need for cost containment due to the high costs of branded formulations[2][4].

How does the safety profile of TAF compare to TDF?

TAF has a more favorable safety profile compared to TDF, particularly in terms of renal and bone health, achieving higher intracellular levels of tenofovir at lower plasma levels[2][4].

Sources

1. Market Research Intellect: Global Emtricitabine And Tenofovir Alafenamide Fumarate Tablets Market.
2. AIDSmap: Tenofovir alafenamide fumarate at what price? No more than $1000 per year above existing tenofovir.
3. Market Research Intellect: Global Emtricitabine/Rilpivirine/Tenofovir Alafenamide Sales Market.
4. AIDS: Trends in HIV preexposure prophylaxis utilization and unnecessary spending.
5. NATAP: Comparative Pricing of Branded Tenofovir Alafenamide–Emtricitabine for HIV Preexposure Prophylaxis.