Emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

What are the generic sources for emtricitabine; tenofovir disoproxil fumarate and what is the scope of patent protection?

Emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in three branded drugs marketed by Hetero Labs Ltd Iii, Amneal Pharms Co, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Macleods Pharms Ltd, Pharmobedient, Strides Pharma, Teva Pharms Usa, Zydus Pharms, and Gilead, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for emtricitabine; tenofovir disoproxil fumarate

US Patents:	0
Tradenames:	3
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	29
Clinical Trials:	185
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for emtricitabine; tenofovir disoproxil fumarate
DailyMed Link:	emtricitabine; tenofovir disoproxil fumarate at DailyMed

Recent Clinical Trials for emtricitabine; tenofovir disoproxil fumarate

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

Sponsor	Phase
Instituto Mexicano del Seguro Social	PHASE4
Instituto Mexicano del Seguro Social	PHASE3
Jos Antonio Mata Marn	PHASE3

See all emtricitabine; tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Application No.	Strength	Dosage Form
		200MG; 300MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for emtricitabine; tenofovir disoproxil 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 disoproxil 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 DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRUVADA	Tablets	emtricitabine; tenofovir disoproxil fumarate	100 mg/150 mg 133 mg/200 mg 167 mg/250 mg	021752	1	2017-05-19
TRUVADA	Tablets	emtricitabine; tenofovir disoproxil fumarate	200 mg/300 mg	021752	1	2008-09-26

US Patents and Regulatory Information for emtricitabine; tenofovir disoproxil fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	208740-001	Jun 16, 2021		DISCN	No	No
Zydus Pharms	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	212689-004	Jul 1, 2021	AB	RX	No	No
Amneal Pharms Co	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209721-001	Aug 22, 2018	AB	RX	No	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes
Aurobindo Pharma Ltd	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	211640-002	Mar 9, 2023	AB	RX	No	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	AB	RX	Yes	No
Amneal Pharms Co	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209721-002	Aug 22, 2018	AB	RX	No	No

Expired US Patents for emtricitabine; tenofovir disoproxil fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	5,922,695*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	5,814,639*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016	6,642,245*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	5,977,089*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	8,592,397
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	8,716,264
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016	6,642,245*PED

Market Dynamics and Financial Trajectory for Emtricitabine and Tenofovir Disoproxil Fumarate

Last updated: July 30, 2025

Overview

Emtricitabine (FTC) and Tenofovir Disoproxil Fumarate (TDF) are cornerstone antiretroviral agents used in the management of HIV/AIDS. Their combined use in fixed-dose formulations, notably Truvada and Descovy, has revolutionized HIV treatment paradigms. This review delineates current market dynamics, competitive landscape, regulatory environment, and financial trajectory of these drugs, providing strategic insights for stakeholders.

Market Landscape

The global HIV therapeutics market, valued at approximately USD 20 billion in 2022, is characterized by robust growth driven by expanding patient populations, novel combination therapies, and increased access in emerging markets [1]. Emtricitabine and TDF, due to their proven efficacy, safety profile, and convenience, constitute a significant share of this market, especially in fixed-dose combination (FDC) formulations.

Market Drivers

1. Rising HIV Prevalence: According to UNAIDS, over 38 million individuals worldwide are living with HIV, with sub-Saharan Africa bearing the highest burden. The need for effective, long-term antiretroviral therapy (ART) sustains demand for FTC and TDF-based regimens [2].

2. Treatment Guidelines and Policy Changes: The World Health Organization (WHO) recommends TDF-based FDCs as first-line therapy, fueling uptake. Moreover, shifts favorting simplified regimens enhance the role of these drugs [3].

3. Patent Expiry and Generic Competition: The expiration of key patents in major markets induces price competition, increasing accessibility and volumetric sales.

4. Adoption in Pre-Exposure Prophylaxis (PrEP): The approval and growing implementation of PrEP, especially with Truvada, expands the utilization scope of FTC/TDF beyond treatment to prevention.

Competitive Landscape

While Gilead Sciences remains dominant as the primary manufacturer of FTC/TDF-based products, generic manufacturers have entered multiple markets post-patent expiration, intensifying competition. Key players include Teva Pharmaceuticals, Mylan, and Cipla, which offer cost-effective generics, particularly in emerging economies.

Regulatory Environment

Regulatory agencies like the FDA and EMA continuously evaluate efficacy and safety data, approving FDCs and newer alternatives such as tenofovir alafenamide (TAF) to enhance safety profiles. These developments influence market preference, with a gradual shift towards TAF-comprising regimens due to reduced renal and bone toxicity.

Financial Trajectory

Gilead's revenue from FTC/TDF containing products peaked at approximately USD 9 billion in 2018 but has experienced a gradual decline due to generic competition and market saturation [4]. Nonetheless, the overall HIV antiviral segment remains profitable, driven by high-volume sales, especially in developing nations.

The advent of TAF-based formulations and long-acting injectables is poised to reshape revenue streams over the coming decade. For instance, the launch of Gilead’s Biktarvy and the rollout of Cabotegravir injectables demonstrate strategic innovation aimed at sustaining market dominance and revenue growth.

Pricing and Market Penetration

Pricing strategies significantly influence market dynamics. The availability of low-cost generics in emerging markets boosts access but simultaneously pressures branded sales. In contrast, branded formulations retain premiums in developed markets. The balance impacts revenue trajectories, especially as patent expiries threaten branded product dominance.

Emerging Trends and Future Outlook

• Shift Toward TAF: With better safety profiles, TAF replacing TDF is expected to gradually displace older formulations, impacting market shares and revenues. Gilead’s newer TAF-based products like Descovy are gaining traction post-approval.

• Long-Acting and Depot Formulations: Long-acting injectables like Cabotegravir provide a transformative opportunity, potentially redefining treatment adherence and market dynamics.

• Regulatory and Patent Developments: Patent litigations and extensions may temporarily sustain exclusivity, but inevitable patent cliffs will impose additional competitive pressures.

• Market Expansion in Developing Countries: Enhanced access programs, generic proliferation, and tiered pricing will catalyze volume-driven growth in low-income regions.

Financial Prospects and Strategic Implications

While the near-term revenue from FTC/TDF products may plateau due to generic competition, the pipeline of next-generation formulations and diversifying indications bolster long-term growth prospects. Firms investing in formulations suitable for PrEP, long-acting delivery, and combination therapies stand to capitalize on both expanding markets and evolving patient needs.

Key Factors Influencing Financial Trajectory:

• Patent Expirations and Generic Competition: Critical in determining revenue trajectories; proactive patent strategies and licensing can mitigate losses.

• Pipeline Innovation: Investment in TAF-based and long-acting therapies sustains revenue streams amid market saturation.

• Market Expansion Strategies: Entering emerging markets with affordable generics and partnerships enhances volume.

• Regulatory Approvals: Accelerated approvals and expanded indications increase potential sales.

Conclusion

The market dynamics for Emtricitabine and Tenofovir Disoproxil Fumarate are shaped by evolving treatment guidelines, patent expiries, and technological innovation. While traditional formulations face declining revenues post-patent expiry, sustained growth hinges on innovating with safer, longer-acting, and broader-spectrum therapies, alongside expanding access globally. Companies that strategically navigate these transitions will shape the financial trajectory of these foundational HIV agents.

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Key Takeaways

• The global HIV therapy market sustains high growth driven by prevalence, guideline updates, and access initiatives.
• Patent expiries intensify generic competition, impacting branded revenues but expanding market reach through lower-cost alternatives.
• Transition toward TAF-based regimens and long-acting formulations offers promising revenue opportunities.
• Market expansion in emerging economies is crucial for sustained volumetric growth.
• Strategic focus on pipeline innovation and market adaptation will determine long-term financial success.

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FAQs

1. How does patent expiry influence the revenue of Emtricitabine and TDF?
   Generic entry post-patent expiry significantly reduces product prices, leading to revenue decline for branded manufacturers but broader access and increased volume in global markets.

2. What are the primary market drivers for FTC/TDF-based therapies?
   Rising HIV prevalence, adherence to treatment guidelines favoring TDF, regulatory approvals of PrEP, and the evolution of combination therapies drive demand.

3. How are newer formulations affecting the market landscape?
   TAF-based formulations and long-acting injectables are capturing market share due to improved safety profiles and convenience, potentially replacing older TDF-based therapies.

4. What role does emerging markets play in the future of FTC/TDF sales?
   These markets provide growth opportunities through increased access, generic competition, and strategic pricing, compensating for saturation in developed regions.

5. What are the key factors determining the long-term financial outlook for these drugs?
   Pipeline innovation, patent lifecycle management, regulatory environment, market expansion strategies, and shifting treatment paradigms are fundamental.

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Sources

1. Institute for Health Metrics and Evaluation, 2022 Global HIV Report
2. UNAIDS Global AIDS Update 2022
3. WHO Consolidated Guidelines on HIV Prevention, Diagnosis, Treatment and Care, 2021
4. Gilead Sciences Financial Reports, 2020-2022