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-eight 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:	28
Clinical Trials:	187
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
HIV Prevention Trials Network	PHASE2
Abdelrahman Mahmoud	PHASE2
Instituto Mexicano del Seguro Social	PHASE4

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
Aurobindo Pharma	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	090513-001	Jan 26, 2018	AB	RX	No	No
Pharmobedient	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	206436-001	Apr 9, 2018	AB	RX	No	No
Hetero Labs Ltd Iii	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	201806-004	Mar 3, 2025	AB	RX	No	No
Strides Pharma	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	091055-001	Jan 13, 2021	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	021752-003	Mar 10, 2016	6,703,396*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	6,642,245*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	7,402,588*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016	5,935,946*PED

Market Dynamics and Financial Trajectory for Emtricitabine and Tenofovir Disoproxil Fumarate

Last updated: February 20, 2026

What are the key market drivers for emtricitabine and tenofovir disoproxil fumarate (TDF)?

Emtricitabine and TDF are nucleoside reverse transcriptase inhibitors (NRTIs) used primarily for HIV treatment and prophylaxis. Their market growth hinges on several factors:

• HIV/AIDS prevalence: An estimated 38 million people worldwide live with HIV, with new infections continuing in regions like Sub-Saharan Africa and parts of Asia.[1]
• First-line therapy adoption: Both drugs are core components of combination regimens recommended by WHO and CDC.
• Patent expirations: TDF’s patent expired in 2020 in many markets, leading to increased availability of generic versions and price competition.
• Development of biosimilars: Growing pipeline of biosimilars and fixed-dose combinations (FDCs) incorporating these agents expands market options.
• Innovations in treatment: Introduction of newer agents with better safety profiles, such as tenofovir alafenamide (TAF), constrains growth in branded TDF sales.

How has the market evolved over recent years?

The market experienced steady growth from 2018 to 2022, driven by increased global HIV treatment coverage. The global anti-HIV drugs market value was approximately $25 billion in 2022, with TDF and emtricitabine representing a significant share.

• Revenue Breakdown: TDF accounted for roughly 35% of the NRTI segment, with emtricitabine comprising about 15%.[2]
• Market Share Shifts: The entry of TAF-based drugs took market share from TDF formulations due to better renal and bone safety profiles.

Regional Insights:

Region	Market Size (2022, USD millions)	Growth Rate (2018-2022)	Key Drivers
North America	8,600	4%	High treatment coverage, patent protections
Europe	4,500	3.5%	Favorable regulatory environment
Asia-Pacific	7,200	8%	Rising HIV prevalence, generic drug penetration
Africa	2,300	6.5%	Largest patient pool, increasing treatment programs

What are the competitive landscape and patent considerations?

• Patent expirations in key markets have introduced generics, resulting in price drops of up to 50% for TDF-based regimens.
• Major players: Gilead Sciences (with Truvada, Descovy), Teva, Mylan, and Cipla lead in generic production.
• Biosimilar pipeline: Multiple biosimilars of TDF formulations are in late-stage trials, expected to capture >40% of the market share within 3 years of launch.

How do regulatory policies influence market trajectory?

Regulatory agencies, such as FDA and EMA, approve FDCs and generics, influencing product availability and pricing.

• FDA approval for TDF-containing FDCs: Facilitates broad access.
• Pricing policies: Governments in low- and middle-income countries push for generic adoption to lower treatment costs.
• WHO procurement policies: Prioritize cost-effective generics, accelerating market entry.

What financial projections can be made for the next five years?

Market analysts project the combined value of emtricitabine and TDF products to grow at a compound annual growth rate (CAGR) of 3-4% until 2027, influenced by:

• Market saturation in high-income regions hitting maturity.
• Growth continues in emerging markets due to expanding HIV treatment programs.

Projected revenue distribution:

Year	Global Market Size (USD millions)	Notes
2023	27 billion	Slight growth driven by new generic entrants
2025	29 billion	Stable, moderate growth
2027	30-32 billion	Mature market with constrained growth

Key factors affecting future growth:

• Rising use of TAF-based regimens.
• Displacement of TDF by newer agents.
• Increased access to affordable generics.
• Growth of fixed-dose combinations facilitating adherence.

Key Takeaways

• The TDF/emtricitabine market maintained growth through 2022, especially in emerging markets.
• Patent expirations and biosimilar entries are reducing prices and expanding access.
• The market is shifting toward TAF and other newer agents, challenging TDF dominance.
• Growth rate projections suggest a slow but steady expansion in revenue for the next five years.
• Regulatory and policy environments will significantly influence regional market dynamics.

FAQs

1. How does patent expiration impact TDF prices?
Patent expiration allows generics to enter markets, reducing TDF prices by up to 50%, increasing access and sales volume.

2. Are biosimilars a significant threat to branded TDF products?
Yes, biosimilar development pipelines suggest a potential shift in market share within 2-3 years post-approval.

3. What role do emerging markets play in future growth?
Emerging markets represent the highest growth potential, driven by expanding HIV treatment programs and increasing affordability due to generics.

4. How does the adoption of TAF influence the TDF market?
TAF offers better safety profiles, leading to substitution in existing regimens, which constrains TDF’s long-term market expansion.

5. What regulatory challenges could affect market growth?
Delays in biosimilar approvals or restrictive pricing policies could slow market adoption and reduce revenue growth.

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References

[1] UNAIDS. (2022). Global AIDS Update 2022.
[2] MarketWatch. (2023). Anti-HIV Drugs Market Size and Forecast.