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

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

Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc and Mylan, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate has fifty-five patent family members in thirty-seven countries.

Two suppliers are listed for this compound.

Summary for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

International Patents:	55
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
DailyMed Link:	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate at DailyMed

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

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

Sponsor	Phase
Janssen Pharmaceutical K.K.	Phase 4
Azienda Ospedaliera San Gerardo di Monza	Phase 4
Gilead Sciences	Phase 4

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

Pharmacology for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil 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 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

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 DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMPLERA	Tablets	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	200 mg/25 mg/ 300 mg	202123	1	2015-05-20

US Patents and Regulatory Information for emtricitabine; rilpivirine hydrochloride; 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
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	AB	RX	Yes	Yes	10,857,102		Y
Mylan	EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	208452-001	May 20, 2025	AB	RX	No	No

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	8,841,310
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	8,080,551
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	5,814,639*PED
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	7,067,522
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	8,101,629
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	9,457,036
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	6,043,230*PED

International Patents for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

Country	Patent Number	Title	Estimated Expiration
Ukraine	114075	БАГАТОШАРОВА ТАБЛЕТКА, ЩО МІСТИТЬ РИЛПІВІРИН HCl, ЕМТРИЦИТАБІН І ТЕНОФОВІРУ ДИЗОПРОКСИЛФУМАРАТ
New Zealand	610729	Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate
Costa Rica	20130293
Cyprus	1116115
Singapore	10201509521W	THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Chile	2013001402
Serbia	53691	TERAPEUTSKE KOMPOZICIJE KOJE SADRŽE RILPIVIRIN HCL I TENOVOFIR DIZOPROKSIL FUMARAT (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRIN HCL AND TENOVOFIR DISOPROXIL FUMARATE)

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1632232	300852	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
3808743	CA 2022 00035	Denmark		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128
1663240	SPC/GB15/064	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTERED: UK EU/1/11/737/001-002 20111128
3808743	LUC00275	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU D'UNE FORME THERAPEUTIQUEMENT EQUIVALENTE DE CELLE-CI PROTEGEE PAR LE BREVET DE BASE, TELLE QU'UN SEL D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE, ET D'EMTRICITABINE; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001-002 20111128
1663240	1590057-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
0915894	08C0020	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
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

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

Last updated: February 19, 2026

This analysis covers the current market position, growth drivers, competitive landscape, and financial trends for emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate (TDF). These drugs are key components in antiretroviral therapy (ART) for HIV treatment.

Market Overview

The combination of these drugs forms the backbone of many first-line regimens for HIV. Gilead Sciences dominates the market with its branded products like Truvada and Descovy, though generic versions are entering markets.

Estimated global HIV treatment market (2022): $29 billion, projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% through 2027 [1].

Key drugs:

• Tenofovir disoproxil fumarate (TDF): Widely used nucleotide reverse transcriptase inhibitor (NRTI)
• Emtricitabine: NRTI often combined with TDF
• Rilpivirine: Non-nucleoside reverse transcriptase inhibitor (NNRTI) used in flexible regimens

Market Drivers

• HIV prevalence: 38 million globally; steady growth influences drug demand.
• Regimen innovations: Transition towards integrase inhibitors (e.g., dolutegravir) affects market share.
• Patent expiries and generics: Key for price declines; TDF patents expired in 2020 in several countries, prompting generic entry.
• Resistance issues: Resistance to specific drugs propels demand for alternative combinations.

Competitive Landscape

Company	Key Products	Market Share (2022)	Notable Moves
Gilead Sciences	Truvada, Descovy, Odefsey	~70%	Stronghold with multiple authorized regimens
Teva Pharmaceuticals	Teva’s generic TDF/FTC products	~10%	Gaining ground via price competitiveness
Mylan	Generic formulations	~8%	Focus on emerging markets
Others	Various generics and biosimilars	<12%	Entry into low-cost markets

Note: Market share estimates are approximate, based on sales data from IQVIA (2022).

Financial Trajectory

Revenue Trends

• Gilead’s HIV franchise: Revenue peaked around $13 billion in 2019. Recent years show a decline, attributed to patent expiries and increased generic competition.

• Patent expiries:

  • TDF patent expired in the US in 2020, leading to a significant decline in branded sales.
  • Descovy remains under patent until at least 2028, maintaining higher margins.

• Generics growth:
  Begins in 2020 for TDF, expected to capture up to 50% of the market by 2025, reducing originator revenues.

Pricing Dynamics

• Branded prices (~$20,000/year per patient) have declined by approximately 30% since 2018 due to generic competition.
• Average wholesale prices (AWP) for generics fall below $10,000, boosting access in lower-income markets.

R&D Investment and Pipeline

• Pipeline focus: New fixed-dose combinations (FDCs) with improved tolerability and less resistance.
• Gene editing and long-acting injectables are on the horizon, potentially disrupting current revenue streams.

Market Outlook

• Short-term: Revenue decline in TDF-based products continues as patents lapse; generic proliferation accelerates.

• Long-term: Shift towards integrase inhibitors and long-acting injectables could reduce reliance on TDF, emtricitabine, and rilpivirine.

• Innovations: Novartis’s long-acting cabotegravir injections are gaining market share, threatening traditional TDF/FTC/RPV regimens.

Key Takeaways

• The market for emtricitabine, rilpivirine, and TDF is mature, with declining revenues due to patent expiries and generic competition.
• Gilead’s revenues from these drugs are decreasing, though pipeline investments aim to sustain growth via new formulations and delivery systems.
• The shift toward newer drug classes and long-acting formulations presents both risks and opportunities.
• Pricing pressures are intensifying, especially in emerging markets.
• The healthcare landscape toward HIV treatment is increasingly influenced by regulatory, patent, and market entry dynamics.

FAQs

Q1: What impact will generic versions of TDF have on the market?
Generics are expected to reduce revenues for branded TDF products by up to 50% by 2025, pressuring margins and leading to increased competition in both low- and middle-income markets.

Q2: How are newer drugs affecting the demand for emtricitabine and rilpivirine?
Long-acting injectables and integrase inhibitors are gaining popularity, potentially displacing traditional pills, especially in adherence-challenged populations.

Q3: What opportunities exist for companies in this market?
Developing long-acting formulations, improving resistance profiles, and expanding access through reduced pricing and partnerships in emerging markets.

Q4: Are regulatory policies influencing market dynamics?
Yes. Patent laws and approval pathways for generics and biosimilars significantly impact timing and competition levels.

Q5: Which regions are most impacted by these market changes?
High-income countries see rapid adoption of generics and biosimilars, while low- and middle-income countries experience increased access due to price reductions and generic availability.

References

[1] IQVIA. (2022). Global HIV Market Data. IQVIA Institute for Human Data Science.

[2] Gilead Sciences. (2022). Annual Report.

[3] Medicines Patent Pool. (2021). HIV Treatment Patent Landscape.

[4] World Health Organization. (2022). HIV/AIDS Global Progress Report.

[5] IQVIA. (2023). Pharmaceutical Market Insights.