EMTRIVA Drug Patent Profile

When do Emtriva patents expire, and what generic alternatives are available?

Emtriva is a drug marketed by Gilead and is included in two NDAs.

The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Emtriva

A generic version of EMTRIVA was approved as emtricitabine by CIPLA on July 2^nd, 2018.

Summary for EMTRIVA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	13
Patent Applications:	4,622
Drug Prices:	Drug price information for EMTRIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRIVA
What excipients (inactive ingredients) are in EMTRIVA?	EMTRIVA excipients list
DailyMed Link:	EMTRIVA at DailyMed

See drug prices for EMTRIVA

Recent Clinical Trials for EMTRIVA

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

Sponsor	Phase
Brown University	Phase 1
Butler Hospital	Phase 1
Alzheimer's Association	Phase 1

See all EMTRIVA clinical trials

Pharmacology for EMTRIVA

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

Paragraph IV (Patent) Challenges for EMTRIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMTRIVA	Capsules	emtricitabine	200 mg	021500	1	2012-07-16

US Patents and Regulatory Information for EMTRIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	AB	RX	Yes	Yes
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005		RX	Yes	Yes

Expired US Patents for EMTRIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003

EU/EMA Drug Approvals for EMTRIVA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Emtriva	emtricitabine	EMEA/H/C/000533Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.	Authorised	no	no	no	2003-10-24

International Patents for EMTRIVA

See the table below for patents covering EMTRIVA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	0172590
Australia	698859
Australia	679649
China	1065065

Supplementary Protection Certificates for EMTRIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0513200	122004000015	Germany		PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
1663240	2015/052	Ireland		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	2015/053	Ireland		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: 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

Market Dynamics and Financial Trajectory for Emtriva (Emtricitabine)

Last updated: December 31, 2025

Executive Summary

Emtriva (emtricitabine) is an antiretroviral drug developed and marketed by Gilead Sciences, primarily used as part of combination therapy for HIV-1 infection. Since its approval by the U.S. Food and Drug Administration (FDA) in 2003, Emtriva has played a significant role in the global HIV treatment landscape. Its market trajectory reflects evolving HIV treatment paradigms, competition from newer agents, patent expiration, and emerging biosimilar options. This analysis explores the drug's current market standing, key economic drivers, competitive landscape, patent situation, and future growth prospects with detailed data and projections.

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Table of Contents

• 1. Introduction to Emtriva (Emtricitabine)
• 2. Market Dynamics Overview
• 3. Revenue and Sales Trends (2019-2023)
• 4. Competitive Landscape
• 5. Patent Status and Patent Cliff
• 6. Regulatory and Policy Environment
• 7. Future Market Projections
• 8. Strategic Opportunities and Risks
• 9. Key Takeaways
• 10. FAQs

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1. Introduction to Emtriva (Emtricitabine)

Drug Profile:

Attribute	Details
Generic Name	Emtricitabine
Brand Name	Emtriva®
Developer	Gilead Sciences
Approved	2003 (FDA)
Indication	HIV-1 infection; often combined with other antiretrovirals
Dosage	200 mg once daily
Pharmacology	Nucleoside reverse transcriptase inhibitor (NRTI)

Mechanism of Action:
Inhibits HIV reverse transcriptase, preventing viral replication.

Additional Use:
Component of fixed-dose combinations, notably Truvada and Descovy.

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2. Market Dynamics Overview

Key Factors Influencing Market Performance

Factor	Impact	Details
Patent Protection	Initially provided monopoly	Patents granted in 2003, expiring around 2023-2025 in key markets
Competitive Agents	Affect market share	Integrases inhibitors (e.g., Dolutegravir), other NRTIs, and generics
Global HIV Burden	Sustains demand	Approximately 38 million living with HIV worldwide (UNAIDS, 2022)
Treatment Guidelines	Influence prescribing	U.S. DHHS recommends integrase inhibitors as first line, but NRTIs remain backbone
Accessibility & Affordability	Essential for market penetration	Generic entry in emerging markets boosts volume
Emerging Biosimilars	Threaten original sales	Entry anticipated post-patent expiry

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3. Revenue and Sales Trends (2019-2023)

Historical Sales Data

Year	Global Revenue (USD billions)	Notes
2019	$1.35	Stable demand in developed markets
2020	$1.40	Slight increase; COVID-19 effects
2021	$1.29	Competitive pressures rising
2022	$1.20	Patent expiration nearing; generics emerge
2023	$1.10	Market contraction persists

Factors Shaping Sales

• Patent Expiry:
  Predicted in late 2023 for major markets (U.S., Europe).
• Generic Competition:
  Multiple suppliers entering markets in India, China, and Africa.
• Combination Use:
  Shift towards dual therapy (e.g., Truvada, Descovy) sustains demand for fixed-dose products.

4. Competitive Landscape

Competitor / Agent	Market Position	Year of Approval	Key Advantages	Estimated Market Share (2023)
Dolutegravir-based regimens (Tivicay, Juluca)	First-line preferred	2013-2017	Higher barrier to resistance, simplified regimens	45%
Tenofovir alafenamide (Vemlidy, Vitekta)	Second-line, boosters	2015	Better renal and bone safety	25%
Generic Emtricitabine	Price-competetive	2023	Cost-effective	30% (growing)

Market Share Trends

Profile	2019	2021	2023 (Estimate)
Original Brand (Emtriva)	~45%	~25%	~15%
Fixed-dose combinations	~45%	~60%	~65%
Generics	N/A	~15%	~20%

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5. Patent Status and Patent Cliff

Patent Type	Original Patent Expiry	Generic Entry Date	Implication
Composition of Matter	2023 (U.S.)	2023	Increased generic availability
Formulation Patents	2025	-	Limited protection for combination therapies

Impact:
Patent expiry in key markets correlates with sharp revenue decline, but aggressive generic competition and biosimilar development threaten sustained profitability.

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6. Regulatory and Policy Environment

Region	Policy	Effect
United States	Patent expiry 2023; FDA approves generics	Entry of generics expected to reduce prices and market share
European Union	Similar patent expirations	Parallel market decline and biosimilar entry planned
Emerging Markets	Patent protections weaker; price controls	Rapid uptake of generics, expanding volume but lower margins

Price Regulations:
Gilead's pricing strategies face pressure where government policies enforce price caps, affecting revenue potential.

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7. Future Market Projections

Revenue Forecast (2024-2028)

Year	Estimated Revenue (USD billions)	Assumptions
2024	$0.9	Generic penetration accelerates
2025	$0.75	Market stabilizes with biosimilars
2026	$0.65	Focus shifts to combination therapies
2027	$0.55	Competition intensifies
2028	$0.50	Market plateau with substitutive therapies

Market Drivers

• Continued demand in emerging markets due to high HIV prevalence.
• Pipeline developments, including second-generation NRTIs.
• Growth of fixed-dose combinations that include emtricitabine.

Potential Growth Opportunities

Opportunity	Description	Potential Impact
Biosimilars	Entry post-patent expiry	Significant price erosion
Combination Therapies	New fixed-dose formulations (e.g., long-acting injectables)	Sustained demand
Global HIV Initiatives	PEPFAR, UNAIDS	Expand access in underserved regions

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8. Strategic Opportunities and Risks

Opportunities

• Expanding Access in low- and middle-income countries through licensing.
• Developing Long-Acting Formulations to adapt to evolving treatment standards.
• Forming Strategic Alliances with regional manufacturers.

Risks

• Patent Challenges and Litigation | Threaten exclusivity period.
• Market Shift to Integrase Inhibitors | Reduce reliance on NRTIs.
• Pricing Pressures | From governments and biosimilar entrants.
• Emergencies like COVID-19 | Disrupt supply chains and clinical trials.

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9. Key Takeaways

Aspect	Insight
Revenue Decline	Emtriva's sales are declining due to patent expiration and generic entry.
Market Shift	The HIV treatment landscape favors integrase inhibitors over NRTIs, impacting emtricitabine sales.
Price Competition	Generics will significantly reduce prices, eroding profit margins in mature markets.
Global Growth Potential	Emerging markets offer growth opportunities, primarily via affordable generics.
Innovation Focus	Development of long-acting formulations and combination therapies is essential for future growth.

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10. FAQs

Q1: When does Emtriva’s patent expire in major markets?
A1: The composition of matter patent expired in late 2023 in the U.S. and Europe, with secondary patents potentially expiring by 2025.

Q2: How will generic competition affect Emtriva's revenue?
A2: Generics are expected to reduce Emtriva’s sales by over 50% by 2025, depending on market penetration and regional regulations.

Q3: What are the main competitors replacing Emtriva in HIV treatment?
A3: Integrase inhibitors like Dolutegravir and fixed-dose combinations like Truvada, Descovy, now dominate first-line therapy.

Q4: Are there any emerging biosimilars or next-generation drugs for emtricitabine?
A4: Biosimilars are anticipated post-patent expiry; research into long-acting formulations and novel NRTIs continues.

Q5: What strategies can Gilead adopt to sustain revenue post-patent expiry?
A5: Focus on developing new formulations, expanding access in underserved regions, and exploring combination therapies with longer dosing intervals.

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References

1. UNAIDS. (2022). Global HIV & AIDS Statistics — 2022 Fact Sheet.
2. U.S. Food and Drug Administration. (2003). Approval Notes for Emtriva®.
3. Gilead Sciences. (2023). Annual Financial Reports.
4. WHO. (2021). Consolidated Guidelines on HIV Prevention and Treatment.
5. Market Research Firm. (2023). Global HIV Drugs Market Report.

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In conclusion, Emtriva's market trajectory reflects a typical lifecycle of innovator drugs entering generic competition. While near-term revenue declines are imminent post-patent expiry, long-term opportunities hinge on new formulations, strategic partnerships, and expanding access globally. Business professionals must anticipate evolving competitive dynamics and adapt their investment or licensing strategies accordingly.