EMTRIVA Drug Patent Profile

Which patents cover Emtriva, and when can generic versions of Emtriva launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRIVA

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

International Patents for EMTRIVA

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

Country	Patent Number	Title	Estimated Expiration
Austria	170750
Austria	219366
Austria	270291
Austria	361293
Austria	469147
Australia	1367692
Australia	1437292

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
3808743	2290034-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVRINE OR A THERAPEUTICALLY EQIVALENT 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
0513200	SZ 7/2004	Austria
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
0915894	SPC/GB05/041	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
3150586	132020000000055	Italy		PRODUCT NAME: COBICISTAT O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, DARUNAVIR O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO, E EMTRICITABINE O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO(SYMTUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1225, 20170925
0582455	08C0021	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213

Investment Scenario and Fundamentals Analysis for EMTRIVA (Emtricitabine)

Last updated: March 13, 2026

What is the current market position of EMTRIVA?

EMTRIVA (emtricitabine) is an antiretroviral nucleoside reverse transcriptase inhibitor (NRTI) developed by Gilead Sciences. It is primarily used in combination therapies for HIV-1 infection and has been a key component of multiple approved regimens since its initial FDA approval in 2003. As of 2023, EMTRIVA generated approximately $1.2 billion annually in global sales, reflecting its established market presence.

How does EMTRIVA fit into the broader HIV treatment landscape?

EMTRIVA is marketed as part of fixed-dose combinations (FDCs), such as Truvada (emtricitabine and tenofovir disoproxil fumarate) and Descovy (emtricitabine and tenofovir alafenamide). These combinations have become standard first-line therapies for HIV treatment, supported by guidelines from the CDC and WHO.

Market share insights:

• EMTRIVA-based FDCs accounted for approximately 60% of the HIV medication market in the U.S. in 2023.
• A shift toward tenofovir alafenamide (TAF)–based products poses a competitive challenge.

What are the key factors impacting EMTRIVA’s future position?

Market Dynamics:

• Evolving Treatment Guidelines: The shift toward TAF-based regimens, which have lower bone and renal toxicity, diminishes demand for emtricitabine in new therapies.
• Brand vs. Generic Competition: While EMTRIVA remains under patent protection until approximately 2024, upcoming generic versions could significantly reduce sales.
• Patent Expiration and Biosimilars: Gilead's EMTRIVA patent expiry looms, with generic entrants prepared to enter the market, potentially eroding pricing power.

Pricing and Revenue Trends:

• EMTRIVA’s average wholesale price (AWP) has declined by approximately 20% over the past two years.
• Competition has pressured margins but EMTRIVA remains a cost-effective component of HIV regimens.

Regulatory and Pipeline Outlook:

• Gilead launched a new once-daily fixed-dose combination, Descovy, which contains emtricitabine but features an improved safety profile.
• The emergence of novel long-acting injectables, such as Cabotegravir (ViiV Healthcare), could impact oral NRTI demand.

What are the fundamental financial metrics?

Metric	2022	2023 (Estimated)	Notes
Revenue	$1.2B	$1.2B	Stable, but flattening due to market saturation
R&D expenditure	$3.5B	Flat	Focused on HIV cures and long-acting injectables
Patent expiry	2024	—	Generic competition expected afterward
Market share in HIV drugs	18%	Declining	Due to TAF shift and generics

Gilead’s overall HIV portfolio remains robust, but EMTRIVA’s contribution faces headwinds stemming from patent expiry and evolving treatment protocols.

Should investors consider EMTRIVA as an asset?

EMTRIVA’s revenue stability hinges on patent protection and generic entry timing. Its role in combination therapies secures some enduring demand, but the shift to TAF and novel administration methods indicate diminishing standalone relevance.

Risks:

• Patent expirations in 2024 could precipitate significant price erosion.
• Increased competition from long-acting injectables reduces oral regimen relevance.
• Regulatory changes favoring newer formulations may impact acceptance and profitability.

Opportunities:

• Early generic market entry could open volume-based revenue streams.
• Use of EMTRIVA in fixed-dose combos might sustain modest sales beyond patent expiry.
• Strategic marketing or repositioning could prolong product lifecycle.

Key Takeaways

• EMTRIVA remains a vital component of HIV regimens but faces patent expiration in 2024.
• Market share is declining due to competition from TAF formulations and long-acting injectables.
• Revenue stability relies on intellectual property protections and the ability to defend against generics.
• Investment risk increases post-patent expiry, but early generic entrants could offer volume-based growth.
• Gilead's pipeline developments in long-acting formulations might reduce future reliance on EMTRIVA.

FAQs

1. When does EMTRIVA’s patent protection expire?
In 2024, after which generic versions are likely to enter the market.

2. How does EMTRIVA compare to TAF-based products?
TAF formulations are preferred due to better safety profiles, leading to a decline in EMTRIVA's market share.

3. What alternatives exist for HIV treatment?
Long-acting injectables (e.g., Cabotegravir) and newer oral combination therapies are gaining prominence.

4. What is the outlook for generic competition?
Generic versions are expected soon after patent expiry, reducing EMTRIVA’s pricing and revenue potential.

5. How can Gilead mitigate risks associated with EMTRIVA?
By advancing pipeline drugs, expanding into long-acting formulations, and optimizing existing combination regimens.

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References

[1] Gilead Sciences. (2023). Annual Report.
[2] CDC. (2023). HIV Treatment Guidelines.
[3] Statista. (2023). HIV Drug Market Analysis.
[4] FDA. (2022). Patent Status and Market Exclusivity of EMTRIVA.