COMPLERA Drug Patent Profile

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

Complera is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-three patent family members in fifty-two countries.

The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Complera

Complera was eligible for patent challenges on May 20, 2015.

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for COMPLERA

International Patents:	273
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	6
Drug Prices:	Drug price information for COMPLERA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMPLERA
What excipients (inactive ingredients) are in COMPLERA?	COMPLERA excipients list
DailyMed Link:	COMPLERA at DailyMed

See drug prices for COMPLERA

Recent Clinical Trials for COMPLERA

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

Sponsor	Phase
Gilead Sciences	Phase 3
CIHR Canadian HIV Trials Network	Phase 3
Ottawa Hospital Research Institute	Phase 3

See all COMPLERA clinical trials

Pharmacology for COMPLERA

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

Paragraph IV (Patent) Challenges for COMPLERA

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 COMPLERA

COMPLERA is protected by three US patents.

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	8,841,310		Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	AB	RX	Yes	Yes	7,125,879		Y	Y
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

Expired US Patents for COMPLERA

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	6,642,245*PED
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	5,935,946*PED
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	7,067,522
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	8,080,551

International Patents for COMPLERA

When does loss-of-exclusivity occur for COMPLERA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COMPLERA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2006207874
Indonesia	24701
Denmark	1789139
Norway	20160777	Preparater og fremgangsmåter for antiviral kombinasjonsterapi.
Mexico	2007002594	FUMARATO DE 4-((4-((4- (2-CIANOETENIL)-2, 6-DIMETILFENIL) AMINO)-2-PIRIMIDINIL) AMINO) BENZONITRILO. (FURAMATE OF 4-( (4-( (4- (2-CYANOETHENYL) -2, 6-DIMETHYLPHENYL) AMINO)-2 -PYRIMIDINYL) AMINO)BENZONITRILE.)
Croatia	P20110563

Supplementary Protection Certificates for COMPLERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	CA 2016 00064	Denmark		PRODUCT NAME: KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
0915894	266	Finland
3808743	PA2022515,C3808743	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA FARMACINIU POZIURIU PRIIMTINOS PRIDETINES RILPIVIRINO DRUSKOS, ISKAITANT RILPIVIRINO HIDROCHLORIDO RUGSTIES DRUSKA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1419152	CR 2012 00021	Denmark		PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER HYDROCHLORID ADDITIONSSALTET AF RILPIVIRIN, OG TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
0513200	C00513200/01	Switzerland		PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
1663240	PA2015035,C1663240	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: COMPLERA

Last updated: October 13, 2025

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Introduction

COMPLERA, developed by Gilead Sciences, Inc., is a fixed-dose combination antiretroviral medication used primarily in the management of HIV-1 infection. Comprising four-in-one therapy elements—emtricitabine, rilpivirine, and tenofovir alafenamide—COMPLERA has established itself as a pivotal player within the HIV therapeutic landscape. Understanding the evolving market dynamics and financial trajectory related to COMPLERA necessitates an examination of competitive forces, regulatory trends, patent landscapes, and the broader epidemiology of HIV/AIDS.

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Market Overview

The global HIV therapeutics market has exhibited consistent growth, driven by increasing prevalence, advancements in treatment modalities, and ongoing demand for more tolerable, convenient regimens. In 2022, the global HIV drug market was valued at approximately USD 24 billion, with projections to expand at a compound annual growth rate (CAGR) of 4-6% over the next five years. COMPLERA, as a once-daily, fixed-dose regimen, aligns with the market’s shift towards simplified treatments, catering to adherence and quality-of-life improvements.

Gilead’s portfolio dominance, with COMPLERA accounting for a significant share within its antiretroviral (ARV) offerings, underscores its importance. As of 2023, Gilead’s HIV portfolio remains a key revenue contributor, with COMPLERA, along with other fixed-dose combinations such as BIKTARVY and DESCOVY, forming a substantial part of its strategic positioning.

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Market Dynamics

Competitive Landscape

COMPLERA's main competitors include other fixed-dose combination (FDC) therapies such as BICTEGRAVIR/EMTRICITABINE/Rilpivirine (EDURANT), TRIUMEQ, and generic formulations. The competition is intensifying with the advent of newer agents like long-acting injectables (e.g., Gilead's CABENUVA), which offer alternative dosing schedules and have received regulatory approval globally.

Patent and Exclusivity Trends

Gilead’s patent protection for COMPLERA was initially secured until 2027, with some formulations potentially extending beyond this via pediatric and formulation patents. However, patent expirations are imminent, encouraging generic manufacturers to develop bioequivalent versions, potentially eroding Gilead’s market share unless aggressive lifecycle management strategies, such as formulation improvements or new indications, are employed.

Regulatory Environment

Regulatory agencies such as the FDA and EMA continue to approve new formulations emphasizing safety, tolerability, and convenience. Gilead’s pipeline initiatives targeting drug resistance and long-acting injectables could influence COMPLERA’s market sustainability by offering alternative options that may supersede oral regimens.

Epidemiological Trends

The rising global HIV burden, particularly in regions like sub-Saharan Africa, Asia-Pacific, and Eastern Europe, sustains demand; however, affordability and accessibility challenges influence market penetration. Gilead’s pricing strategies, including tiered pricing and partnerships with global health organizations, aim to mitigate barriers.

Pricing and Reimbursement

Pricing pressures, especially in developed markets with stringent reimbursement policies, impact COMPLERA’s financial performance. The shift towards value-based pricing, emphasizing long-term health outcomes and adherence, influences sales volumes.

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Financial Trajectory

Revenue Generation

Gilead’s HIV franchise has historically generated upwards of USD 8 billion annually, with COMPLERA contributing a significant share. Despite increasing competition, steady adherence, and the drug’s favorable tolerability profile have sustained revenue streams.

Impact of Patent Expiry

Upcoming patent expirations in 2027 and beyond pose significant risks to revenue streams from COMPLERA. The anticipated influx of generic competitors is projected to lead to price erosion, reducing profit margins unless offset by increased volume, new formulations, or expanded indications.

Pipeline and Lifecycle Management

Gilead’s strategized transition towards long-acting formulations aims to compensate for potential declines in oral therapy revenues. The approval of injectable cabotegravir/rilpivirine (CABENUVA) in recent years has positioned the company to capture a significant portion of the evolving market segment favoring less frequent dosing schedules.

Future Growth Prospects

While COMPLERA’s standalone revenues may decline post-patent expiry, Gilead’s broader HIV portfolio and pipeline initiatives are expected to sustain overall revenue growth. Additionally, geographic expansion into emerging markets with rising HIV prevalence offers considerable upside but is contingent upon pricing strategies and local healthcare infrastructure.

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Market Challenges and Opportunities

• Challenges: Patent cliffs, fierce competition from generics and long-acting injectables, price pressures, and supply chain disruptions could hinder revenue growth.
• Opportunities: Expansion into underserved markets, development of next-generation formulations, and leveraging combination therapies to improve adherence and outcomes offer significant upside.

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Conclusion

The financial trajectory of COMPLERA is intricately linked to its patent lifecycle, competitive landscape, and evolving treatment paradigms. While near-term revenues are expected to remain stable thanks to existing market share and regional growth, the impending patent expiries necessitate strategic innovation. Gilead’s investment in long-acting regimens and pipeline expansion positions it well for sustained leadership but requires vigilant market adaptation.

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Key Takeaways

• COMPLERA remains a key asset within Gilead’s HIV portfolio, benefiting from its once-daily fixed-dose regimen.
• Patent expiration around 2027 poses a significant financial risk, with generic competitors likely to erode market share.
• Advances in long-acting injectable therapies present both a challenge and an opportunity, potentially shifting market dynamics.
• Pricing, reimbursement policies, and access in emerging markets critically influence revenue prospects.
• Strategic pipeline investments and diversification are vital to offset revenue decline post-patent expiry.

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FAQs

1. When is COMPLERA’s patent set to expire, and what are the implications?
Gilead’s primary patents for COMPLERA are expected to expire around 2027, opening the market to generic competitors that could significantly reduce the drug’s market share and profitability.

2. How does COMPLERA compare to newer HIV therapies?
While COMPLERA offers the convenience of a fixed-dose, once-daily pill, newer regimens like long-acting injectables (e.g., CABENUVA) are gaining preference due to their reduced dosing frequency, which can improve adherence.

3. What strategies is Gilead pursuing to maintain its market position?
Gilead is focusing on developing long-acting formulations, expanding geographic access, and optimizing its pipeline with innovative therapies to offset revenue erosion from patent expiries.

4. How do global epidemiological trends affect COMPLERA’s market outlook?
Increasing HIV prevalence in certain regions sustains demand, but economic and healthcare infrastructure limitations influence affordability and access, affecting overall sales potential.

5. Are there regulatory risks that could impact COMPLERA’s financial trajectory?
Regulatory considerations include approval of generics post-patent expiration and evolving international guidelines emphasizing newer, potentially superior therapies, which could influence market dynamics.

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References

1. Gilead Sciences. (2022). Annual Report 2022.
2. IQVIA. (2023). Global HIV Market Analysis.
3. U.S. Food and Drug Administration. (2020). Approved HIV Medications.
4. STAT News. (2022). Gilead’s Shift to Long-Acting HIV Therapies.
5. World Health Organization. (2022). HIV/AIDS Fact Sheet.