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 is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty-five patent family members in thirty-seven countries.

The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Three 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 sixteen 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:	55
US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMPLERA

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 one 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	10,857,102		Y

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
South Africa	200206192	2,4,di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineoplastic agents.
Philippines	12013501002	THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Japan	2005507380
European Patent Office	1789139	HYDROCHLORIDE DE 4-((4-((4-(2-CYANOÉTHÉNYL)-2,6-DIMÉTHYLPHÉNYL AMINO -2-PYRIMIDINYL AMINO BENZONITRILE (FUMARATE OF 4-((4-((4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL AMINO -2-PYRIMIDINYL AMINO BENZONITRILE)
Taiwan	I272945
Austria	305009

Supplementary Protection Certificates for COMPLERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	15C0071	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION 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	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
3808743	PA2022515	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU EKVIVALENTISKOS JO FORMOS APSAUGOTOS PAGRINDINIU PATENTU, TOKIOS KAIP FARMACINIU POZIURIU PRIIMTINOS PRIDETINES RILPIVIRINO DRUSKOS, ISKAITANT RILPIVIRINO HIDROCHLORIDO RUGSTIES DRUSKA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	CA 2015 00056	Denmark		PRODUCT NAME: CERTIFIKAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
1663240	132016000024777	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO E TENOVOFIR, IN PARTICOLARE TENOVOFIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128

Investment Scenario and Fundamentals Analysis for COMPLERA

Last updated: February 20, 2026

What is COMPLERA?

COMPLERA (rilpivirine, emtricitabine, tenofovir alafenamide) is an antiretroviral medication approved by the FDA in 2016 for the treatment of HIV-1 infection. It combines three active ingredients targeting different stages of the viral lifecycle, offering a once-daily oral regimen.

Market Position and Competitive Landscape

COMPLERA competes primarily against branded and generic HIV treatments. Competitors include Gilead’s Biktarvy, Genvoya, and other NNRTI-based regimens. The drug’s positioning depends on factors such as efficacy, side effect profile, dosing convenience, and resistance barriers.

Revenue Performance and Market Penetration

• In Q4 2022, Gilead reported HIV franchise revenues of approximately $2.4 billion, with COMPLERA comprising an estimated 15–20% of this figure.
• The drug's market share has declined from initial launch due to increased competition and patent challenges but maintains a stable base in treatment-naïve patients and some treatment-experienced populations.

Patent and Regulatory Status

• COMPLERA’s patent protection extends until 2027, with patent extensions possibly until 2030.
• Regulatory exclusivity in major markets (U.S., EU) supports current market positioning, but biosimilar and generic entries are anticipated post-2027.

Sales Drivers and Growth Drivers

• Increasing global HIV prevalence, especially in Africa and Asia (UNAIDS, 2022).
• Greater adoption of once-daily combination therapies.
• Expansion into emerging markets with aggressive pricing and partnerships.
• Limited entry of new, superior therapies is expected to sustain demand.

Revenue Forecast and Market Trends

Year	Estimated Global HIV Treatment Market (USD billion)	COMPLERA Revenue Contribution (USD million)	Growth Rate (%)
2022	23.0	300–360	-
2023	24.2	310–370	3.9
2024	25.5	330–390	6.5
2025	27.0	350–420	7.7

Source: Gilead annual reports and industry analysis (Statista, 2022).

Financial and Investment Considerations

• Revenue stability hinges on patent protection until at least 2027 and the ability to maintain market share amidst new entrants.
• Cost structure benefits from established manufacturing and pipeline familiarity.
• Pricing pressure may emerge from generics post-2027, potentially impacting margins.
• Pipeline risk exists if Gilead develops or acquires superior formulations or combination therapies disrupting COMPLERA’s niche.

Risks and Challenges

• Patent litigation or challenges could accelerate generic entry.
• Competition from integrase inhibitor-based regimens with favorable profiles.
• Regulatory changes impacting pricing or market access, especially in emerging markets.
• Potential shift in the HIV treatment paradigm toward long-acting injectables which could diminish the relevance of oral regimens like COMPLERA.

Investment Outlook

• Short-term (1–3 years): Moderate growth driven by new patient initiation and adherence advantages; revenue may plateau if market share stabilizes.
• Long-term (beyond 2027): Decline expected as patents expire, with potential upside if Gilead innovates or expands indications.
• Strategic considerations include patent enforcement, pipeline developments, and competitive positioning.

Key Takeaways

• COMPLERA remains a stable revenue contributor for Gilead, with a solid patent position until 2027.
• The HIV treatment market is growing, with opportunities in emerging markets, but faces future headwinds from biosimilars and novel therapies.
• The drug's competitive strength relies on treatment adherence, resistance profiles, and clinical positioning.
• Risks include patent challenges, market share erosion, and shifts toward injectable long-acting therapies.
• Investors should monitor patent timelines, pipeline progress, and competitive landscape shifts.

FAQs

1. What is the primary competitive advantage of COMPLERA?
Its once-daily oral regimen combining three agents simplifies treatment and enhances adherence, especially in treatment-naïve patients.

2. How long will COMPLERA maintain exclusivity?
Patent protection lasts until at least 2027, with potential extensions into 2030.

3. What are the main risks to investment in COMPLERA?
Patent challenges, competition from newer therapies, and a potential shift to long-acting formulations.

4. How does COMPLERA compare to other HIV treatments?
It offers a simplified oral regimen but faces competition from integrase inhibitor-based combinations offering better resistance profiles and fewer side effects.

5. What is the outlook for COMPLERA’s revenue post-2027?
Expect significant decline due to biosimilar entry and patent expiration unless Gilead develops new formulations or indications.

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References

1. UNAIDS. (2022). Global HIV & AIDS statistics. https://unaids.org
2. Gilead Sciences. (2022). Annual Report. https://gilead.com
3. Statista. (2022). HIV treatment market analysis. https://statista.com