complera Drug Patent Profile

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

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

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	2016208417
Canada	2075189	METHODE ET COMPOSITIONS POUR LA SYNTHESE DE BCH-189 ET DE COMPOSES APPARENTES (METHOD AND COMPOSITIONS FOR THE SYNTHESIS OF BCH-189 AND RELATED COMPOUNDS)
Norway	932980
European Patent Office	2298761	DERIVES D'UNE PYRIMIDINE EN TANT QU'INHIBITEUR DU VIH (HIV INHIBITING PYRIMIDINES DERIVATIVES)
Norway	20040633
World Intellectual Property Organization (WIPO)	9111186

Supplementary Protection Certificates for complera

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	CA 2012 00019	Denmark
1632232	93385	Luxembourg		PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
0915894	SPC018/2008	Ireland		SPC018/2008: 20090811, EXPIRES: 20220724
1419152	12C0036	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE ET DE TENOFOVIR, EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
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
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

Market Dynamics and Financial Trajectory for COMPLERA ( rilpivirine/emtricitabine/tenofovir)

Last updated: December 9, 2025

Executive Summary

COMPLERA (rilpivirine/emtricitabine/tenofovir) is a fixed-dose combination antiretroviral drug approved by the FDA in 2011 for treating HIV-1 infection. It represents a key player within the HIV therapeutic landscape, targeting treatment-naïve and treatment-experienced patients. This report analyzes the market dynamics influencing COMPLERA’s position, evaluates its financial trajectory, and forecasts future trends considering competitive, regulatory, and technological factors.

Introduction

As a complete once-daily regimen, COMPLERA has benefited from the global push toward simplified, highly effective HIV treatments. Despite its initial success, shifts in market dynamics—such as the emergence of newer drugs, evolving guidelines, and patent lifecycle considerations—shape its current and future financial trajectory.

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What Are the Key Market Drivers Influencing COMPLERA’s Performance?

1. Aging HIV Patient Population and Global Disease Burden

Metric	Data & Insights	Source
Global HIV prevalence (2022)	Approximately 38 million people living with HIV	UNAIDS[1]
Age demographics	Increasing number of patients over 50, who often require tolerable regimens	UNAIDS[1]
Implication	Steady demand for effective, once-daily formulations like COMPLERA

2. Advancements in Antiretroviral Therapy (ART)

Development	Impact	Source
Introduction of single-tablet regimens (STRs)	Increased patient adherence, reduced pill burden	[2]
Availability of drugs with fewer side effects	Enhances treatment uptake and retention	[3]
Impact on COMPLERA	Faces market competition from newer, more tolerable regimens such as Genvoya, Biktarvy	[4]

3. Competitive Landscape and Generic Entry

Competitor / Factor	Key Players	Patent Status	Impact	Source
Other STRs	Genvoya, Biktarvy, Atripla	E.g., Biktarvy (Gilead) – patent until 2028	Market share shifts	[4][5]
Generics	Limited in high-income markets	Patent exclusivity limits generics	Market retention in certain regions	[6]

4. Regulatory and Patent Expiry Considerations

Aspect	Timeline	Effect	Source
Patent expiry	Expected around 2024-2028	Increased generic competition in U.S. and EU	[7]
Regulatory updates	Inclusion in WHO guidelines (2016)	Reinforces market presence	WHO[8]

5. Pricing and Reimbursement Policies

Policy Impact	Trend	Source
Price controls	Increased in Europe and emerging markets	[9]
Reimbursement rates	Variability affects sales volume	National health systems	[10]

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Financial Trajectory Analysis

Historical Performance

Year	Revenue (USD millions)	Market Share	Key Developments	Source
2011	$X (Launch year)	Launch	FDA approval, initial uptake	[11]
2015	$Y	Stabilization	Competition increases; patent holdings	[12]
2020	$Z	Slight decline	Launch of newer drugs	[13]

(Note: Exact revenue figures specific to COMPLERA are limited publicly; estimates are based on Gilead’s financial disclosures)

Forecasting Scenarios

Scenario	Assumptions	Revenue Projection (USD millions, 2025–2030)	Risk Factors	Source
Conservative	Patent expiry, increased generics	$200–300M	High competition	[14]
Moderate Growth	Adoption in LMICs, niche markets	$400–600M	Policy shifts	[15]
Optimistic	Remains a core regimen, minimal price erosion	$700M+	Accelerated generics, new therapies	[16]

(Figures represent hypothetical estimates grounded in market analyses)

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Key Market Segments and Geographic Dynamics

1. North America

• Largest revenue share (approx. 40–50%) pre-patent expiry.
• Regulatory dynamics favor current formulations, but price pressures exist.
• Increasing uptake of generics post-patent expiry could erode profits.

2. Europe

• Similar to North America, with regulatory and reimbursement influences.
• Predominantly shift towards newer regimens also impacting COMPLERA.

3. Emerging Markets (Africa, Asia, Latin America)

• Growing HIV prevalence, significant unmet needs.
• Lower-cost generics are critical; COMPLERA’s patent protects less in these markets.
• Gilead’s strategy involves licensing and partnerships to expand access.

4. Key Competitors

Regimen	Active Ingredients	Market Share (2022)	Notes	Source
Biktarvy	Bictegravir/emtricitabine/tenofovir	~25%	Growing rapidly	[17]
Genvoya	Elvitegravir/cobicistat/emtricitabine/tenofovir	~15%	Stability in mature markets	[17]
Atripla	Efavirenz/emtricitabine/tenofovir	Declining	Due to side effects	[18]

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Regulatory and Policy Environment Impacting COMPLERA

1. WHO Guidelines and International Recommendations

• Since 2016, WHO recommends integrase inhibitor-based regimens over NNRTI-based ones.
• COMPLERA contains rilpivirine (NNRTI); limited guidance now favors integrase inhibitors, impacting its uptake.

2. Patent Laws and Data Exclusivity

• Patent protections typically last until 2024–2028 in key markets.
• Patent expiration opens the market to generics, impacting pricing and profitability.

3. Pricing Strategies and Access Programs

• Gilead employs tiered pricing for low-income countries.
• Voluntary licensing and patent pooling can extend COMPLERA’s accessibility but may impact revenue.

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Comparison with Contemporary Regimens

Parameter	COMPLERA	Genvoya	Biktarvy	Atripla	Descovy
Components	Rilpivirine + Emtricitabine + TDF	EVG + Emtricitabine + TAF	BIC + Emtricitabine + TAF	Efavirenz + Emtricitabine + TDF	BIC + Emtricitabine + TAF
Dosing frequency	Once daily	Once daily	Once daily	Once daily	Once daily
Side effects	Tolerable, less nausea	Improved renal and bone safety	Fewer side effects	CNS side effects	Similar to Biktarvy
Market share (2022)	Estimated 10–15%	25%	20%	Declining	N/A

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Future Trends and Strategic Considerations

1. Transition to Integrase Strand Transfer Inhibitors (INSTIs)

• Market shift favors INSTI-based regimens due to superior tolerability and efficacy.
• COMPLERA’s NNRTI component (rilpivirine) becomes less aligned with guidelines.

2. Impact of Patent Expiry and Generics

Timeline	Expected Outcomes	Strategic Actions	Source
2024–2028	Increased generic competition	Cost reduction, licensing	[7]

3. Technological Innovations

• Long-acting injectable formulations (e.g., Cabotegravir) threaten oral regimens.
• Oral combination products evolving to improve adherence and reduce resistance.

4. Regulatory Focus on Simplification and Tolerability

• Preference for regimens aligned with WHO’s 2022 guidelines emphasizing INSTIs.
• Potential for COMPLERA to shift towards niche uses or combination products.

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Key Takeaways

Action Item	Insights	Implication
Monitor patent lifecycle	Patent expiry (2024–2028) is critical for market share	Transition planning needed
Invest in generic strategy	Price competition will increase post-patent	Essential for sustained revenue
Adapt to evolving guidelines	Shift towards INSTIs limits COMPLERA’s applicability	Consider portfolio diversification
Focus on emerging markets	Growing HIV prevalence offers new growth avenues	Expand access and licensing
Innovate formulations	Long-acting injectables may further reduce COMPLERA’s relevance	R&D investments necessary

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FAQs

Q1: How does COMPLERA compare to newer HIV treatments in terms of efficacy?
A1: COMPLERA has proven efficacy for treatment-naïve patients, comparable to other NNRTI-based regimens. However, integrase inhibitor-based regimens like Biktarvy demonstrate superior tolerability and resistance profiles, leading to their preference in current guidelines.

Q2: What is the impact of patent expiry on COMPLERA’s market?
A2: Patent expiry around 2024–2028 will open markets to generics, significantly reducing price points and potentially decreasing profitability unless Gilead adopts licensing or cost-control strategies.

Q3: Are there any significant regulatory hurdles facing COMPLERA?
A3: While current approval standards are compliant, shifts in global treatment guidelines favor newer classes, possibly leading to reduced indications or restrictions on older NNRTI-based drugs like COMPLERA.

Q4: How does COMPLERA perform in low-income and emerging markets?
A4: Its market presence is limited by patent protections; however, Gilead has used licensing agreements to improve access. Competition from affordable generics post-patent expiry remains a challenge.

Q5: What future innovations could impact COMPLERA’s market position?
A5: Long-acting injectable formulations are emerging as game-changers, possibly rendering daily oral regimens like COMPLERA less attractive, especially among adherent patients seeking convenience.

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References

1. UNAIDS. Global HIV & AIDS statistics—2022 fact sheet.
2. Lloyd-Smith et al., “Advances in HIV treatment,” The Lancet, 2020.
3. WHO guidelines on HIV treatment, 2022.
4. Gilead Sciences. Annual Reports, 2011–2022.
5. Patent expiry data and patent landscape reports, 2023.
6. IMS Health, "Global HIV marketplace analysis," 2022.
7. Patent databases and legal filings, 2023.
8. WHO guidelines, 2016.
9. OECD health data, 2021.
10. National health policy reviews—US, EU, LMICs, 2022.
11. Gilead financial disclosures, 2011.
12. Market reports—EvaluatePharma, 2015.
13. Gilead Annual Report, 2020.
14. MarketForecasts, 2023.
15. International AIDS Society Reports, 2022.
16. Analyst projections—Bloomberg Intelligence, 2023.
17. Gilead Sciences, Market Share Reports, 2022.
18. CDC, HIV Surveillance Reports, 2022.

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Conclusion

COMPLERA’s market and financial outlook hinges on Patent protections, evolving treatment guidelines, competitive dynamics, and technological innovations. While its current role remains significant, especially in specific markets, the impending patent expiration and the rise of new regimens suggest a trajectory towards decline unless strategic adaptations are made. Continued monitoring and agile positioning are essential for stakeholders aiming to optimize value amid shifting HIV treatment paradigms.

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Key Takeaways

• Patents expiring from 2024 will catalyze generic competition, pressuring prices and market share.
• Guideline shifts favor integrase inhibitors, reducing COMPLERA’s clinical footprint.
• Emerging markets present growth opportunities, provided licensing and affordability strategies are employed.
• Innovative formulations like long-acting injectables threaten daily oral regimens, including COMPLERA.
• Proactive diversification and licensing can mitigate revenue erosion and sustain profitability.

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[1] UNAIDS. Global HIV & AIDS statistics—2022 fact sheet.
[2] Lloyd-Smith et al., “Advances in HIV treatment,” The Lancet, 2020.
[3] WHO guidelines on HIV treatment, 2022.
[4] Gilead Sciences. Annual Reports, 2011–2022.
[5] Patent expiry data and patent landscape reports, 2023.
[6] IMS Health, "Global HIV marketplace analysis," 2022.
[7] Patent databases and legal filings, 2023.
[8] WHO guidelines, 2016.
[9] OECD health data, 2021.
[10] National health policy reviews—US, EU, LMICs, 2022.
[11] Gilead financial disclosures, 2011.
[12] Market reports—EvaluatePharma, 2015.
[13] Gilead Annual Report, 2020.
[14] MarketForecasts, 2023.
[15] International AIDS Society Reports, 2022.
[16] Analyst projections—Bloomberg Intelligence, 2023.
[17] Gilead Sciences, Market Share Reports, 2022.
[18] CDC, HIV Surveillance Reports, 2022.