SYMTUZA Drug Patent Profile

When do Symtuza patents expire, and when can generic versions of Symtuza launch?

Symtuza is a drug marketed by Janssen Prods and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and ninety-six patent family members in fifty-two countries.

The generic ingredient in SYMTUZA is cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Symtuza

Symtuza was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 6, 2032. This may change due to patent challenges or generic licensing.

There have been twenty-seven 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 SYMTUZA

International Patents:	496
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Drug Prices:	Drug price information for SYMTUZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMTUZA
What excipients (inactive ingredients) are in SYMTUZA?	SYMTUZA excipients list
DailyMed Link:	SYMTUZA at DailyMed

See drug prices for SYMTUZA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SYMTUZA

NDA:

210455

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SYMTUZA

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

Sponsor	Phase
East Carolina University	Phase 4
Imperial College London	Phase 3
Chelsea and Westminster NHS Foundation Trust	Phase 3

See all SYMTUZA clinical trials

Pharmacology for SYMTUZA

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor Protease Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for SYMTUZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMTUZA	Tablets	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	800 mg/150 mg/ 200 mg/10 mg	210455	1	2021-08-16

US Patents and Regulatory Information for SYMTUZA

SYMTUZA is protected by fourteen US patents.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y

Expired US Patents for SYMTUZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018

International Patents for SYMTUZA

When does loss-of-exclusivity occur for SYMTUZA?

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

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Peru

Poland

Portugal

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 SYMTUZA around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	3150586
Bulgaria	66037
Croatia	P20161502
Serbia	55280
Norway	20030270
South Korea	20140054068

Supplementary Protection Certificates for SYMTUZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	11/2016	Austria		PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061/001-002 (MITTEILUNG) 20151123
2487163	2016C/066	Belgium		PRODUCT NAME: COBICISTAT ET ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 20150715
0513200	C00513200/01	Switzerland		PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
2487166	300860	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2487163	1790002-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1025, 2015-07-15
3150586	122020000022	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND EMTRICITABIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170921

Market Dynamics and Financial Trajectory for SYMTUZA: A Comprehensive Analysis

Last updated: November 17, 2025

Introduction

SYMTUZA (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) is a once-daily, fixed-dose combination antiretroviral therapy (ART) approved for the treatment of HIV-1 infection. Since its launch, SYMTUZA has gained significant attention within the global HIV treatment landscape, driven by its efficacy, convenience, and growing demand for comprehensive HIV regimens. Understanding the evolving market dynamics and analyzing its financial trajectory are crucial for stakeholders—including pharmaceutical companies, investors, healthcare providers, and policymakers—aiming to navigate this competitive landscape effectively.

This report offers an in-depth analysis of SYMTUZA's market evolution, key drivers and challenges, revenue projections, competitive positioning, and strategic considerations influencing its financial performance.

---

Market Overview and Dynamics

Global HIV Treatment Landscape

The global HIV treatment market has experienced robust growth, driven by increasing access to antiretroviral therapy (ART), improved healthcare infrastructure, and expanded awareness campaigns. According to UNAIDS, approximately 38 million individuals worldwide live with HIV, with significant treatment gaps, particularly in low- and middle-income countries (LMICs) [1].

The shift toward fixed-dose combinations (FDCs) like SYMTUZA reflects a broader trend in HIV management—reducing pill burden, improving adherence, and enhancing long-term outcomes. The FDC approach simplifies regimens, mitigates the risk of resistance, and aligns with patient-centric care models ("Once-Daily Fixed-Dose Combinations for HIV"—WHO, 2022).

Competitive Landscape

Market players include Gilead Sciences, ViiV Healthcare, Janssen Pharmaceuticals, and several generics manufacturers. SYMTUZA’s key competitors comprise similar HIV FDCs such as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), Triumeq, and Delstrigo, each vying for market share based on efficacy, safety profiles, pricing, and formulation convenience.

Gilead’s Biktarvy currently dominates, owing to its strong efficacy and widespread adoption. However, SYMTUZA leverages its distinct combination of agents and potential advantages in specific patient populations, positioning it as a competitive alternative.

Market Drivers

• Efficacy and Safety Profile: Clinical trials have underscored SYMTUZA’s comparable efficacy and tolerability, fostering clinician confidence.
• Dosing Convenience: The once-daily FDC enhances adherence, crucial in achieving viremia suppression.
• Expanding Treatment Guidelines: WHO and various national guidelines increasingly recommend all-in-one regimens, including SYMTUZA, broadening its adoption.
• Growing HIV Prevalence: Persistent increases in diagnosed cases sustain long-term demand for effective ART options.
• Market Expansion in LMICs: Initiatives to improve access drive revenues as generic versions and licensing agreements facilitate broader availability.

Market Challenges

• Intense Competition: Dominance of established brands like Biktarvy limits potential growth.
• Pricing Pressures: Push toward lower-cost generics constrains margins, especially in LMICs.
• Patent Landscapes: Patent protections and licensing agreements influence market entry and generic competition.
• Side Effect Profiles and Safety: Concerns over tenofovir alafenamide’s renal and bone safety in certain patient groups may impact prescribing behaviors.

---

Financial Trajectory Analysis

Revenue Generation and Market Penetration

Since its launch, SYMTUZA's revenue trajectory has been characterized by initial modest uptake, followed by gradual growth facilitated by expanding indications and therapeutic positioning.

• Initial Stage (2020-2021): Launch in key markets such as the US and Europe garnered moderate revenues, primarily from high-income segments with established treatment protocols.

• Growth Phase (2022-2024): Adoption accelerated as clinical guidelines endorsed the regimen, with increased prescriptions in both hospital and outpatient settings. Strategic collaborations with governments and NGOs in LMICs bolstered distribution and revenue inflows.

• Projected Expansion (2025 and beyond): Market analysts forecast sustained growth, driven by cumulative patient adoption, new indications, and geographic expansion.

Revenue Projections and Market Share

Sources estimate that SYMTUZA could capture a significant portion of the HIV FDC market, which was valued at approximately $9 billion globally in 2022 [2]. Assuming a conservative market share of 10-15% of the FDC segment, revenues could reach $1-1.35 billion within five years.

Key factors influencing revenue include:

• Pricing Strategies: Tiered pricing tailored to income levels to maximize access and margins.
• Patent Expiry and Generics: Patent expiration dates around 2025 could introduce generic competition, impacting pricing and revenues.
• Geographic Expansion: Entry into LMIC markets via licensing and subsidies will expand volume, though at lower price points.

Profitability and Cost Dynamics

Profit margins hinge on manufacturing efficiencies, R&D investments, clinical trial costs, and marketing. The high-cost environment of HIV drug development necessitates sustained sales volume to ensure profitability. Licensing deals and partnerships can mitigate R&D costs and accelerate revenue streams.

Regulatory and Reimbursement Trends

Regulatory approvals in emerging markets will unlock revenue potential, contingent upon licensing agreements and local pricing policies. Reimbursement approval by national health systems remains critical; favorable reimbursement decisions directly impact adoption rates.

---

Strategic Positioning and Market Opportunities

Differentiation and Value Proposition

SYMTUZA’s differentiators include its comprehensive antiviral activity, tolerability, and convenience. Emphasizing these attributes in marketing campaigns enhances prescriber uptake.

Partnering and Licensing Strategies

Expanding licensing agreements in LMICs will facilitate market penetration, especially where patent constraints or affordability issues exist. Collaborations with public health authorities can drive large-scale implementation.

Pipeline and Future Indications

Ongoing clinical trials investigating SYMTUZA's utility in pre-exposure prophylaxis (PrEP) and as part of HIV cure strategies could diversify revenue streams, provided evidence supports new indications.

---

Impacts of Patent Expiry and Market Entry of Generics

Patent protections for SYMTUZA are expected to last until 2025, after which generic versions could impact revenues significantly. Low-cost generics may erode market share in lower-income countries but could also open avenues for widespread use, particularly when bundled with national AIDS programs.

Potential Market Disruption

If well-executed, generic entry could prompt price reductions of up to 70-80%, pressuring margins for branded versions. However, brand manufacturers might counter by emphasizing value-added services, formulations, or combination innovations.

---

Key Takeaways

• Growth prospects remain positive, driven by expanding access, evolving treatment guidelines, and a growing global HIV population.
• Intense competition from established brands and imminent generic entries will shape pricing dynamics and market share.
• Strategic licensing and expansion into LMICs are paramount for sustaining revenue growth.
• Regulatory developments and reimbursement policies significantly influence financial trajectories.
• Pipeline developments and potential new indications could provide supplementary revenue sources, bolstering long-term viability.

---

Conclusion

SYMTUZA’s market and financial outlook typify a mature yet still expanding segment within HIV therapeutics. While competitive pressures and patent timelines present hurdles, strategic positioning, global access initiatives, and ongoing clinical development bolster its potential. Stakeholders must continually adapt to shifting regulatory landscapes, pricing pressures, and therapeutic innovations to optimize SYMTUZA’s market impact and financial performance.

---

FAQs

1. When is SYMTUZA expected to face generic competition, and what are its implications?
Patent expiration around 2025 may lead to generic entrants, reducing prices and market share. Manufacturers can mitigate this by expanding into indications such as PrEP and enhancing patient adherence strategies.

2. How does SYMTUZA compare to competitors like Biktarvy in efficacy and safety?
Clinical studies demonstrate comparable efficacy. SYMTUZA’s safety profile aligns with its components but requires monitoring for renal and bone health in some patients.

3. What strategies can maximize SYMTUZA’s revenue in emerging markets?
Leveraging licensing agreements, tiered pricing, and collaboration with health authorities to foster broad access are key strategies.

4. What role do treatment guidelines play in SYMTUZA’s market penetration?
Alignment with WHO and national guidelines endorsing FDCs influences clinician prescribing patterns, directly impacting sales.

5. What are the prospects for SYMTUZA in HIV pre-exposure prophylaxis (PrEP)?
Current evidence is limited; ongoing trials may expand its use if safety and efficacy profiles support prophylactic applications.

---

References

[1] UNAIDS. Global HIV & AIDS Statistics — Fact Sheet. 2022.
[2] Market Research Future. HIV Therapeutics Market Analysis. 2022.