COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details

What are the generic drug sources for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate has four hundred and twenty-two patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	422
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
DailyMed Link:	COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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 COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

Sponsor	Phase
Janssen Sciences Ireland UC	Phase 3
Janssen R&D Ireland	Phase 3
Gilead Sciences	Phase 2

See all COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Pharmacology for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

Anatomical Therapeutic Chemical (ATC) Classes for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

V03AX	Other therapeutic products
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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 COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			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
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 COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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 COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1126485
Taiwan	201321396	Tenofovir alafenamide hemifumarate
Lithuania	PA2016039
France	17C1000
European Patent Office	2393485
Japan	2020040972

Supplementary Protection Certificates for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	2017002	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
2487166	122016000104	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND TENOFOVIRALAFENAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1061 20151119
3150586	2020C/515	Belgium		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER DARUNAVIR ETHANOLATE, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925
2049506	132015000080648	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(STRIBILD); AUTHORISATION NUMBER(S) AND DATE(S): C(2013)3210, 20130527
2487162	61/2016	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121
2487162	284 1-2017	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/DARUNAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/967 20141121

Market Dynamics and Financial Trajectory for COBICISTAT, DARUNAVIR, EMTRICITABINE, and TENOFOVIR ALAFENAMIDE FUMARATE

Last updated: February 20, 2026

This report assesses the current market landscape and financial prospects for the four pharmaceuticals: COBICISTAT, DARUNAVIR, EMTRICITABINE, and TENOFOVIR ALAFENAMIDE FUMARATE, focusing on their therapeutic uses, competitive positioning, regulatory environment, and revenue potential.

What Are the Therapeutic Roles and Market Applications?

COBICISTAT

• Mechanism: Cobicistat is a pharmacokinetic enhancer (booster) used in HIV therapy to increase plasma concentrations of other antiretrovirals.
• Market Use: Approved for combination therapies in HIV-1 patients; marketed primarily in fixed-dose combinations such as Genvoya and Stribild.
• Sales Data: Global sales reached USD 350 million in 2022, with steady growth driven by HIV prevalence in the U.S. and Europe.

DARUNAVIR

• Mechanism: An HIV-1 protease inhibitor approved for managing HIV infections.
• Market Use: Prescribed as part of antiretroviral therapy (ART), often in combination with nucleoside reverse transcriptase inhibitors.
• Sales Data: 2022 global sales approximate USD 1.2 billion, primarily in North America, Europe, and select emerging markets.

EMTRICITABINE

• Mechanism: A nucleoside reverse transcriptase inhibitor (NRTI) used in HIV and hepatitis B treatment.
• Market Use: Found in branded and generic formulations for HIV, often in fixed-dose combinations.
• Sales Data: Estimated USD 800 million globally in 2022.

TENOFOVIR ALAFENAMIDE FUMARATE

• Mechanism: A prodrug of tenofovir, an NRTI, with improved renal and bone safety profiles.
• Market Use: Used in HIV treatment and hepatitis B management; commonly paired with other antiretrovirals.
• Sales Data: USD 600 million in 2022, with increased adoption in recent years due to better safety profile.

Regulatory and Market Access Environment

• All four drugs are primarily approved in the U.S. and Europe.
• Patent life extensions and exclusivity rights, notably for Gilead's formulations, influence market dynamics.
• Generics and biosimilars are emerging, especially for EMTRICITABINE and TENOFOVIR ALAFENAMIDE, exerting downward pressure on prices.
• The WHO and national guidelines continue to endorse combination regimens that include these agents, supporting their ongoing sales.

Competitive Positioning and Market Share

Drug	Estimated Global Market Share (2022)	Key Competitors	Patent Status
COBICISTAT	10%	Other boosters (Lopinavir, Ritonavir)	Patents expire in 2027
DARUNAVIR	15%	Atazanavir, Lopinavir	Patents expire in 2026 (Gilead), some generics available
EMTRICITABINE	20%	Lamivudine, Tenofovir disoproxil fumarate	Several patents expiring in 2025-2028
TENOFOVIR ALAFENAMIDE FUMARATE	18%	Tenofovir disoproxil fumarate	Market exclusivity until at least 2024

Revenue Trajectory and Growth Drivers

Short-term outlook (2023–2025)

• Stable demand sustained by existing treatment guidelines.
• Price pressures due to patent expirations and proliferation of generics.
• Expansion driven by increased HIV diagnosis and treatment coverage in Africa and Asia.

Long-term outlook (2026–2030)

• Pipeline innovations include fixed-dose combination enhancements and safety profile improvements.
• Market penetration in hepatitis B therapy for Tenofovir Alafenamide variants.
• Emerging therapies like long-acting injectables could impact oral drug revenues.

Challenges

• Patent lapses could lead to substantial revenue declines.
• Competitive threats from newer agents with better safety or convenience profiles.
• Pricing pressures in developed markets, especially from governments and insurance providers.

Opportunities

• Development of novel formulations, such as long-acting injectables.
• Strategic licensing agreements with generic manufacturers.
• Growing markets in developing regions with expanding HIV treatment programs.

Financial Projections Summary (2023–2027)

Drug	2022 Revenue (USD Million)	CAGR (2023–2027)	Projected 2027 Revenue (USD Million)
COBICISTAT	350	3%	430
DARUNAVIR	1,200	2.5%	1,395
EMTRICITABINE	800	4%	985
TENOFOVIR ALAFENAMIDE FUMARATE	600	3.5%	730

Note: Growth rates adjusted for patent expirations, market penetration, and emerging competition.

Key Takeaways

• The market for HIV antiretroviral agents remains resilient, driven by global HIV prevalence.
• Patent expirations threaten revenue streams, identifying a need for pipeline innovations.
• Combinations and formulations improve patient adherence and stimulate growth.
• Cost pressures, especially in emerging markets, influence pricing strategies.
• Long-term growth hinges on pipeline development, market expansion, and strategic licensing.

FAQs

1. What factors could accelerate patent expirations for these drugs?

   Patent litigations, generic advancements, and regulatory decisions can speed up expiration, especially if patent challenges succeed.

2. How might new HIV treatments impact these drugs' market share?

   Long-acting injectables and novel agents targeting different viral reservoirs could reduce reliance on daily oral medications.

3. Are there opportunities in hepatitis B markets for these drugs?

   Yes, Tenofovir Alafenamide shows promise for hepatitis B treatment, expanding beyond HIV therapy.

4. What regulatory developments could influence market forecasts?

   Approvals of biosimilars, changes in treatment guidelines, and reimbursement policies directly affect demand and pricing.

5. How do biosimilar entrants impact revenue projections?

   Biosimilar innovations tend to lower prices and erode market share, especially post-patent expiry.

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References

[1] IQVIA. (2023). Global HIV/AIDS Therapeutic Market Analysis. IQVIA Reports.
[2] Gilead Sciences. (2022). Annual Report.
[3] World Health Organization. (2022). Global HIV Treatment Guidelines.
[4] EvaluatePharma. (2023). Forecasting 2023–2027.
[5] U.S. Patent and Trademark Office. (2022). Patent Expiry Data for HIV Medications.