cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate - Profile

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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.

Summary for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

International Patents:	425
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

Constraining patent/regulatory exclusivity:

7,700,645

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.

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	8,754,065		Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	9,296,769		Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	8,148,374		Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	10,786,518
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	10,039,718		Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	7,700,645		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	8,597,876
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	6,642,245
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	7,470,506
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	8,518,987
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	7,390,791
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	9,889,115
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	6,703,396

International Patents for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3089
African Regional IP Organization (ARIPO)	3250
Argentina	075369
Australia	2009242451
Australia	2010210598
Australia	2014221210
Australia	2015200637

Supplementary Protection Certificates for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	201540054	Slovenia		PRODUCT NAME: COBICISTAT OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001-002; DATE OF NATIONAL AUTHORISATION: 20130524; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2487163	2016/062	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTRATION NO/DATE: EU/1/15/1025 20160713
2487162	PA2016040,C2487162	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS IR DARUNAVIRAS,ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
3150586	LUC00156	Luxembourg		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925
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
3150586	301045	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER DARUNAVIRETHANOLAAT, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1225 20170925
2049506	2015C/058	Belgium		PRODUCT NAME: COBICISTAT AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001 20130527

Investment Landscape and Market Dynamics for Cobicistat, Darunavir, Emtricitabine, and Tenofovir Alafenamide Fumarate

Last updated: February 3, 2026

Summary

This report analyzes the investment potential, market dynamics, and financial trajectories of four key antiretroviral drugs: cobicistat, darunavir, emtricitabine, and tenofovir alafenamide fumarate (TAF). These compounds are essential in HIV therapy, with expanding indications and increasing global demand. The assessment combines market size estimates, pipeline developments, regulatory pathways, patent landscapes, and competitive positioning to aid investors, pharmaceutical companies, and stakeholders.

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What Are the Investment Opportunities for These HIV Drugs?

Drug	Current Indications	Market Size (2022)	Key Drivers	Challenges	Revenue Potential (2022-2027)
Cobicistat	Pharmacokinetic booster for antiretroviral regimens	$1.2B	Increasing use in fixed-dose combinations (FDCs)	Patent expiries, generic entry	CAGR ~3-5%
Darunavir	HIV-1 protease inhibitor	$2.5B	Growing HIV prevalence, fixed-dose regimens	Resistance development, generics	Conservative CAGR ~2-4%
Emtricitabine	NRTI component in ART	$3.8B	Ubiquity in HIV regimens, long market presence	Patent cliff, biosimilars	Steady growth at 2-3%
Tenofovir Alafenamide (TAF)	Tenofovir prodrug for HIV, HBV	$5.2B	Shift from TDF to TAF for safety profile	Patent protections, new formulations	Rapid growth, CAGR ~8-12%

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What Are the Market Dynamics Shaping These Drugs?

Global HIV Epidemiology and Treatment Trends

• Increasing Global HIV Prevalence: ~38 million (UNAIDS, 2022), particularly in sub-Saharan Africa, Asia, and Eastern Europe.
• Treatment Guidelines: Emphasis on combination regimens minimizing side effects, with TAF replacing TDF in many settings.
• Market Expansion: WHO's pivot on universal access and newer formulations drives demand.

Regulatory Environment

• Regulatory Approvals: Continued approvals for fixed-dose combination (FDC) products, including TAF-based regimens.
• Patent Expirations: Several key patents expired or are nearing expiry, inducing competition, but new formulations and second-generation drugs are mitigating price erosion.

Pipeline and Innovation

Development Stage	Drugs/Combinations	Implications
Approved/Marketed	Cobicistat, Darunavir, Emtricitabine, TAF	Mature markets, ongoing competition
Phase III/II	Next-gen formulations, fixed-dose combinations	Potential revenue increase, market expansion

Competitive Landscape

Major Players	Focus Areas	Market Share (2022)	Key Strategies
Gilead Sciences	Emtricitabine, TAF	~45%	Portfolio expansion, patent protection
ViiV Healthcare	Darunavir, Cobicistat	~25%	Specialty focus, new formulations
Johnson & Johnson	Darunavir, Cobicistat	~10%	Broad HIV portfolio, innovation
Others	Generics, biosimilars	Remaining	Price competition

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Financial Trajectory and Revenue Projections

Revenue Forecasts (2022–2027)

Drug	2022 Revenue (USD Millions)	Projected CAGR (2022–2027)	2027 Revenue (USD Millions)
Cobicistat	1,200	3-5%	1,420–1,400
Darunavir	2,500	2-4%	2,610–2,720
Emtricitabine	3,800	2-3%	4,050–4,620
TAF (all formulations)	5,200	8-12%	8,870–11,560

Factors Influencing Revenue Trajectories

• Patent Lifespans: Key patents extending to 2024–2028 for various formulations.
• Generic Competition: Pressure on prices, especially post-patent expiry.
• New Formulations: Once-daily, multi-drug FDCs expand markets.
• Global Access: Increasing access in emerging markets enhances revenue base.

Cost and Pricing Trends

Parameter	Current Status	Future Trends
Manufacturing Cost	Decreasing due to bioprocess innovations	Continues to decrease with scale
Pricing Dynamics	Stable with slight declines in some markets due to generics	Upward potential with new formulations and brand positioning

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Comparative Analysis and Strategic Insights

Aspect	Cobicistat	Darunavir	Emtricitabine	Tenofovir Alafenamide (TAF)
Market Maturity	Mature, niche booster	Mature, core HIV drug	Mature, core NRTI	Rapid growth, near-mature
Patent Status	Varies; some expired	Some expiring	Expired in key markets	Patent protection till ~2027
Main Competition	Generic boosters, alternative PK enhancers	Bictegravir-based regimens	Abacavir, TDF	TDF, bempedoic acid
Investment Opportunities	Niche, emerging formulations	Investment in generics, resistance management	Biosimilars, fixed-dose combos	Biosimilars, innovative delivery methods

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FAQs

1. What are the key factors affecting the investment potential of these HIV drugs?

Market size growth, patent expiries, innovative formulations, regulatory changes, and global access are primary drivers. The shift towards safer, once-daily fixed-dose combinations significantly influences revenue trajectories.

2. How does patent expiration impact future revenues?

Patent expiration exposes drugs to generic competition, generally leading to price declines and market share erosion, yet new formulations or improved versions can offset declines and extend revenue streams.

3. What role does pipeline development play in the long-term outlook?

Pipeline advancements, particularly in second-generation drugs with better safety or efficacy profiles, can create new revenue streams and justify investments despite declining sales of older formulations.

4. How does global health policy influence these drugs' markets?

Policy shifts towards universal access and affordability, especially in resource-limited settings, expand markets while potentially compressing profitability in certain regions.

5. What is the competitive edge of TAF over TDF?

TAF offers improved renal and bone safety profiles, making it more attractive in new formulations. Its rapid market adoption indicates high growth potential, but patent protections limit immediate generic competition.

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Key Takeaways

• Market Expansion: The global HIV epidemic's persistence maintains high demand for these drugs, especially as newer, safer formulations replace older versions.

• Patent and Competition Dynamics: Patent cliffs for some products will create short-term revenue declines, but pipeline innovations and formulation enhancements offer compensation.

• Growth Drivers for TAF: Rapid adoption driven by safety benefits propels TAF’s CAGR above 8%, with projected revenues surpassing $11 billion by 2027.

• Investment Risks: Patent expiries, pricing pressures, and regulatory hurdles pose risks, necessitating vigilant portfolio management.

• Opportunities: Second-generation formulations, combination therapies, and emerging markets present promising avenues for revenue growth.

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References

1. UNAIDS. (2022). Global HIV & AIDS statistics — 2022 fact sheet.
2. Gilead Sciences. (2022). Annual Report.
3. ViiV Healthcare. (2022). HIV Portfolio Overview.
4. IQVIA. (2022). Global Markets Reports.
5. World Health Organization. (2021). HIV/AIDS Treatment Guidelines.