COBICISTAT; DARUNAVIR ETHANOLATE - Generic Drug Details

What are the generic drug sources for cobicistat; darunavir ethanolate and what is the scope of freedom to operate?

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

Cobicistat; darunavir ethanolate has three hundred and fifty-three patent family members in forty-one countries.

Two suppliers are listed for this compound.

Summary for COBICISTAT; DARUNAVIR ETHANOLATE

International Patents:	353
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COBICISTAT; DARUNAVIR ETHANOLATE
DailyMed Link:	COBICISTAT; DARUNAVIR ETHANOLATE at DailyMed

Pharmacology for COBICISTAT; DARUNAVIR ETHANOLATE

Drug Class	Cytochrome P450 3A 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 Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COBICISTAT; DARUNAVIR ETHANOLATE

D08AX	Other antiseptics and disinfectants
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

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

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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

V03AZ	Nerve depressants
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for COBICISTAT; DARUNAVIR ETHANOLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREZCOBIX	Tablets	cobicistat; darunavir ethanolate	800 mg/150 mg	205395	1	2020-07-24

US Patents and Regulatory Information for COBICISTAT; DARUNAVIR ETHANOLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-002	Mar 21, 2025		RX	Yes	No	10,039,718		Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-002	Mar 21, 2025		RX	Yes	No	7,700,645*PED				Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-002	Mar 21, 2025		RX	Yes	No	8,148,374		Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	8,148,374		Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	7,700,645*PED				Y

Expired US Patents for COBICISTAT; DARUNAVIR ETHANOLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	RE43596*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	5,843,946*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	RE43802*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	RE42889*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	8,597,876*PED

EU/EMA Drug Approvals for COBICISTAT; DARUNAVIR ETHANOLATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Rezolsta	darunavir, cobicistat	EMEA/H/C/002819Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.Genotypic testing should guide the use of Rezolsta.	Authorised	no	no	no	2014-11-19

International Patents for COBICISTAT; DARUNAVIR ETHANOLATE

Country	Patent Number	Title	Estimated Expiration
New Zealand	573060
South Korea	20100040896
Japan	2019059790
Portugal	2049506
Hong Kong	1164737	包括埃替拉韋， ，恩曲他濱和替諾福韋的雙層片劑 (BILAYER TABLETS COMPRISING ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR COBICISTAT)

Supplementary Protection Certificates for COBICISTAT; DARUNAVIR ETHANOLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487166	132017000002828	Italy		PRODUCT NAME: COBICISTAT O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO E TENOFOVIR ALAFENAMIDE O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
2049506	61/2015	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527
2487163	CA 2017 00003	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG ATAZANAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER ATAZANAVIRSULFAT; REG. NO/DATE: EU/1/15/1025/001-002 20150715
2487166	17C1001	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET TENOFOVIR ALAFENAMIDE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2049506	C02049506/01	Switzerland		PRODUCT NAME: COBICISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62673 18.10.2013

Market Dynamics and Financial Trajectory for COBICISTAT; DARUNAVIR ETHANOLATE

Last updated: July 28, 2025

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Introduction

The pharmaceutical landscape governing antiretroviral therapies (ART) continues to evolve amidst scientific advancements, regulatory adaptations, and market demand shifts. Among emerging treatments, Cobicistat and Darunavir Ethanolate combination presents a promising profile driven by the global imperative to optimize HIV management. This analysis explores the market dynamics, competitive positioning, regulatory environment, and financial prospects for these drugs.

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Pharmacological Profile and Therapeutic Role

Cobicistat functions as a pharmacokinetic enhancer, boosting the efficacy of other antiretrovirals, notably Darunavir Ethanolate, a protease inhibitor with high genetic barrier activity against HIV-1. Combined, these agents streamline HIV treatment regimens by reducing pill burden and improving adherence. Their partnership aligns with contemporary therapeutic goals emphasizing potency, simplicity, and tolerability.

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Market Introduction and Competitive Landscape

The combination of Cobicistat and Darunavir Ethanolate entered the market amidst a crowded CHIV drug space, characterized by established agents such as Dolutegravir, Rilpivirine, and boosted protease inhibitors like Atazanavir. Market entry timing, regulatory approval status, and patent protections critically influence initial market share.

Key competitors include:

• Biktarvy (Genvoya), a single-tablet regimen integrating bictegravir, emtricitabine, and tenofovir alafenamide (TAF)
• Darunavir-based regimens with ritonavir boosting
• Other pharmacokinetic enhancers like Cobimetinib and Elvitegravir

Despite intense competition, the approval of Cobicistat/Darunavir Ethanolate combination by regulatory bodies such as FDA and EMA in recent years underscores its potential to carve a niche — particularly in patients with resistance profiles or intolerance to first-line therapies.

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Market Dynamics

Prevalence and Demand Drivers

The global HIV epidemic sustains high demand for effective ART. According to UNAIDS, over 38 million people globally are living with HIV, with significant treatment coverage predominantly in developed regions but also expanding in low- and middle-income countries (1). The need for potent, tolerable, and simplified regimens continues to propel market growth, especially as the emphasis shifts toward lifelong management.

Regulatory and Policy Influences

Regulatory authorities in key markets have expedited approvals for innovative HIV drugs, including fixed-dose combinations integrating Cobicistat. Policies emphasizing "test and treat" strategies boost patient volumes, thereby expanding market segments.

Pricing and Reimbursement Dynamics

Pricing strategies impact market penetration. Patent protections allow monopoly pricing initially; however, patent cliffs, generic entry, and patent litigations can significantly alter cost structures and accessibility over time.

Reimbursement policies differ globally, with developed markets offering broader coverage, thus accelerating adoption compared to resource-constrained regions.

Emerging Trends

• Personalized Medicine: Resistance testing increases demand for tailored regimens, elevating the position of drugs like Darunavir Ethanolate.
• Long-acting Formulations: Innovations such as injectables challenge oral regimens but also create opportunities for combination drugs to be formulated in novel delivery systems.
• Combination Flexibility: Developing multi-drug fixed-dose therapies enhances adherence, driving uptake for Cobicistat and Darunavir Ethanolate formulations.

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Financial Trajectory and Revenue Forecasts

Market Size Projections

The global HIV pharmacotherapy market valued approximately USD 17 billion in 2022, is anticipated to grow at a compound annual growth rate (CAGR) of 4-6% through 2030, driven by increasing patient access and innovation (2). The specific niche for Cobicistat-based Darunavir Ethanolate is poised to expand beyond initial mono-releases into broader combination packages.

Revenue Streams

Major revenue sources include:

• Direct sales from proprietary formulations
• Generic competition post-patent expiry
• Partnerships and licensing agreements

Innovative formulations, especially fixed-dose combinations, command premium pricing. For example, Darunavir/cobicistat regimens retail at approximately USD 600–800/month in developed markets, reflecting their therapeutic value and convenience.

Impact of Patent and Generic Entry

Patents extending into the late 2020s and early 2030s provide a window of exclusivity. The expiration of key patents may trigger a decline in revenues unless new formulations or indications emerge. However, patent litigation and secondary patents often prolong exclusivity, offering financial stability.

Market Penetration and Sales Volume

Market penetration rates hinge on factors like healthcare infrastructure, physician acceptance, and patient adherence. In countries with established HIV treatment programs, initial adoption may reach 20-30% of eligible patients within the first five years post-launch, with potential growth as drug prices decline and generics enter.

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Regulatory and Patent Considerations

The drugs have secured regulatory approval in multiple jurisdictions, but ongoing patent litigations and regulatory filings influence revenue security. Navigating regulatory pathways for biosimilars and generics remains critical in sustaining long-term financial health.

Furthermore, regulatory agencies are increasingly adopting accelerated approval pathways, especially during health emergencies, influencing commercialization timelines.

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Conclusion

The market for Cobicistat and Darunavir Ethanolate is characterized by robust demand, evolving competitive dynamics, and significant revenue potential. Rapid adoption in regions with high HIV prevalence and strong healthcare infrastructure, combined with strategic patent management and formulation innovation, underpin promising financial trajectories. However, competition from emerging therapies and biosimilars necessitates continual innovation and market adaptation.

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Key Takeaways

• Market Growth: The global HIV treatment market remains expanding, with Cobicistat and Darunavir Ethanolate positioned as vital components for specific patient segments.
• Competitive Edge: Their combination offers improved compliance and resistance management, vital in highly competitive therapies.
• Pricing Strategies: Premium priced formulations sustain short-term revenue but face pressure from generics and biosimilars.
• Regulatory Outlook: Expedited approvals and patent protections underpin revenue stability, but patent cliffs require strategic planning.
• Future Opportunities: Development of long-acting formulations and personalized regimens will shape future market dynamics and financial outcomes.

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FAQs

1. What factors influence the market penetration of Cobicistat and Darunavir Ethanolate?
Market penetration depends on regulatory approvals, healthcare provider acceptance, patient adherence, pricing strategies, and regional HIV prevalence.

2. How does patent expiry impact the financial trajectory of these drugs?
Patent expiry generally leads to generic competition, reducing prices and potentially decreasing revenues unless protected by secondary patents or new formulations.

3. Are there notable regulatory hurdles for these drugs?
Regulatory challenges include approval delays in certain jurisdictions, demonstrating safety and efficacy, and compliance with evolving guidelines, especially concerning long-term safety data.

4. How do emerging HIV treatments affect the market outlook for Cobicistat and Darunavir Ethanolate?
Innovations such as long-acting injectables and advancements in integrase inhibitors may limit growth unless these drugs are integrated into new combination therapies or targeted for resistant strains.

5. What are the key strategies for maintaining competitive advantage?
Continued innovation, strategic patent management, expanding indications, and developing combination formulations tailored to specific patient populations are vital for sustained market relevance.

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References

1. UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet.
2. MarketsandMarkets. HIV/AIDS therapeutics market analysis.