COBICISTAT - Generic Drug Details

What are the generic drug sources for cobicistat and what is the scope of patent protection?

Cobicistat is the generic ingredient in six branded drugs marketed by Mylan Labs Ltd, Gilead Sciences Inc, and Janssen Prods, and is included in six NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cobicistat has three hundred and six patent family members in forty-one countries.

There are five drug master file entries for cobicistat. One supplier is listed for this compound.

Summary for COBICISTAT

International Patents:	306
US Patents:	18
Tradenames:	6
Applicants:	3
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	135
Patent Applications:	3,298
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COBICISTAT
What excipients (inactive ingredients) are in COBICISTAT?	COBICISTAT excipients list
DailyMed Link:	COBICISTAT at DailyMed

Recent Clinical Trials for COBICISTAT

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

Sponsor	Phase
Instituto Mexicano del Seguro Social	PHASE4
Fore Biotherapeutics	EARLY_PHASE1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	EARLY_PHASE1

See all COBICISTAT clinical trials

Pharmacology for COBICISTAT

Drug Class	Cytochrome P450 3A Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for COBICISTAT

Anti-HIV Agents

Cytochrome P-450 CYP3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COBICISTAT

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

Paragraph IV (Patent) Challenges for COBICISTAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TYBOST	Tablets	cobicistat	150 mg	203094	1	2016-11-14

US Patents and Regulatory Information for COBICISTAT

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	7,390,791		Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	10,039,718		Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	9,891,239*PED				Y

EU/EMA Drug Approvals for COBICISTAT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Tybost	cobicistat	EMEA/H/C/002572Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.	Authorised	no	no	no	2013-09-19

International Patents for COBICISTAT

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	019893
Spain	2796275
Slovenia	3150586

Supplementary Protection Certificates for COBICISTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487162	CA 2017 00002	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121
2049506	801	Finland
2487166	CA 2017 00004	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123

Market Dynamics and Financial Trajectory for COBICISTAT

Last updated: July 28, 2025

Introduction

Cobicistat is a pharmaceutically active compound primarily utilized as a pharmacokinetic enhancer, or "booster," in antiretroviral therapy (ART) for HIV treatment. Since its approval by the U.S. Food and Drug Administration (FDA) in 2014 as part of combination therapies, cobicistat has gained a pivotal role in HIV management. Its mechanism, which involves inhibiting the cytochrome P450 3A (CYP3A) enzyme, prolongs the half-life and enhances the absorption of concomitant medications such as integrase inhibitors. This strategic role has influenced both the drug’s market dynamics and its financial prospects.

Market Landscape and Demand Drivers

The global HIV therapeutics market has demonstrated consistent growth, projected to reach USD 37 billion by 2027, driven by increasing prevalence, improved treatment regimens, and growing access in emerging markets [1]. Within this framework, cobicistat's adoption as a pharmacokinetic booster in fixed-dose combinations (FDCs) significantly contributes to market demand.

Industry Competition and Positioning

Cobicistat's chief competitors are ritonavir and other booster agents used in HIV ART. However, cobicistat offers advantages over ritonavir, notably fewer drug-drug interactions and better tolerability, making it more attractive for combination therapies. Key formulations include Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) and Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate). These combination drugs dominate the market, accounting for a large share of prescribed regimens.

Patent Status and Generic Competition

Patents on cobicistat-containing formulations have historically provided exclusivity, enabling premium pricing. However, patent expirations or potential challenges threaten future market control, particularly in emerging countries. The entry of generic boosters could commoditize the market but may also lead to price reductions and margin pressures for patent-holding companies.

Market Dynamics Impacting Cobicistat's Financial Trajectory

Regulatory Approvals and Label Expansion

Regulatory bodies such as the FDA and EMA have approved cobicistat for use in multiple fixed-dose combinations beyond initial formulations. Expanded indications and formulations, including pediatric and generic versions, can significantly influence market accessibility and revenue streams.

Evolving Treatment Paradigms

The shift towards integrase inhibitor-based regimens enhances cobicistat's relevance, as it is integral to several once-daily, single-pill regimens. The continued preference for these regimens supports stable revenue projections.

Pricing Trends and Market Penetration

Pricing strategies for cobicistat-containing drugs have historically leveraged premium positioning due to patent protections and clinical benefits. Ongoing negotiations, payer policies, and government health programs impact revenue potential, especially in developing nations.

Emerging Markets and Access Initiatives

Increasing HIV prevalence in Africa, Asia, and Latin America presents growth opportunities. International initiatives aiming to expand ART coverage promote demand for cost-effective, simplified regimens containing cobicistat.

Research and Developmental Activity

Research into novel booster agents or alternative pharmacokinetic enhancers could alter the competitive landscape. Nonetheless, current pipeline activity for cobicistat itself remains limited, focusing instead on combination therapies, indicating a focus on maintaining its existing market share rather than product innovation.

Financial Trajectory Outlook

Revenue Forecasts

Given its entrenched role in high-quality ART regimens, cobicistat's revenue is expected to remain stable in mature markets, with potential incremental growth driven by the expansion of combination therapies and increased access in emerging markets. Globally, revenues from cobicistat-based formulations are projected to grow at a compound annual growth rate (CAGR) of approximately 3-5% over the next five years [2].

Profitability Factors

Profit margins hinge on patent protections, manufacturing costs, and competition. Patent expirations in key markets could trigger revenue declines, though expansion into new markets and formulations may offset this. Generic entry, if timely and strategic, might reduce costs and facilitate wider access, but could compress profit margins for innovators.

Risks Influencing Financial Trajectory

• Patent Expiry and Litigation: Potential patent challenges may erode market exclusivity.
• Market Penetration Barriers: Pricing pressures and payer policies could limit growth.
• Competition from Newer Boosters: Emerging pharmacokinetic enhancers may diminish cobicistat’s role.
• Regulatory Changes: Revisions in clinical guidelines affecting ART regimens could impact demand.

Strategic Implications for Stakeholders

Investors and pharmaceutical companies should monitor patent landscapes closely, especially as the expiration of key patents approaches. Diversifying into emerging markets, optimizing manufacturing for cost efficiency, and investing in combination therapies remain critical strategies for maximizing cobicistat's financial potential. Additionally, collaborations for access programs and pricing negotiations will influence long-term profitability.

Conclusion

Cobicistat's current market dynamics are shaped by its essential role in modern HIV treatment regimens, regulatory positioning, and competitive landscape. While mature markets provide stable revenue streams, patent expirations and emerging competitors pose risks to future growth. The overall financial trajectory hinges on regulatory developments, market expansion in emerging economies, and strategic positioning within the evolving HIV therapeutic landscape.

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Key Takeaways

• Stable Market Position: Cobicistat remains integral to several high-prescription HIV regimens, supporting consistent revenues.
• Growth Opportunities: Expanding access in emerging markets and formulation diversification hold potential for incremental growth.
• Patent and Competition Risks: Patent expirations and introduction of generic boosters may pressure margins but also widen access.
• Evolving Treatment Protocols: The preference for integrase inhibitor-based regimens favors cobicistat’s continued relevance.
• Strategic Focus: Cost management, market expansion, and access initiatives are vital for maximizing future financial returns.

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FAQs

1. What is the primary therapeutic role of cobicistat?
Cobicistat functions as a pharmacokinetic booster in HIV treatment, inhibiting CYP3A enzymes to enhance absorption of co-administered antiretrovirals, allowing for simplified, once-daily dosing.

2. How does patent expiration impact cobicistat’s market?
Patent expirations open the market to generic competitors, potentially reducing pricing and revenues for original manufacturers. Strategic patent litigation and timing are critical to maintaining exclusivity.

3. What are the main challenges facing cobicistat’s growth?
Key challenges include patent cliffs, competition from alternative boosters or new therapeutic agents, regulatory shifts favoring novel regimens, and pricing pressures in both developed and emerging markets.

4. How might emerging markets influence cobicistat’s future revenues?
Growing HIV prevalence and global health initiatives increase demand for affordable ART regimens containing cobicistat, offering significant growth prospects if market access and pricing barriers are managed effectively.

5. Are there any pipeline developments for cobicistat?
Current development efforts focus on optimizing existing formulations and expanding approved combinations rather than new chemical entities, aiming to consolidate its market position in existing therapies.

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References

[1] Mordor Intelligence. (2022). Global HIV Therapeutics Market.
[2] IQVIA. (2022). The Impact of Patent Expirations on HIV Drug Market Trends.