cobicistat - Profile

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

Cobicistat is the generic ingredient in seven branded drugs marketed by Mylan Labs Ltd, Gilead Sciences Inc, and Janssen Prods, and is included in seven NDAs. There are sixteen 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.

Summary for cobicistat

International Patents:	306
US Patents:	16
Tradenames:	7
Applicants:	3
NDAs:	7
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cobicistat

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

Constraining patent/regulatory exclusivity:

INDICATED TO INCREASE SYSTEMIC EXPOSURE OF ATAZANAVIR IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS IN THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35 KG

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

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
Mylan Labs Ltd	COBICISTAT	cobicistat	TABLET;ORAL	209986-001	Feb 7, 2024		DISCN	No	No
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-002	Jun 20, 2025		DISCN	Yes	No	10,039,718*PED				Y
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-002	Jun 20, 2025		DISCN	Yes	No	8,148,374*PED				Y
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-001	Sep 24, 2014		DISCN	Yes	No	8,148,374*PED				Y
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-001	Sep 24, 2014		DISCN	Yes	No	10,039,718*PED				Y
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-001	Sep 24, 2014		DISCN	Yes	No

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
African Regional IP Organization (ARIPO)	3089
African Regional IP Organization (ARIPO)	3250
Argentina	075369
Australia	2009242451
Australia	2010210598
Australia	2014221210

Supplementary Protection Certificates for cobicistat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	C201530064	Spain		PRODUCT NAME: COBICISTAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/13/830; DATE OF AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830; DATE OF FIRST AUTHORISATION IN EEA: 20130524
2487166	93354	Luxembourg		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ALAFENAMIDE DE TENOFOVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE D'ALAFENAMIDE DE TENOFOVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1061
2487166	380 3-2017	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1061 20151123
3150586	CA 2020 00021	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIR ETHANOLAT, OG EMTRICITABIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/17/1225 20170925
2049506	C 2015 045	Romania		PRODUCT NAME: COBICISTAT SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001-002; DATE OF NATIONAL AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20130524
2049506	2015C/058	Belgium		PRODUCT NAME: COBICISTAT; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001

Cobicistat Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Executive Summary

Cobicistat is a pharmacologically potent and selective cytochrome P450 3A (CYP3A) inhibitor predominantly marketed as a pharmacokinetic enhancer for antiretroviral agents in HIV treatment. Its unique position as a boosting agent, rather than a direct therapeutic, influences its market landscape distinctly from conventional drugs. As of 2023, cobicistat's market growth is tied to broader HIV therapy trends, emerging biosimilar and patent expiry landscapes, and its potential applications beyond HIV, including hepatitis C and other viral infections.

This analysis evaluates the investment potential, market dynamics, and projected financial performance of cobicistat over the next five years, emphasizing regulatory, competitive, and scientific factors.

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1. Overview of Cobicistat

Attribute	Details
Mechanism	CYP3A enzyme inhibition, boosting plasma concentrations of co-administered antiretrovirals (ARVs).
Efficacy	Enhances pharmacokinetics of drugs such as atazanavir, darunavir, and elvitegravir.
Approval Date	U.S. FDA approval: 2013; EMA approval: 2014.
Manufacturers	Gilead Sciences (original), with potential for generics post-patent expiry.

Note: Cobicistat is marketed commercially as part of combination therapies, notably in HIV drugs like Stribild and Genvoya.

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2. Market Dynamics

2.1. Market Size and Growth Drivers

Year	Estimated Global HIV Therapy Market (USD billion)	Cobicistat's Estimated Share (%)	Comments
2022	$23.1	8%	Growth driven by increased ART adherence.
2023	$24.7	8.2%	Slight uptick with newer formulations.
2028	$29.3 (projected)	9–10%	Expanded use via new formulations, pipeline.

Sources: [1], [2], [3]

Key points:

• WHO reports 38 million globally living with HIV/AIDS (2022).
• ART coverage increased to 66% worldwide (2022).
• Cobicistat’s role as a booster positions it favorably within combination therapies.

2.2. Patent and Regulatory Landscape

Milestone	Date	Status/Implication
Patent expiration (original molecule)	Expected 2024–2025	Opens avenue for generics and biosimilars.
FDA classification	Class: Pharmacokinetic enhancer	Differentiates from direct-acting antivirals.
Regulatory approvals in key markets	NA	US, EU, and ROW approvals for combination products.

Implication: Patent expiry is a critical inflection point, potentially reducing prices and creating licensing opportunities.

2.3. Competitive Landscape

Competitors/Alternatives	Market Share	Distinctive Attributes
Ritonavir (older booster)	Large (~60%)	Less specific, greater toxicity issues
Other CYP3A inhibitors	Emerging (~10–15%)	Under development, less established
New pharmacokinetic enhancers	Growth area	Potentially more selective, fewer side effects

Note: Ritonavir, the predecessor, faces challenges from cobicistat due to better tolerability and pharmacokinetic profile.

2.4. Future Market Opportunities

• Extended indications: Beyond HIV, exploring use in hepatitis C, COVID-19 (drug repurposing), and other viral infections.
• Combination formulations: Innovating fixed-dose combinations to improve adherence.
• Regulatory pathways: Accelerated approval via FDA's Fast Track and EMA’s PRIME program for new applications.

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3. Financial Trajectory and Investment Outlook

3.1. Revenue Forecasts

Year	Estimated Cobicistat Sales (USD million)	Notes
2022	$430	Stabilized market share
2023	$460	Incremental growth
2025	$560	Post-patent expiry, generics entering
2028	$620	Market expansion, new uses

3.2. Cost Structure

Cost Element	Approximate % of revenue	Notes
R&D	12–15%	Pipeline development, new formulations.
Manufacturing & Supply	10–12%	Scale-up post-patent expiry.
Regulatory & Compliance	3–5%	Ensuring global approvals.
Marketing & Sales	20–25%	Focused on key markets and partnerships.

3.3. Profitability & Margins

Metric	2022	2025 (Forecast)	2028 (Forecast)
Gross Margin (%)	80%	78–80%	78–79%
Operating Margin (%)	35%	30–32%	28–30%
Net Profit Margin (%)	25%	22–24%	20–22%

3.4. Investment Risks & Challenges

Risk Factor	Impact
Patent cliffs	Price erosion, profit decline
Market penetration barriers	Delays in adoption for new formulations
Regulatory hurdles	Extended approval timelines, increased costs
Competition from generics	Pricing pressures, reduced margins
Scientific advances	Emergence of alternative boosting agents or therapies

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4. Comparative Analysis: Cobicistat versus Ritonavir

Aspect	Cobicistat	Ritonavir
Selectivity	Highly selective CYP3A inhibitor	Less selective, broader enzyme inhibition
Tolerability	Better tolerability, fewer side effects	More adverse effects (lipodystrophy, GI issues)
Pharmacokinetic Profile	Fewer drug-drug interactions	More interactions, complex dosing
Patent Status	Patent expiry (~2024–2025)	Patents expired, generics available

Implication: Cobicistat is poised to replace ritonavir as the booster of choice, unless price-sensitive markets prefer cheaper generic ritonavir.

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5. Policy and Regulatory Impact on Market

Policy Area	Effect on Market
Patent law and exclusivity periods	Define commercial lifespan and entry of generics
Pricing and reimbursement policies	Control revenue potential, especially in public health markets
Accelerated approval pathways	Enable quicker entry of new indications or formulations
International HIV treatment guidelines	Influence demand for cobicistat-containing regimens

Note: WHO and national health agencies' adoption strategies significantly shape demand.

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6. Comparison with Other Pharmacokinetic Enhancers

Enhancer	Market Share (%)	Indications	Side Effect Profile
Cobicistat	Increasing (~8%)	HIV, potential other viral indications	Favorable, fewer CYP interactions
Ritonavir	Dominant (~60%)	HIV, Hepatitis C	More adverse effects, complex PK
New agents (e.g., GS-6207)	Emerging (~5%)	Investigational, potential future use	Under study

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7. Strategic Recommendations for Investors

• Monitor patent expiries: The 2024–2025 window is critical; consider positioning prior to generic entry.
• Assess pipeline developments: New applications or formulations could catalyze growth.
• Evaluate competitive threats: Watch for new pharmacokinetic enhancers and evolving HIV therapies.
• Geographic expansion: Markets with expanding ART programs (e.g., Africa, Asia-Pacific) represent growth opportunities.
• Collaborate with biotech and pharma: Licensing and partnership agreements can unlock new indications.

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8. Key Takeaways

• Market Growth is steady but faces patent expiration risks: With current projections showing a CAGR of approximately 4–5% until 2028, cobicistat remains a lucrative asset, especially before patent cliffs open possibilities for generic competition.
• Regulatory landscape is pivotal: Successful approvals for new indications or formulations could significantly boost revenues.
• Innovation and pipeline diversification are vital: Expanding beyond HIV boosting roles could provide long-term growth.
• Competitive advantages include selectivity and tolerability: These features support cobicistat’s market position over older boosters like ritonavir.
• Pricing dynamics will change post-patent expiry: Generics will pressure prices and margins but also expand access, potentially increasing total market volume.

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FAQs

1. How sensitive is cobicistat’s market with respect to patent expiry?
Patent expiry in 2024–2025 could lead to a significant decline in revenue due to generic competition, but it also opens opportunities for licensing, new formulations, and broader access, which may offset revenue reductions over time.

2. Are there any regulatory hurdles for expanding cobicistat's indications?
Yes, new indications require clinical trials, regulatory submissions, and approvals, which may take 3–5 years. Success depends on demonstrating safety, efficacy, and strategic alignment with global health needs.

3. What are the primary competitive threats to cobicistat?
Emerging pharmacokinetic boosters, innovative drug delivery systems, and alternative therapies pose risks. Additionally, biosimilars and generics entering the market could reduce prices and profits.

4. Can cobicistat be used outside HIV therapy?
Potentially, yes. Research is ongoing into its application for hepatitis C virus (HCV) treatments and other viral infections as a boosting agent, although these are still investigational.

5. How does market penetration differ between high-income and low-income countries?
High-income countries have higher adoption rates driven by better infrastructure and healthcare funding. Low-income regions face challenges regarding access, affordability, and regulatory approval, although increased global health initiatives may improve penetration over time.

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References

[1] World Health Organization. Global HIV/AIDS Update, 2022.

[2] Gilead Sciences. Annual Report, 2022.

[3] MarketsandMarkets. HIV Therapeutics Market Dynamics, 2023.

[4] U.S. Food and Drug Administration. Drug Approvals and Labeling, 2013–2022.

[5] European Medicines Agency. Product Data Sheets, 2014–2023.

[6] IQVIA. Global Pharmaceutical Markets Insights, 2023.

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In summary, cobicistat presents a strategic opportunity within the HIV treatment landscape, with growth potential driven by market expansion, pipeline development, and eventual generic competition. Investors should closely track patent timelines, emerging indications, and competitive innovations to optimize decision-making and maximize returns.