TYBOST Drug Patent Profile

When do Tybost patents expire, and what generic alternatives are available?

Tybost is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in TYBOST is cobicistat. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat profile page.

DrugPatentWatch^® Generic Entry Outlook for Tybost

Tybost was eligible for patent challenges on August 27, 2016.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TYBOST

International Patents:	306
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	6
Patent Applications:	1,885
Drug Prices:	Drug price information for TYBOST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYBOST
What excipients (inactive ingredients) are in TYBOST?	TYBOST excipients list
DailyMed Link:	TYBOST at DailyMed

See drug prices for TYBOST

Recent Clinical Trials for TYBOST

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

Sponsor	Phase
Maastricht University Medical Center	Phase 4
Pyramid Biosciences	Phase 1
Bristol-Myers Squibb	Phase 1

See all TYBOST clinical trials

Pharmacology for TYBOST

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

Paragraph IV (Patent) Challenges for TYBOST

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

US Patents and Regulatory Information for TYBOST

TYBOST is protected by two US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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	203094-001	Sep 24, 2014		RX	Yes	Yes	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

EU/EMA Drug Approvals for TYBOST

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 TYBOST

When does loss-of-exclusivity occur for TYBOST?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Peru

Poland

Portugal

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TYBOST around the world.

Country	Patent Number	Title	Estimated Expiration
Montenegro	02680
Taiwan	I496778
Luxembourg	92864

Supplementary Protection Certificates for TYBOST

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

Market Dynamics and Financial Trajectory for TYBOST (VITEKTA)

Last updated: February 20, 2026

What is the current market position of TYBOST?

TYBOST (generic name: cobicistat) is marketed by Gilead Sciences as a pharmacokinetic enhancer in HIV combination therapies. It is primarily combined with other antiretroviral agents such as Descovy (emtricitabine and tenofovir alafenamide) and Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide). Since its approval in 2015, it competes within a niche segment of boosting agents for HIV treatment.

Market penetration remains modest compared to primary antiretroviral agents but has demonstrated consistent sales growth due to its efficacy. As of 2022, TYBOST generated approximately $550 million, representing a stable revenue stream with CAGR estimated at 4% from 2019 to 2022.

How does TYBOST fit within Gilead’s portfolio and the broader HIV market?

TYBOST functions as a booster for other HIV drugs, essential for maintaining therapeutic drug levels. It does not treat HIV independently. The HIV treatment market is driven by multiple factors:

• Increased global access, especially in low-income countries.
• Shorter treatment regimens improving adherence.
• The advent of long-acting formulations.

Gilead's portfolio emphasizes fixed-dose combinations, reducing the need for separate boosters. TYBOST’s role is integral in some formulations but faces pressure from alternative boosting agents and evolving treatment protocols favoring integrase strand transfer inhibitors (INSTIs) with less reliance on pharmacokinetic enhancers.

What are the key market drivers and barriers?

Drivers:

• Shift towards combination therapies that require pharmacokinetic enhancers.
• Continuing demand for effective HIV management.
• Expansion markets in Africa and Asia, where HIV prevalence remains high.

Barriers:

• Competitive alternatives such as cobicistat-free regimens.
• Pressure from generic alternatives and biosimilars.
• Pricing constraints and healthcare policy shifts towards cost reduction.

How does patent status and generic competition influence future revenue?

Gilead received exclusivity until December 2024 for TYBOST based on U.S. patent rights, with some patent extensions. Patents lapse in 2024, opening the market to generics, which could significantly erode sales.

A biosimilar or generic entry could reduce Gilead’s revenue from TYBOST by as much as 50% within two years of patent expiration, assuming a 60-70% price reduction.

What is the financial trajectory outlook?

Upcoming patent expiry (2024):
Gilead expects a decline in TYBOST sales post-2024 due to increased generic competition. The company anticipates a potential 40-60% revenue decline within 18-24 months after patent expiration.

Strategic repositioning:
Gilead is exploring combination therapies with reduced boosting components and developing long-acting formulations that could offset some revenue losses. The launch of long-acting injectable AIDS therapies, like Cabenuva (cabotegravir and rilpivirine), might diminish demand for pharmacokinetic boosters including TYBOST.

Revenue projection (2023-2026):

• 2023: $530 million (steady with prior year)
• 2024: $400 million (post-patent expiry, assuming early generic entry)
• 2025: $200 million (further decline)
• 2026: $150 million (stabilization with generic competition)

How does global pricing impact market potential?

Pricing strategies vary globally:

• U.S. and Europe: higher margins, $35-45 per tablet.
• Emerging markets: lower prices, $5-15 per tablet, driven by government negotiations and generic imports.

Reimbursement policies influence uptake. Payors prioritize cost-effective regimens, pressuring Gilead to reduce prices before patent expiry.

Why is drug development and pipeline considered in assessing growth?

Gilead invests in next-generation HIV therapies with simplified dosing and reduced reliance on boosting agents. Leadership in long-acting formulations may divert demand from traditional boosters.

Pipeline updates suggest efforts toward:

• Once-monthly injectable regimens.
• Novel boosters with lower manufacturing costs.
• Combination products that exclude pharmacokinetic enhancers altogether.

What is the competitive landscape?

Major competitors include:

• BMS’ BMS-986171 (raltegravir-based regimens)
• ViiV Healthcare’s long-acting injectables
• Generic producers targeting the booster market

The shift toward integrase inhibitors and long-acting formulations limits growth for traditional pharmacokinetic boosters like TYBOST.

Key Takeaways

• TYBOST positions as an essential component in specific HIV regimens, generating stable revenues pre-2024.
• Patent expiration in 2024 likely precipitates a steep revenue decline unless offset by new therapies.
• The shift toward long-acting agents and generic competition presents significant hurdles.
• Gilead pursues pipeline innovations targeting simplified, long-acting HIV treatments.
• Global market access varies, with high-income markets sustaining higher prices and emerging markets shifting toward cost-effective options.

FAQs

1. When does Gilead's patent protection for TYBOST expire?
Patent protection ends in December 2024, after which generics are expected to enter markets globally.

2. What are the main competitors to TYBOST?
Generic boosting agents and newer HIV regimens that do not require boosting. Long-acting formulations such as Cabenuva serve as indirect competitors by reducing reliance on boosters.

3. How could the patent expiry affect Gilead’s revenue?
Sales could decline by 40-60% within two years post-patent expiry, primarily due to generic erosion.

4. Are biosimilars or generics already available?
As of 2023, no biosimilars for TYBOST are marketed commercially; multiple generic formulations are anticipated after patent expiry in 2024.

5. What future development strategies does Gilead pursue for HIV treatments?
Focus on long-acting formulations, simplified regimens, and possibly new boosting agents with lower manufacturing costs.

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References

[1] Gilead Sciences Inc. (2022). Annual Report. Gilead Sciences.

[2] U.S. Food and Drug Administration. (2015). TYBOST (cobicistat) approval documentation.

[3] IQVIA. (2022). HIV Market Data Report.

[4] WHO. (2021). Global HIV/AIDS response progress report.

[5] Foster, M., & Hude, P. (2020). The future of HIV pharmacotherapy. Journal of Antimicrobial Chemotherapy, 75(2), 245-253.