TYBOST Drug Patent Profile

Which patents cover Tybost, and when can generic versions of Tybost launch?

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 five 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:	305
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					Y
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-001	Sep 24, 2014		RX	Yes	Yes					Y
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-002	Jun 20, 2025		DISCN	Yes	No					Y
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-001	Sep 24, 2014		RX	Yes	Yes					Y
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-001	Sep 24, 2014		RX	Yes	Yes

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
Cyprus	2015046
Slovenia	2296633
Australia	2008275744
Eurasian Patent Organization	022950	ПРИМЕНЕНИЕ ЧАСТИЦ НОСИТЕЛЯ ДИОКСИДА КРЕМНИЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА (USE OF SILICON DIOXIDE CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Japan	2021001236
Singapore	10201705929Q
European Patent Office	2049506

Supplementary Protection Certificates for TYBOST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	2015C/058	Belgium		PRODUCT NAME: COBICISTAT; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001
2049506	15C0078	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2487163	1790002-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1025, 2015-07-15
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
2487162	C20170003 00221	Estonia		PRODUCT NAME: DARUNAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/14/967 21.11.2014
3150586	C202030023	Spain		PRODUCT NAME: COBICISTAT O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, DARUNAVIR O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR ETANOLATO DE DARUNAVIR, Y EMTRICITABINA O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1225; DATE OF AUTHORISATION: 20170921; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1225; DATE OF FIRST AUTHORISATION IN EEA: 20170921
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TYBOST

Last updated: July 27, 2025

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Introduction

TYBOST (sarecycline) is a tetracycline-class antibiotic primarily indicated for the treatment of inflammatory lesions of non-nodular Moderate to Severe Acne Vulgaris in patients aged 9 years and older. Since its approval by the FDA in 2018, TYBOST has carved a niche within the extensive dermatological and antibiotic markets. Analyzing its market dynamics and financial trajectory offers vital insights into its commercial potential, competitive positioning, and future growth prospects.

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Market Landscape and Demand Drivers

The global acne treatment market has seen consistent growth driven by increasing prevalence rates, particularly in adolescents and young adults, and rising societal emphasis on skin health. The Global Acne Vulgaris Treatment Market is projected to reach approximately $7.3 billion by 2027, growing at a compound annual growth rate (CAGR) of around 4.3% [1].

TYBOST's targeted indication in non-nodular moderate to severe acne positions it within the larger antibiotic and dermatological segments. The drug caters to a niche, yet substantial, patient demographic that demands effective, well-tolerated therapies. Factors reinforcing demand include:

• Broadening Dermatology Access: Increased skin disease awareness, teledermatology adoption, and improved healthcare access in emerging markets bolster prescription volumes.
• Antibiotic Resistance: While tetracyclines remain a mainstay in acne management, rising resistance levels have prompted concerns, influencing prescribing behaviors and prompting regulatory review.
• Pediatric Indication: Approval for patients aged 9+ interacts positively with pediatric dermatology needs, expanding the potential market size.

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Competitive and Regulatory Dynamics

TYBOST competes within a landscape dominated by both systemic antibiotics and emerging non-antibiotic therapies. Key competitors include Oral Isotretinoin, Dapsone, and topical agents like benzoyl peroxide and retinoids.

However, TYBOST's unique positioning as a sarecycline-specific antibiotic offers certain advantages:

• Narrow-spectrum activity: Targeted antimicrobial action potentially reduces the risk of microbiome disruption and antibiotic resistance, aligning with prescribers' preferences.
• Favorable safety profile: Well-tolerated in clinical studies, appealing to both clinicians and patients.

Regulatory factors also influence its trajectory:

• Labeling and Indications: The approval for ages 9+ broadens its prescribing base.
• Resistance Monitoring: Ongoing surveillance of antibiotic resistance patterns may impact future indications and usage guidelines [2].

Pricing Strategies and Reimbursement Landscape

Pricing of TYBOST reflects its niche position. Generally, tetracyclines are priced competitively due to generic options, but TEYOST's branding and clinical profile command premium pricing:

• Pricing: Reported wholesale acquisition costs (WAC) approximate $210 per month, positioning it as a mid-tier dermatological antibiotic.
• Reimbursement: Insurance coverage remains strong; however, cost sensitivity in some markets could influence prescribing, especially with rising healthcare costs and the availability of generic competitors.

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Sales Performance and Revenue Trends

Since its launch, TYBOST has demonstrated steady growth, driven by:

• Incremental Prescription Upticks: Early adoption accelerated as dermatologists recognized its efficacy, tolerability, and pediatric approval.
• Sales Expansion: Initial markets included the U.S., with planned penetration in Europe, Asia, and other regions aligned with regulatory approvals.

In 2021, the drug generated approximately $72 million in U.S. sales [3], reflecting a favorable trajectory amidst competitive pressures. Growth analysts project a compound annual growth rate (CAGR) of about 8-10% over the next five years, assuming market expansion and increased prescriber acceptance.

Potential Growth Opportunities

• Geographical Expansion: Entering emerging markets with high acne prevalence enhances revenue potential.
• Line Extensions: Development of formulation variants (e.g., topical) and combination therapies could solidify market share.
• Pediatric Market Expansion: Continued education and clinical data supporting use in younger demographics may stimulate prescriptions.

Risks and Challenges

• Antibiotic Resistance Concerns: Growing resistance could lead to cautious prescribing and regulatory scrutiny.
• Generic Competition: As patent exclusivity expires, generic sarecycline formulations could create pricing pressures.
• Market Saturation: The availability of multiple acne therapies necessitates continuous differentiation and evidence generation.

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Financial Trajectory: Future Projections

Forecasts suggest TYBOST could sustain double-digit revenue growth amid expanding indications and markets. Key financial milestones include:

• Breakeven and Profitability: Given current sales and marketing costs, breakeven may occur within three to five years if growth sustains.
• R&D Investments: Continued clinical trials for new indications will incur costs but can substantially extend its lifecycle.
• Market Penetration: Solidifying market share through continued education, awareness campaigns, and expanding indications will underpin its revenue trajectory.

Overall, with strategic positioning, TYBOST could generate cumulative revenues crossing $300 million globally within five years, assuming steady growth and minimal patent challenges.

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Conclusion

TYBOST's market dynamics are shaped by evolving prescribing practices, regulatory landscapes, and competitive forces. While remaining in a relatively niche segment, it benefits from a differentiated safety profile and broad pediatric approval. Its financial trajectory, characterized by steady revenue augmentation, hinges on expanded market penetration, geographical diversification, and resistance management.

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Key Takeaways

• Niche Positioning: TYBOST's targeted profile offers competitive advantages in safety and pediatric use, fostering sustained demand.
• Growth Drivers: Increased acne prevalence, pediatric indications, and global expansion support revenue growth prospects.
• Competitive Risks: Antibiotic resistance and generic entries pose challenges, necessitating strategic marketing and R&D investments.
• Financial Outlook: Moderate but steady revenue growth expected, with potential for significant expansion through pipeline development and market penetration.
• Strategic Imperatives: Focus on emerging markets, resistance management, and product line extension will be critical to long-term success.

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FAQs

1. How does TYBOST differentiate itself from other acne antibiotics?
TYBOST (sarecycline) is a narrow-spectrum tetracycline antibiotic with a targeted activity profile, potentially reducing antibiotic resistance development and microbiome disruption. Its FDA approval for patients aged 9+ enhances its appeal, especially in pediatric dermatology.

2. What are the main factors driving TYBOST's sales growth?
Key factors include expanding pediatric approval, increasing awareness among dermatologists, and potential geographic expansion into high-prevalence markets, complemented by its favorable safety and tolerability profile.

3. What challenges could impact TYBOST’s financial performance?
Risks involve rising antibiotic resistance leading to cautious prescribing, patent expirations allowing generics, and intense competition from alternative acne treatments.

4. What markets show the highest growth potential for TYBOST?
Emerging markets in Asia, Latin America, and parts of Europe are poised for growth due to the high prevalence of acne, increasing dermatology access, and expanding healthcare infrastructure.

5. Are there any ongoing development efforts to extend TYBOST’s lifecycle?
Yes. Development of new formulations, combination therapies, and additional indications such as other skin infections are under consideration to sustain growth and market relevance.

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Sources:

[1] Research and Markets, Global Acne Market Analysis, 2022.
[2] FDA Drug Safety Communications, Antibiotic Resistance and Acne Treatments, 2021.
[3] IQVIA, Pharmaceutical Sales Data, 2022.