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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 22, 2026. This may change due to patent challenges or generic licensing.

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:	1,617
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

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

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

NDA:

203094

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.

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.

This potential generic entry date is based on 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.

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

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		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

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

Supplementary Protection Certificates for TYBOST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	CA 2015 00060	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
2049506	PA2015040	Lithuania		PRODUCT NAME: COBICISTATUM; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
2049506	92864	Luxembourg		PRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 20130527
2049506	15C0078	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2049506	300780	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2049506	61/2015	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527

Last updated: June 22, 2026

Market dynamics and financial trajectory for TYBOST (cobicistat)

Executive summary: TYBOST (cobicistat) functions as a pharmacokinetic enhancer for HIV antiretroviral regimens and competes indirectly through the availability of alternative boosters (ritonavir-based and, to a lesser extent, other boosting strategies). The commercial trajectory is tied to (1) patient volume on boosted combination ART, (2) regimen selection by prescribers and payors, (3) changes in guideline-driven use of darunavir-boosted and other cobicistat-containing regimens, and (4) competitive pressure from once-daily fixed-dose combinations that can substitute for cobicistat monotherapy or co-dispensed use. TYBOST’s revenue exposure is therefore primarily “share-of-use” within boosted ART rather than direct class substitution by a single rival product.

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How does TYBOST (cobicistat) make money in the market?

Direct answer: TYBOST revenue depends on the number of prescriptions where cobicistat is used as the booster component, typically alongside specific HIV agents that require boosting for exposure and tolerability.

Key commercial mechanics

• Booster role, not a standalone regimen. TYBOST is typically prescribed to enable or optimize exposure of other antiretrovirals (most notably in darunavir-based combinations). This makes demand downstream of combination regimen selection rather than independent uptake.
• Regimen stickiness vs. booster switches. Once a patient is stable on a boosted regimen, switching boosters is uncommon unless efficacy changes, tolerability issues arise, or prescriber behavior changes due to guideline or formulary updates.
• Formulary and pharmacy channel effects. Access is driven by pharmacy benefit design, preferred-product lists, and substitution rules within boosted HIV products. PBM contracting can materially swing share even if total “boosted ART” demand is stable.

Financial implication

A booster product’s financial trajectory generally tracks:

• Total treated patient pool using boosted regimens,
• Switching intensity (frequency of regimen changes),
• Pricing net of rebates and contract coverage,
• Migration to fixed-dose combinations that reduce cobicistat’s “separate line item” footprint.

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What market drivers drive TYBOST sales growth or decline?

Direct answer: Sales rise when cobicistat-containing boosted regimens expand in use or maintain share; they fall when patients migrate to non-cobicistat boosters, alternative dosing strategies, or fixed-dose combinations that reduce cobicistat’s separate use.

Demand drivers

• Guideline and regimen selection. HIV treatment guidance influences the preferred protease inhibitor backbone and booster choice.
• Clinical positioning vs. ritonavir boosters. Many payors and providers select between cobicistat and ritonavir based on tolerability, drug interaction burden, and regimen convenience.
• Drug interaction management. Cobicistat and ritonavir both are CYP3A modulators; prescribers may choose the booster that best fits an individual’s interaction profile and co-medications.

Supply and continuity drivers

• Manufacturing capacity and supply stability. Shortages or allocation can depress realized sales regardless of underlying demand.
• Adherence patterns affected by dosing schedule. Where cobicistat is part of a regimen that is simpler for patients, adherence can support persistence and refill rates.

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Which competitors pressure TYBOST, and how do they compare?

Direct answer: TYBOST faces indirect competition from (1) ritonavir-based boosters and (2) fixed-dose combinations that incorporate cobicistat (or reduce the need for separate booster prescribing), shifting share within the broader “boosted ART” segment.

Competitive set

• Ritonavir-boosted regimens (primary competitive substitute). Ritonavir is the standard reference booster in many ART combinations; switching boosters can occur via regimen change.
• Alternative boosting strategies and fixed-dose combinations. When cobicistat is embedded in combination products that simplify prescribing, it can either expand cobicistat exposure or change how it is billed and counted.

What this means for pricing power

Booster products typically have limited pricing power because:

• Demand is derived from regimen selection,
• PBM contracting can quickly neutralize list-price changes,
• Switching boosters can be operationally straightforward for certain protease inhibitor backbones.

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What does the payer and reimbursement landscape look like for TYBOST?

Direct answer: TYBOST commercial performance is highly sensitive to formulary placement and net price, with PBM and payer contracting shaping utilization more than marginal clinical advantages.

Typical payer dynamics

• Preferred booster inclusion. If cobicistat is a preferred booster for specific combination products, coverage can be stable.
• Prior authorization and step therapy. Some plans require documentation that supports booster selection, which can slow uptake.
• Rebate-driven economics. The net revenue trajectory depends on contract terms that often move with competitive pressure and volume expectations.

Commercial implication

Even in a stable patient pool, TYBOST revenue can shift due to:

• changes in formulary tiering,
• changes in rebate rates,
• changes in pharmacy channel mix.

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What are the financial trend patterns for TYBOST over time?

Direct answer: A booster product’s financial trajectory often shows a “persistence-driven” pattern: modest growth or stability during patient ramp-up, followed by slower growth as guideline-driven utilization matures, with step-down risk when competitive substitution or regimen migration increases.

Practical trend drivers that typically show up in financial results

• Mix shift within boosted HIV therapy. Revenue can trend with the relative mix of patients on darunavir-containing boosted regimens versus other backbones.
• Store-and-forward prescribing dynamics. When formulary decisions tighten, prescriptions can lag before switching, creating delayed declines.
• Net price pressure. Competitive contracts and volume-based rebates can compress revenue growth even with stable units.

What to monitor in filings

For a booster like TYBOST, investors and licensors typically track:

• prescription counts and new starts,
• persistence and refill rates (proxy via Rx trends),
• payer coverage changes and list price versus net price.

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When does TYBOST face exclusivity or generic entry risk, and how does it affect revenue?

Direct answer: Generic-entry risk is a key inflection point for small chronic-market products, but the real revenue impact depends on timing, patent/Exclusivity status, and whether generics enter as separate cobicistat tablets or substitute through regimen switching.

What drives revenue impact on entry

• Share loss speed. Chronic products can show relatively rapid unit share loss after generic launches, though net revenue can cushion via rebates and continued contracting.
• Substitution barriers. If prescribers and formularies strongly favor branded regimens or FDC alternatives, cobicistat generic impact can be slower.
• Switching costs within ART. Switching boosters can be clinically straightforward in stable patients, but it may be minimized by prescriber and patient preference, which slows total share transfer.

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How do Paragraph IV and ANDA challenges typically affect TYBOST’s financial outlook?

Direct answer: Paragraph IV filings can front-load uncertainty, often triggering settlement activity or slowing generic adoption through litigation stays, which temporarily protects revenue.

Market effects

• Settlement timelines influence “at risk” generic volume. If courts grant injunctions or settlements delay launch, revenue may remain protected beyond the first legal entry window.
• Timing uncertainty affects payer behavior. Payers may adjust formularies ahead of anticipated generic launch, altering branded unit share even before an actual generic product is on the market.

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What is the Orange Book status of TYBOST?

Direct answer: The ability to quantify Orange Book listings, listed patents, and expiration dates requires the Orange Book record for TYBOST. Without the product’s specific FDA list entry and associated patent numbers and expiration dates, a precise status cannot be stated.

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What patents protect TYBOST, and what does that mean for commercial risk?

Direct answer: Patent protection shape determines the probability and timing of generic and 505(b)(2) substitution, but a definitive mapping requires the identified TYBOST patent list and expiration dates.

Where patent estates matter in boosters

• Active ingredient and composition claims can block generic approval.
• Method-of-use claims are often less relevant for boosters because they are integrated into standard boosted ART use.
• Formulation and manufacturing claims can still constrain “authorized” entry dates if a generic needs a different process route.

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How does TYBOST compare with ritonavir-based boosters on market dynamics?

Direct answer: Cobicistat and ritonavir compete within boosted ART, and the market share outcome depends on regimen convenience and tolerability factors that drive prescriber preference and payer contracting.

Competitive substitution scenarios

• Ritonavir wins when formularies prefer it or when tolerance and interaction profiles align.
• Cobicistat wins when prescribing favors cobicistat-containing regimens or when fixed-dose convenience is optimized.

Financial effect

Even if total boosted ART patients are stable, the booster market can shift between suppliers. TYBOST revenue therefore depends on maintaining share in cobicistat-favored regimens.

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How are fixed-dose combinations changing TYBOST’s business economics?

Direct answer: Fixed-dose combinations can reduce the “separately dispensed” booster unit count and change how booster utilization is reflected in market data.

Economics shift

• Fewer distinct claims lines, different reporting granularity. Even when cobicistat is still used, it may appear within FDC utilization rather than as standalone TYBOST dispensing.
• Contracting structure changes. Brands embedded in FDCs can negotiate different rebates and pricing, shifting net revenue distribution.

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What regulatory events can affect TYBOST commercial trajectory?

Direct answer: For a booster product, the main regulatory events affecting commercial outcomes are changes in label, new indications or dosing instructions, safety communications affecting prescribing, and supply/packaging actions.

Regulatory pathways and downstream use

• New label expansions or updated guidance can shift regimen choice.
• Safety-related label updates can affect persistence if prescribers adjust co-medications or dosing.

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What are generic launch scenarios for TYBOST, and what revenue exposure do they create?

Direct answer: Generic exposure depends on (1) whether a generic enters as an approved equivalent for the same indication and (2) how quickly formularies and prescribers switch.

Typical launch scenarios

• Scenario A: Generic-only substitution. Rapid share loss if generic is preferred on formularies and therapeutically interchangeable.
• Scenario B: Partial substitution with continued branded dominance. Slower declines if physicians or payers maintain branded selection due to contracting or patient history.
• Scenario C: Regimen migration offsets the generic impact. If patients move to alternative FDCs or different backbones, branded cobicistat units can fall even without generic launch.

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Key takeaways

• TYBOST’s revenue is driven by downstream boosted HIV regimen selection, not independent market adoption.
• The largest commercial swing factors are payer contracting, formulary preference, and regimen migration within boosted ART.
• Competitive pressure is indirect: TYBOST’s main substitutes are ritonavir-based boosters and regimen-level fixed-dose choices.
• Generic entry risk is a key inflection point, but the timing and magnitude depend on Orange Book-listed patents/exclusivity and litigation-driven launch delays.
• Financial trajectory should be evaluated through persistent utilization metrics (Rx trends), net pricing dynamics, and formulary coverage shifts, not just list-price growth.

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FAQs

1) Does TYBOST face the same generic threat pattern as typical small-molecule chronic drugs?
Booster products often see generic threats, but revenue outcomes depend on regimen persistence, formulary switching speed, and FDC migration.

2) Are TYBOST sales mainly protected by clinical switching resistance?
Persistence exists, but booster demand is mostly regimen-driven; payer and prescriber behavior can still cause share movement.

3) How do fixed-dose combinations affect “TYBOST revenue” reporting?
They can shift cobicistat utilization into bundled products, changing observed standalone TYBOST unit counts.

4) What are the biggest financial drivers after generic launch for cobicistat?
Net price compression, rebate changes, and the speed of formulary preference shifts determine the revenue path.

5) Can safety communications change TYBOST prescribing patterns quickly?
Label changes and safety actions can alter co-medication decisions and persistence, impacting refill rates even if efficacy remains unchanged.

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References (APA)

No sources were cited because the required FDA Orange Book entry, patent listings, FDA milestones, and financial/regional utilization metrics for TYBOST were not provided in the input.