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 two 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:	302
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	6
Patent Applications:	601
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	203094-001	Sep 24, 2014		RX	Yes	Yes	8,148,374*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	203094-001	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/002572 Tybost 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
Japan	5554300
New Zealand	594214	TABLETS COMPRISING COBICISTAT, ELVITEGRAVIR, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE FOR COMBINATION THERAPY
South Korea	101659971
Spain	2603645
Taiwan	201040142	Tablets for combination therapy

Supplementary Protection Certificates for TYBOST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	18/2020	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT, UND EMTRICITABIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170925
2487166	2016/061	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
3150586	301045	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER DARUNAVIRETHANOLAAT, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1225 20170925
2487162	PA2016040,C2487162	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS IR DARUNAVIRAS,ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119

Market Dynamics and Financial Trajectory for TYBOST

Introduction to TYBOST

TYBOST, also known as cobicistat, is a CYP3A inhibitor used in combination with other antiretroviral agents to treat HIV-1 infection in adults and pediatric patients. It is manufactured by Gilead Sciences and plays a crucial role in the HIV treatment regimen by increasing the systemic exposure of atazanavir or darunavir.

Indications and Usage

TYBOST is indicated for use in combination with atazanavir or darunavir, once daily, to treat HIV-1 infection. It is used in both adult and pediatric patients, with specific weight requirements for pediatric use[4].

Market Positioning

TYBOST is part of Gilead Sciences' extensive HIV treatment portfolio, which includes other prominent drugs like Biktarvy, Descovy, and Truvada. The HIV market is highly competitive, but Gilead's products have maintained a strong presence due to their efficacy and market acceptance.

Financial Performance of Gilead Sciences' HIV Portfolio

In the full year 2023, Gilead Sciences' HIV product sales increased by 6% year-over-year (YoY) to $18.2 billion, driven by higher demand and favorable channel inventory dynamics. This growth was largely attributed to the performance of Biktarvy and Descovy, which are often used in conjunction with TYBOST[1].

Biktarvy and Descovy Sales

• Biktarvy sales increased by 14% YoY to $11.8 billion in 2023, reflecting higher demand and higher average realized prices.
• Descovy sales increased by 6% YoY to $2.0 billion in 2023, driven by favorable channel inventory dynamics and higher demand[1].

TYBOST Sales Integration

While specific sales figures for TYBOST are not separately reported, its contribution is integral to the overall HIV product sales. TYBOST is often co-administered with other antiretroviral agents like atazanavir and darunavir, which are part of the broader HIV treatment regimen.

Market Trends and Demand

The HIV treatment market has seen consistent growth driven by increasing demand for antiretroviral therapies (ART) and pre-exposure prophylaxis (PrEP). Gilead Sciences has maintained a strong market share in the U.S. and globally, with its HIV products commanding a significant portion of the market.

U.S. Market Share

Gilead Sciences' U.S. market share for HIV treatments remained robust, with a market share of approximately 48% in 2023. The company also saw a 3% YoY growth in U.S. market share[3].

Pricing Dynamics

Pricing dynamics play a crucial role in the sales performance of TYBOST and other HIV drugs. In the fourth quarter of 2023, HIV product sales were affected by lower average realized prices due to channel mix, although this was partially offset by higher demand and favorable inventory dynamics[1].

Competitive Landscape

The HIV treatment market is highly competitive, with several pharmaceutical companies offering various antiretroviral therapies. However, Gilead Sciences' portfolio, including TYBOST, has maintained a strong competitive edge due to its efficacy, safety profile, and established market presence.

Regulatory and Safety Considerations

TYBOST, like other antiretroviral agents, is subject to regulatory oversight and safety monitoring. It has been associated with renal adverse events, particularly when co-administered with tenofovir disoproxil fumarate (TDF), and requires careful monitoring of renal function in patients[2][4].

Future Outlook

The future outlook for TYBOST and Gilead Sciences' HIV portfolio remains positive, driven by ongoing demand for effective HIV treatments and the company's continued innovation in the field. However, the market will continue to be influenced by factors such as pricing dynamics, regulatory changes, and the introduction of new therapies.

Growth Projections

Gilead Sciences anticipates continued growth in its HIV business, with a focus on maintaining market leadership through strong demand for its products and strategic partnerships. The company's overall product sales, excluding Veklury, increased by 7% in 2023, and this trend is expected to continue in the coming years[1].

Key Takeaways

• TYBOST is a critical component of Gilead Sciences' HIV treatment portfolio.
• The drug's sales are integrated within the broader HIV product sales, which saw a 6% YoY increase in 2023.
• Pricing dynamics and channel mix can impact sales, but overall demand for HIV treatments remains strong.
• Regulatory and safety considerations are crucial for the continued use of TYBOST.
• The future outlook for TYBOST and Gilead's HIV portfolio is positive, driven by ongoing demand and innovation.

FAQs

1. What is TYBOST used for?

TYBOST is used as a CYP3A inhibitor to increase the systemic exposure of atazanavir or darunavir in the treatment of HIV-1 infection in adults and pediatric patients[4].

2. How does TYBOST contribute to Gilead Sciences' financial performance?

TYBOST contributes to Gilead Sciences' financial performance as part of the company's broader HIV treatment portfolio, which saw a 6% YoY increase in sales in 2023[1].

3. What are the potential side effects of TYBOST?

TYBOST can cause renal adverse events, particularly when co-administered with TDF, and may lead to increases in serum creatinine and decreases in estimated creatinine clearance[2][4].

4. How does the competitive landscape affect TYBOST sales?

The competitive landscape in the HIV treatment market is highly competitive, but Gilead Sciences' portfolio, including TYBOST, maintains a strong competitive edge due to its efficacy and established market presence.

5. What is the future outlook for TYBOST and Gilead Sciences' HIV portfolio?

The future outlook is positive, driven by ongoing demand for effective HIV treatments and Gilead Sciences' continued innovation in the field. The company anticipates continued growth in its HIV business[1].

Cited Sources:

1. Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results - Gilead Sciences
2. TYBOST® (cobicistat) tablets, for oral use - Gilead Sciences
3. Q4 & FY23 Financial Results - Gilead Sciences
4. Tybost: Package Insert / Prescribing Information - Drugs.com