TYVASO Drug Patent Profile

Which patents cover Tyvaso, and what generic alternatives are available?

Tyvaso is a drug marketed by United Therap and is included in two NDAs. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-five patent family members in nine countries.

The generic ingredient in TYVASO is treprostinil. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tyvaso

A generic version of TYVASO was approved as treprostinil by SANDOZ on November 30^th, 2017.

Summary for TYVASO

International Patents:	35
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	23
Patent Applications:	1,367
Drug Prices:	Drug price information for TYVASO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYVASO
What excipients (inactive ingredients) are in TYVASO?	TYVASO excipients list
DailyMed Link:	TYVASO at DailyMed

See drug prices for TYVASO

Recent Clinical Trials for TYVASO

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

Sponsor	Phase
United Therapeutics	Phase 1
Bastiaan Driehuys	Phase 2
Children's Hospital Medical Center, Cincinnati	Phase 2

See all TYVASO clinical trials

Pharmacology for TYVASO

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for TYVASO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TYVASO	Inhalation Solution	treprostinil	0.6 mg/mL, 2.9 mL ampules	022387	1	2015-04-13

US Patents and Regulatory Information for TYVASO

TYVASO is protected by six 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
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022		RX	Yes	Yes
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022		RX	Yes	No			Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022		RX	Yes	Yes				Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022		RX	Yes	No				Y
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009		RX	Yes	Yes
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-002	May 23, 2022		RX	Yes	No			Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022		RX	Yes	No

Expired US Patents for TYVASO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009

EU/EMA Drug Approvals for TYVASO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
SciPharm Sàrl	Trepulmix	treprostinil	EMEA/H/C/005207 Treatment of adult patients with WHO Functional Class (FC) III or IV and:inoperable chronic thromboembolic pulmonary hypertension (CTEPH), orpersistent or recurrent CTEPH after surgical treatmentto improve exercise capacity.	Authorised	no	no	yes	2020-04-03

International Patents for TYVASO

See the table below for patents covering TYVASO around the world.

Country	Patent Number	Title	Estimated Expiration
China	1264819
World Intellectual Property Organization (WIPO)	2007134292
European Patent Office	1161234	TRAITEMENT DE L'HYPERTENSION PULMONAIRE PAR INHALATION DE BENZINDENE-PROSTAGLANDINES (TREATMENT OF PULMONARY HYPERTENSION BY INHALATION OF BENZINDENE PROSTAGLANDINS)
Spain	2045437
Germany	68904358
European Patent Office	0347243	PROSTAGLANDIN ANALOGUES FOR USE IN MEDICINE
China	1283184

TYVASO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TYVASO

Introduction to TYVASO

TYVASO, developed by United Therapeutics, is an inhaled formulation of treprostinil, a prostacyclin analogue used primarily to treat Pulmonary Arterial Hypertension (PAH) and other related conditions. Here, we delve into the market dynamics and financial trajectory of TYVASO, highlighting its current status, future prospects, and the competitive landscape.

Mechanism of Action and Clinical Use

TYVASO works by dilating systemic and pulmonary arterial vascular beds, thereby reducing pulmonary vascular resistance. It is administered via inhalation, which is generally better tolerated compared to continuous subcutaneous or intravenous administration of other prostacyclins like Remodulin[4].

Market Performance

Revenue Growth

TYVASO has shown significant revenue growth in recent years. In the third quarter of 2024, TYVASO revenues grew by 33% to $433.8 million, contributing substantially to United Therapeutics' total revenues of $748.9 million, which itself saw a 23% year-over-year increase[2].

Historical Sales Data

Historical data indicates that TYVASO has maintained a strong sales trajectory. From 2016 to 2023, TYVASO sales in the US have consistently increased, with forecasts suggesting continued growth up to 2032[1][4].

Regulatory Milestones and Development Activities

Clinical Trials and Studies

The INCREASE study, a phase III clinical trial, demonstrated the efficacy of TYVASO in patients with interstitial lung disease, meeting both primary and secondary endpoints. This study is expected to support an efficacy supplement to the U.S. Food and Drug Administration, potentially expanding TYVASO's labeling and market opportunity[3].

Regulatory Environment

TYVASO has achieved several regulatory milestones, including approvals for its use in PAH and other pulmonary hypertension-associated conditions. The drug's regulatory status is closely monitored, with ongoing activities aimed at expanding its indications and maintaining its market position[1].

Competitive Landscape

Emerging Therapies

The PAH market is witnessing the emergence of new therapies that could challenge TYVASO's dominance. Products like Uptravi (selexipag) and Orenitram (oral treprostinil) from Johnson & Johnson/Nippon Shinyaku and United Therapeutics, respectively, offer alternative treatment options. Additionally, LIQ861 (treprostinil dry powder for inhalation) from Liquidia Technologies is in Phase III trials and could further compete with TYVASO[4].

Market Competition

Despite these challenges, United Therapeutics is positioning TYVASO for potential label expansion in pulmonary hypertension associated with lung disease (PH-LD), which could help revive sales growth and mitigate competition from newer therapies[4].

Financial Highlights

Revenue Components

TYVASO is a significant contributor to United Therapeutics' total revenues. In the third quarter of 2024, TYVASO revenues accounted for approximately 58% of the company's total net product sales[2].

Operating Expenses and Income

United Therapeutics' operating expenses, including cost of sales, research and development, and selling, general, and administrative expenses, have been managed effectively to support the growth of TYVASO. The company reported an operating income of $343.1 million in the third quarter of 2024, with net income increasing by 16% to $309.1 million[2].

Forecasted Sales and Market Projections

Market Growth Projections

The PAH market is expected to expand due to extensive research and increased healthcare spending globally. This growth is anticipated to benefit TYVASO, with forecasted sales expected to continue rising up to 2032. The report from Research and Markets provides a detailed analysis of the forecasted sales data, supporting decision-making processes for therapeutic portfolios[1].

Late-Stage Emerging Therapies

The launch of late-stage emerging therapies in the near future is expected to significantly impact the market. However, TYVASO's established presence and potential label expansions are likely to help it maintain a competitive edge[1].

SWOT Analysis

Strengths

• Established Market Presence: TYVASO has a well-established market niche in the PAH treatment landscape.
• Clinical Efficacy: Strong clinical trial data, such as the INCREASE study, supports its efficacy.
• Patient Preference: The inhaled formulation is generally better tolerated than other administration methods.

Weaknesses

• Competition from New Therapies: Emerging oral and other inhalation therapies pose a significant competitive threat.
• Geographical Limitations: Currently available only in the US, limiting global market reach.

Opportunities

• Label Expansion: Potential for label expansion in PH-LD and other conditions.
• Growing PAH Market: Increasing healthcare spending and research in PAH could expand the market size.

Threats

• Competitive Products: Newer, more convenient therapies like Uptravi and Orenitram.
• Regulatory Changes: Changes in regulatory environments could impact TYVASO's market position.

Analyst Outlook

Analysts view TYVASO as a key product in United Therapeutics' portfolio, with significant potential for continued growth despite the competitive landscape. The drug's unique formulation and strong clinical data are seen as key factors in its market success[4].

Key Takeaways

• Revenue Growth: TYVASO has shown substantial revenue growth, contributing significantly to United Therapeutics' total revenues.
• Clinical Efficacy: Strong clinical trial data supports TYVASO's efficacy in PAH and other conditions.
• Competitive Landscape: Emerging therapies pose a challenge, but potential label expansions could help maintain market position.
• Market Projections: Forecasted sales are expected to continue rising up to 2032, driven by market growth and healthcare spending.

FAQs

Q: What is TYVASO used for?

TYVASO is used primarily to treat Pulmonary Arterial Hypertension (PAH) and other related conditions.

Q: How is TYVASO administered?

TYVASO is administered via inhalation, which is generally better tolerated than continuous subcutaneous or intravenous administration.

Q: What were the results of the INCREASE study?

The INCREASE study demonstrated the efficacy of TYVASO in patients with interstitial lung disease, meeting both primary and secondary endpoints.

Q: What are the main competitors to TYVASO in the PAH market?

Key competitors include Uptravi (selexipag), Orenitram (oral treprostinil), and LIQ861 (treprostinil dry powder for inhalation).

Q: What are the forecasted sales projections for TYVASO up to 2032?

Forecasted sales of TYVASO are expected to continue rising up to 2032, driven by market growth and increased healthcare spending.

Sources

1. Research and Markets: TYVASO Drug Insight and Market Forecast.
2. Stock Titan: United Therapeutics Corporation Reports Third Quarter 2024 Financial Results.
3. PR Newswire: United Therapeutics Announces INCREASE Study Of Tyvaso Meets Primary And All Secondary Endpoints.
4. Business Wire: Tyvaso (treprostinil) Drug Overview & Product Profile 2019.
5. Business Wire: United Therapeutics Corporation Reports Second Quarter 2023 Financial Results.