TYVASO DPI Drug Patent Profile

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

Tyvaso Dpi is a drug marketed by United Therap and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and forty-four patent family members in twenty countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tyvaso Dpi

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

Summary for TYVASO DPI

International Patents:	144
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	26
Patent Applications:	1,657
Drug Prices:	Drug price information for TYVASO DPI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYVASO DPI
What excipients (inactive ingredients) are in TYVASO DPI?	TYVASO DPI excipients list
DailyMed Link:	TYVASO DPI at DailyMed

See drug prices for TYVASO DPI

Recent Clinical Trials for TYVASO DPI

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

Sponsor	Phase
University of California, San Diego	EARLY_PHASE1
United Therapeutics	EARLY_PHASE1
Yuh Chin T Huang, MD, MHS	PHASE1

See all TYVASO DPI clinical trials

Pharmacology for TYVASO DPI

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

US Patents and Regulatory Information for TYVASO DPI

TYVASO DPI is protected by seven 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	214324-004	May 23, 2022		RX	Yes	Yes			Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-005	Oct 24, 2024		RX	Yes	Yes
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022		RX	Yes	Yes				Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-001	May 23, 2022		RX	Yes	Yes
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022		RX	Yes	Yes
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022		RX	Yes	Yes

Expired US Patents for TYVASO DPI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-005	Oct 24, 2024
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-002	May 23, 2022
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-001	May 23, 2022

EU/EMA Drug Approvals for TYVASO DPI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
SciPharm Sàrl	Trepulmix	treprostinil	EMEA/H/C/005207Treatment 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 DPI

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20180079458
South Korea	20150128984
Argentina	077086
South Korea	101644250
South Korea	102246914
South Korea	101875969
Russian Federation	2012100715

Market Dynamics and Financial Trajectory for TYVASO DPI

Last updated: July 27, 2025

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Introduction

TYVASO DPI (treprostinil diolamine) is an inhaled prostacyclin analog developed by United Therapeutics Corporation for the treatment of pulmonary arterial hypertension (PAH). Approved by the FDA in 2020, TYVASO DPI offers a dry powder inhalation alternative to the existing liquid formulations, aiming to improve patient compliance and convenience. As a high-cost specialized therapy, its market dynamics are shaped by competitive, regulatory, and clinical factors influencing its financial trajectory. This report examines these factors critically, assessing the potential growth, market share drivers, and risks associated with TYVASO DPI within the broader PAH treatment landscape.

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Market Overview and Demand Drivers

Global Pulmonary Arterial Hypertension Market

The PAH market has witnessed significant growth over the past decade, driven by increased diagnosis rates, expanded therapeutic options, and advances in targeted therapies. The global PAH market was valued at approximately USD 4 billion in 2022, with expectations to grow at a CAGR of 7.5% through 2030 (1).

Patient Population and Market Penetration

The prevalence of PAH is estimated at 15-50 cases per million, predominantly affecting young adults and women (2). Although relatively small, the U.S. accounts for a substantial share owing to advanced healthcare infrastructure and regulatory approval for innovative drugs like TYVASO DPI.

Clinical Positioning

TYVASO DPI offers an alternative to treprostinil IV and subcutaneous formulations, with potential benefits including reduced infusion-site complications and enhanced patient mobility. It targets a niche of patients requiring continuous prostacyclin therapy who prefer inhalation over invasive methods (3).

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Market Dynamics

Competitive Landscape

The PAH treatment regimens comprise endothelin receptor antagonists (ERAs), phosphodiesterase-5 inhibitors (PDE5 inhibitors), prostacyclin analogs, and soluble guanylate cyclase stimulators.

• Key competitors:
  • Remodulin (treprostinil inhalation, subcutaneous, IV)
  • Ventavis (iloprost inhalation)
  • Uptravi (selexipag)
  • Adempas (riociguat)

TYVASO DPI’s unique positioning as a dry powder inhalation reduces competition from liquid-based inhalers like Ventavis. However, it competes with other inhaled therapies and systemic prostacyclin options.

Regulatory and Reimbursement Environment

Regulatory approval from the FDA in 2020 facilitated market entry, but reimbursement strategies significantly impact adoption. High drug costs necessitate robust payer negotiations; the drug’s value proposition hinges on improved compliance and reduced hospitalization costs associated with PAH management (4).

Pricing Strategy

United Therapeutics has positioned TYVASO DPI at a premium, reflecting its innovative delivery and clinical benefits. The average annual treatment cost exceeds USD 150,000, aligning with other prostacyclin therapies. Pricing remains sensitive to payer approval and generic competition, should biosimilars emerge.

Market Penetration and Adoption

Initial adoption rates were modest due to cautious clinician acceptance, largely influenced by the drug’s novelty and reimbursement hurdles. However, early clinical data showing improved tolerability and patient comfort have begun to accelerate prescriptions.

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Financial Trajectory

Revenue Projections

Considering the small but expanding patient population, the revenue potential for TYVASO DPI depends on:

• Market share gains within PAH therapy: Estimated to capture 10-15% of the prostacyclin segment by 2025 (5).
• Patient accessibility and adherence: Inhaled delivery potentially boosts adherence, translating into sustained revenue.
• Pricing and reimbursement adjustments: Competitive pressures may influence net pricing.

Forecasts:

• 2023: Estimated USD 50-80 million in sales, driven by early adoption and demographic coverage.
• 2025: Potential to reach USD 150-200 million, assuming increased clinician familiarity and expansion into international markets.
• 2030: Sales could surpass USD 300 million if market expansion, patent protections, and pharmacoeconomic advantages materialize.

Cost Structure and Profitability

United Therapeutics invests heavily in clinical trials and sales infrastructure for TYVASO DPI. Marginal profitability depends on economies of scale in manufacturing dry powder formulations and price negotiations. The high fixed costs necessitate substantial revenue volumes for sustainable profit margins.

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Market Risks and Opportunities

Risks

• Competitive threats: Entry of biosimilars or innovative oral therapies could diminish the market share.
• Regulatory and reimbursement hurdles: Inconsistent payer coverage may limit adoption.
• Clinical acceptance: Slow clinician adoption if long-term benefits over existing therapies are unproven or unclear.

Opportunities

• Expanding indications: Exploring TYVASO DPI for other pulmonary hypertensive disorders or pulmonary fibrosis.
• Global expansion: Increasing presence in Europe, Asia, and emerging markets with high PAH prevalence.
• Technological improvements: Enhancing inhaler design for better delivery efficiency and patient usability.

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Strategic Implications

Market success for TYVASO DPI hinges on demonstrating clear clinical advantages, securing favorable reimbursement, and expanding beyond early adopters. Partnerships with healthcare providers and patient advocacy groups can facilitate adoption. Moreover, leveraging pharmacoeconomic data to justify premium pricing will be central to maximizing revenue.

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Key Takeaways

• Market Size and Growth: The PAH market remains modest but expanding, with TYVASO DPI poised to capture a niche segment through innovation and patient-centric delivery.
• Revenue Potential: Sales are projected to grow substantially over the next decade, with revenues possibly reaching USD 300 million by 2030, contingent upon market penetration and reimbursement landscape.
• Competitive Position: Distinctive dry powder inhalation differentiates TYVASO DPI but faces competition from established therapies and future biosimilar entries.
• Pricing and Reimbursement: High treatment costs require strategic payer negotiations; value demonstration through improved compliance and reduced hospitalization will be pivotal.
• Strategic Focus: Expansion into global markets, indication diversification, and technological enhancements will reinforce long-term financial prospects.

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FAQs

1. How does TYVASO DPI compare clinically to other prostacyclin therapies?
TYVASO DPI offers a non-invasive, inhaled delivery method with potential benefits in adherence and convenience. Clinical trials demonstrate comparable efficacy to liquid formulations, with improved tolerability and fewer infusion-site adverse events. However, long-term comparative studies are ongoing to fully establish its clinical superiority.

2. What is the main barrier to broader adoption of TYVASO DPI?
Reimbursement complexities and clinician familiarity remain significant barriers. High treatment costs and limited long-term real-world data can slow uptake among prescribing physicians.

3. Can TYVASO DPI impact the overall PAH market size?
While it targets a niche within the PAH therapy spectrum, its success can influence the broader market by setting new standards for inhaled prostacyclin delivery and patient quality of life.

4. What are the key growth opportunities for United Therapeutics regarding TYVASO DPI?
International expansion, new indications, and technological advances in inhaler design present significant opportunities to grow its market footprint.

5. How might biosimilar competition influence TYVASO DPI’s market share?
The emergence of biosimilars could pressure pricing and diminish profit margins, but current patent protections and focus on differentiated delivery may mitigate immediate risks.

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Sources

1. Market Research Future, 2022
2. Pulmonary Hypertension Association, 2021
3. United Therapeutics Clinical Data, 2022
4. IQVIA Healthcare Data, 2022
5. Evaluate Pharma, 2022