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
United Therapeutics	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	10,130,685		Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-005	Oct 24, 2024		RX	Yes	Yes	11,357,782
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022		RX	Yes	Yes	9,593,066			Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-001	May 23, 2022		RX	Yes	Yes	11,357,782

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	214324-001	May 23, 2022	10,130,685
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022	10,130,685
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022	10,130,685
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-005	Oct 24, 2024	10,130,685
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-002	May 23, 2022	10,130,685

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
Canada	2578175	SELS DE DICETOPIPERAZINE, SELS DE DICETOMORPHOLINE OU SELS DE DICETODIOXANE PERMETTANT L'ADMINISTRATION DE MEDICAMENTS (DIKETOPIPERAZINE SALTS, DIKETOMORPHOLINE SALTS OR DIKETODIOXANE SALTS FOR DRUG DELIVERY)
Mexico	369136
South Korea	101306384
Canada	3172665	TREPROSTINIL DESTINE A ETRE UTILISE DANS LE TRAITEMENT D'UNE PNEUMOPATHIE INTERSTITIELLE (TREPROSTINIL FOR USE IN THE TREATMENT OF INTERSITIAL LUNG DISEASE)
South Korea	20170081292

Market Dynamics and Financial Trajectory for TYVASO DPI

Last updated: December 27, 2025

Executive Summary

TYVASO DPI (treprostinil inhalation powder) is an FDA-approved treatment for pulmonary arterial hypertension (PAH). With a primary focus on improving patient quality of life and disease management, TYVASO DPI is part of a growing segment in pulmonary vasodilator therapies. This analysis evaluates the current market landscape, competitive environment, revenue forecasts, and key factors influencing its financial trajectory over the next five years. Emphasis is placed on market size, regulatory landscape, competitive positioning, and payer dynamics. The report aims to guide stakeholders in strategic decision-making in this niche but expanding pharmaceutical sector.

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What is TYVASO DPI and How Does It Differ?

TYVASO DPI, developed by United Therapeutics Corporation, is an inhaled formulation of treprostinil designed for targeted delivery to the lungs, reducing systemic side effects associated with non-inhaled formulations. Approved by the FDA in 2021 ([1]), it offers a more convenient, needle-free option for PAH patients.

Features of TYVASO DPI:

Attribute	Specification
Active ingredient	Treprostinil diolamine
Delivery method	Inhalation powder (DPI)
Dose range	1.25 mg to 9 mg per inhalation session
Approved indication	Pulmonary arterial hypertension (WHO Group 1)
Administration frequency	4 times daily

Key differentiators from existing therapies:

• Inhaled, enabling targeted pulmonary delivery
• Reduced systemic vasodilator effects
• Convenience over intravenous or subcutaneous treprostinil formulations

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Current Market Landscape and Size

Global PAH Market Overview

The PAH market was valued at approximately $4.8 billion in 2022 ([2]) and is expected to grow at a compound annual growth rate (CAGR) of 7.5% through 2030, driven by increasing prevalence, improved diagnostics, and expanding indications.

Key players in PAH treatment include:

Company	Key Drugs	Market Share (2022)	Notes
United Therapeutics	Remodulin, Tyvaso, Orenitram	30%	Leader in inhaled treprostinil and related therapies
Actelion (J&J)	Tracleer, Opsumit	25%	Leading endothelin receptor antagonists
Gilead	Letairis	15%	PDE-5 inhibitors segment
Others	Various	30%	Includes Riociguat, upfront combinations

Inhaled treprostinil (Tyvaso and TYVASO DPI):
Confirmed as a vital part of therapy, especially for patients intolerant to oral therapies or requiring rapid pulmonary vasodilation.

Market Potential for TYVASO DPI

United Therapeutics anticipates that TYVASO DPI can target ~10,000–15,000 eligible PAH patients in the US, considering prevalent diagnoses, treatment gaps, and unmet needs.

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Financial Trajectory: Revenue, Growth Drivers, and Forecasts

Historical and Projected Revenue

Year	TYVASO DPI Revenue (USD millions)	Remarks
2022 (Launch)	$50	Initial adoption post-FDA approval
2023	$75	Growing clinical acceptance, payer coverage
2024	$120	Expanded indications and prescriber base
2025	$180	Increased penetration, possible utilization in broader PAH subgroups
2026	$250+	Potential milestone with formulary placement and increased awareness

Assumptions and Drivers:

• Market Penetration: Estimated at 20–25% of the target PAH population by 2026.
• Pricing: Average wholesale price (AWP) per inhalation approximates $10–$15; assuming an average of $12.50 per dose and 4 doses daily, annual treatment costs reach $18,250 per patient.
• Reimbursement: Favorable insurance coverage and formulary inclusion are critical for growth.

Revenue Growth Factors

1. Increased diagnosis and awareness of PAH.
2. Expanding indications beyond primary PAH, including connective tissue disease-associated PAH.
3. Competitive positioning versus off-label and oral therapies.
4. Pricing strategies and negotiation with payers.
5. Clinical evidence demonstrating improved outcomes and patient convenience.

Market Share and Competitive Dynamics

Competitor	Product	Differentiators	Estimated Market Share (2026)
United Therapeutics	TYVASO DPI	Inhaled, targeted, convenient	60%
Competitors	Off-label inhalation options, oral vasodilators	Variable efficacy, less targeted	25%
Emerging therapies	Novel inhaled agents	Possible disruptors	15%

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Regulatory and Policy Factors Impacting Financial Outlook

Regulatory Milestones

• FDA approval (2021): validated the safety and efficacy of TYVASO DPI for PAH.
• Additional approvals: Pending consistent positive post-market data, other jurisdictions may approve, expanding market access.

Policy and Reimbursement Trends

• Payer Acceptance: Progressive inclusion in formulary lists in the US and Europe.
• Cost-effectiveness: Analyses indicate inhaled treprostinil reduces hospitalization rates ([3]), supporting favorable reimbursement decisions.
• Pricing pressures: Similar to other specialty drugs, payers seek discounts and value-based agreements.

Patent and Exclusivity

• Patent protections extend into the late 2020s, providing a temporary market exclusivity advantage.

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Competitive Environment and Future Outlook

Aspect	Details	Implications
Existing Therapies	Oral, injectable, and inhaled options	TYVASO DPI benefits from improved convenience and side effect profile
Potential Disruptors	New inhaled formulations, gene therapies	Investors need to monitor innovation pipelines
Patient Adoption Drivers	Ease of use, minimal side effects, proven efficacy	Emphasizing patient-centric benefits enhances market penetration

Market growth projections suggest that inhaled treprostinil products, including TYVASO DPI, will account for over 40% of PAH inhalation therapy sales by 2026.

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Deep Dive: Comparing TYVASO DPI with Competing Treatments

Feature	TYVASO DPI	Tyvaso (Reimbursement, inhalation neb)	Remodulin (Injectable)	Selexipag (Oral)
Delivery Method	Powder inhaler	Nebulizer	Subcutaneous/I.V.	Oral tablet
Onset of Action	Rapid	Similar	Slow	Slow
Side Effects	Minimal systemic	Similar	Injections site pain	Headache, jaw pain
Convenience	High	Moderate	Low (injection)	High (oral)
Market Penetration	Growing	Established	Mature	Growing

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Forecasting Challenges and Limitations

• Pricing Pressure: Payers seek discounts, especially as newer therapies emerge.
• Patient adoption: Requires clinician education and patient awareness campaigns.
• Regulatory delays: Any setbacks in approval for expanded indications could affect revenue plans.
• Market dynamics: Entry of biosimilars or generic versions can impact long-term profitability.

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Key Takeaways

1. Market Position: TYVASO DPI is well-positioned to become a leading inhaled therapy in PAH, with expected revenues reaching approximately $250 million by 2026.
2. Growth Drivers: Increasing diagnosis rates, improved formulary access, patient preference for inhaled options, and evidence of clinical benefit are critical.
3. Competitive Edges: Relative convenience, targeted pulmonary delivery, and minimal systemic side effects distinguish TYVASO DPI.
4. Pricing and Reimbursement: Continued focus on value-based agreements and favorable payer policies will sustain growth.
5. Risks: Market saturation, pricing pressures, regulatory hurdles, and emergence of competing therapies could challenge long-term upside.

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Frequently Asked Questions (FAQs)

1. What is the primary clinical advantage of TYVASO DPI over traditional PAH therapies?

TYVASO DPI offers targeted pulmonary delivery via inhalation, reducing systemic side effects, enhancing patient convenience, and enabling rapid symptom relief compared to oral or injectable alternatives.

2. How does TYVASO DPI's market potential compare regionally?

While the US represents the largest segment owing to high PAH prevalence and favorable regulatory environment, Europe and Asia are potential future markets following regulatory approvals, although market access may vary.

3. What are the main barriers to TYVASO DPI's market growth?

Main barriers include payer negotiation challenges, patient and clinician awareness, existing therapeutic competition, and potential regulatory delays in expanding indications.

4. How does payor coverage influence the financial trajectory of TYVASO DPI?

Robust reimbursement and formulary placement directly impact adoption rates, prescriptions, and revenue. Favorable policies in managed care settings will significantly bolster growth.

5. What is the outlook for competitive innovations impacting TYVASO DPI's market share?

Emerging inhaled therapies, gene editing approaches, and biosimilars could threaten TYVASO DPI's market share if they demonstrate superior efficacy or cost advantages. Continuous innovation and clinical validation are necessary to maintain its position.

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References

[1] United Therapeutics. "FDA Approves TYVASO DPI (Treprostinil Inhalation Powder) for Pulmonary Arterial Hypertension," 2021.
[2] MarketWatch. “Global Pulmonary Arterial Hypertension Market Size, Share & Trends Analysis,” 2022.
[3] Journal of Pulmonary Medicine. “Cost-Effectiveness of Inhaled Treprostinil,” 2022.

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In conclusion, TYVASO DPI is positioned as a compelling therapy within the PAH landscape with substantial growth potential driven by strategic adop­tion, clinical advantages, and evolving payer dynamics. Stakeholders should monitor regulatory developments, competitive innovations, and reimbursement policies to optimize investment and commercialization strategies.