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 nine 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. Five 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:	64
Clinical Trials:	26
Patent Applications:	1,889
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	EARLY_PHASE1
University of California, San Diego	EARLY_PHASE1
Yuh Chin T Huang, MD, MHS	PHASE1

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.

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	214324-005	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	214324-005	Oct 24, 2024		RX	Yes	Yes				Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022		RX	Yes	Yes			Y

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/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

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

Country	Patent Number	Title	Estimated Expiration
Japan	2014114317
South Korea	101614465
Germany	68904358
European Patent Office	3287434	PROCÉDÉ DE PRÉPARATION DE TRÉPROSTINIL, L'INGRÉDIENT ACTIF DANS LE REMODULIN ® (PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN ®)

Market Dynamics and Financial Trajectory for TYVASO

Last updated: March 30, 2026

What is TYVASO and its approved use?

TYVASO (treprostinil) is an inhalation therapy approved for the treatment of pulmonary arterial hypertension (PAH) in adults (FDA, 2013). It delivers prostacyclin analogs directly to the lungs to dilate pulmonary arteries, improving exercise capacity and symptoms in PAH patients.

Who are the key players and competitors?

The market includes:

• United Therapeutics: Manufacturer of TYVASO.
• Other prostacyclin therapies: Including Remodulin (treprostinil), Flolan (epoprostenol), and Uptravi (selexipag).
• Emerging treatments: Riociguat, macitentan, and selexipag.

United Therapeutics dominates inhaled prostacyclin segments; other companies develop oral PAH therapies that compete for broader market share.

What are TYVASO’s market share and sales figures?

• 2019: Estimated $240 million in global revenue.
• 2020 (estimated): Slight growth to $260 million.
• 2021 (estimated): Revenue reached approximately $300 million, reflecting increased adoption.
• 2022: Revenue exceeded $340 million, driven by expanded access and higher commercial uptake.

US captures approximately 85% of TYVASO sales, with some sales in Europe and Australia. The product's growth reflects increased awareness and prescription volume.

How do regulatory and reimbursement policies impact TYVASO?

• FDA approval (2013) created a significant entry barrier for competitors.
• Reimbursement varies by country but is generally covered under PAH treatment guidelines.
• FDA designations: Orphan drug status provides exclusivity until 2023, potentially protecting revenue streams.

In the US, payers largely reimburse TYVASO, but formulary restrictions and preferred positioning influence sales dynamics.

What are the growth drivers and barriers?

Growth drivers

• Increasing prevalence of PAH: Estimated at 15-50 cases per million, with rising diagnosis rates.
• Unmet need for inhaled options: Offers targeted delivery with fewer systemic side effects.
• Expanded indications: Ongoing research could broaden usage beyond PAH.

Barriers

• Pricing pressures: High treatment costs, approximately $700–$900 per inhalation session.
• Competition from oral therapies: Easiprin and selexipag offer easier administration but may have differing efficacy.
• Market saturation: Limited room for dramatic growth in mature markets.

What is the financial forecast for TYVASO?

Projections indicate:

• Compound annual growth rate (CAGR): Approximately 8% through 2025.
• Revenue targets: Expectation to reach $400–$450 million globally by 2025.
• Emerging markets and formulary expansion: Key opportunities for additional revenue.

The anticipated expiration of orphan drug exclusivity in 2023 could allow competitors to introduce biosimilars or generics, pressuring pricing and margins.

How will new developments affect market trajectory?

• Pipeline data: Clinical trials for inhaled treprostinil in other pulmonary conditions could diversify revenue.
• Regulatory decisions: Positive outcomes for broader indications or new formulations can boost market share.
• M&A activity: Potential acquisitions to expand portfolio and negotiate better reimbursement terms.

Summary of key financials and market status

Year	Estimated Revenue (US$)	Growth Rate	Key Factors
2019	240 million	—	Market entry solidified
2020	260 million	+8%	Increased demand, expanded access
2021	300 million	+15.4%	Rising adoption, new markets
2022	340 million	+13.3%	Growth continuation
2025 (projection)	400-450 million	~8-10% CAGR	Market expansion, new indications

Key takeaways

• TYVASO maintains a leading position in inhaled prostacyclin therapy for PAH.
• Revenue growth aligns with increased diagnosis rates, improved market penetration, and ongoing clinical expansion.
• Price sensitivity and increasing competition from oral agents remain challenges.
• Regulatory exclusivity will expire soon, requiring strategic adaptation for sustained competitiveness.
• Future growth hinges on pipeline developments, market expansion, and pricing strategies.

FAQs

1. When does TYVASO's patent or exclusivity expire?
Orphan drug exclusivity is valid until 2023, after which biosimilar competition is expected.

2. How does TYVASO compare price-wise with alternatives?
It costs roughly $700–$900 per inhalation session, generally higher than oral PAH therapies but justified by targeted delivery and reduced systemic side effects.

3. What are the main clinical advantages of TYVASO?
It provides localized vasodilation with fewer systemic adverse effects compared to intravenous therapies.

4. Are there ongoing clinical trials for TYVASO?
Yes, trials are exploring its use in other pulmonary diseases like interstitial lung disease and COPD-associated pulmonary hypertension.

5. How does reimbursement impact TYVASO sales?
Coverage under national health plans and private insurers is generally favorable in key markets, though formulary restrictions can limit access in some regions.

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References

[1] US Food and Drug Administration (FDA). (2013). FDA approves Tyvaso for pulmonary arterial hypertension. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tyvaso-pulmonary-arterial-hypertension