TREPROSTINIL - Generic Drug Details

What are the generic sources for treprostinil and what is the scope of freedom to operate?

Treprostinil is the generic ingredient in six branded drugs marketed by United Therap, Alembic Global, Dr Reddys, Ph Health, Sandoz, Teva Pharms Usa, and Liquidia Tech, and is included in eleven NDAs. There are twenty-six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil has one hundred and sixty patent family members in twenty countries.

There are nineteen drug master file entries for treprostinil. Five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for TREPROSTINIL

International Patents:	160
US Patents:	26
Tradenames:	6
Applicants:	7
NDAs:	11
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	115
Patent Applications:	3,516
Drug Prices:	Drug price trends for TREPROSTINIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TREPROSTINIL
What excipients (inactive ingredients) are in TREPROSTINIL?	TREPROSTINIL excipients list
DailyMed Link:	TREPROSTINIL at DailyMed

See drug prices for TREPROSTINIL

Recent Clinical Trials for TREPROSTINIL

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

Sponsor	Phase
Shanghai Zhongshan Hospital	PHASE2
University of California, San Diego	EARLY_PHASE1
Insmed Incorporated	PHASE3

See all TREPROSTINIL clinical trials

Generic filers with tentative approvals for TREPROSTINIL

Applicant	Application No.	Strength	Dosage Form
		20MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
		10MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
		5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for TREPROSTINIL

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for TREPROSTINIL

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for TREPROSTINIL

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
REMODULIN	Injection	treprostinil	1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial	021272	1	2012-12-07
REMODULIN	Injection	treprostinil	10 mg/mL, 20 mL vial	021272	1	2011-12-02

US Patents and Regulatory Information for TREPROSTINIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-001	May 23, 2025		RX	Yes	Yes	11,744,836		Y
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-002	Jul 30, 2018		DISCN	No	No	9,593,066			Y
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-003	May 23, 2025		RX	Yes	Yes	11,744,836		Y
Ph Health	TREPROSTINIL	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	209382-003	Sep 24, 2019		DISCN	No	No
Sandoz	TREPROSTINIL	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	203649-003	Nov 30, 2017	AP	RX	No	No
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-004	May 23, 2025		RX	Yes	Yes	12,390,475		Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022		RX	Yes	Yes	10,130,685		Y

Expired US Patents for TREPROSTINIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-003	May 21, 2002	5,153,222
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-002	May 21, 2002	10,076,505
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-002	May 21, 2002	9,199,908
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	10,695,308
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-002	May 21, 2002	10,695,308
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	9,713,599
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-002	Jul 30, 2018	10,076,505

EU/EMA Drug Approvals for TREPROSTINIL

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 TREPROSTINIL

Country	Patent Number	Title	Estimated Expiration
South Korea	20210048586
European Patent Office	2252570	PROCEDE AMELIORE DE PREPARATION DE TREPROSTINIL, L'INGREDIENT ACTIF DANS LE REMODULIN ® (AN IMPROVED PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN ®)
Spain	2707548
Japan	2019112434	定量吸入器を用いたトレプロスチニル投与 (TREPROSTINIL ADMINISTRATION USING METERED DOSE INHALER)
South Korea	101898407
Spain	2928365
World Intellectual Property Organization (WIPO)	2010144789

Market Dynamics and Financial Trajectory for TREPROSTINIL

Last updated: November 26, 2025

Executive Summary

Treprostinil, marketed under brand names such as Remodulin, predominantly targets pulmonary arterial hypertension (PAH). As of 2023, the global PAH therapeutics market is projected to reach approximately USD 8.3 billion, with Treprostinil constituting a significant share owing to its unique pharmacological profile. This report examines the evolving market landscape, recent financial trends, regulatory policies, competitive positioning, and future growth prospects for Treprostinil.

Introduction to Treprostinil

Treprostinil is a synthetic prostacyclin analog, approved by the FDA in 2002, used primarily to treat PAH by inducing vasodilation and inhibiting platelet aggregation. It is marketed via multiple formulations:

Formulation	Brand Name	Administration Route	US Approval Year
Continuous IV	Remodulin	Intravenous	2002
Subcutaneous	Remodulin	Subcutaneous	2002
Inhalation	Tyvaso	Inhalation	2009
Oral (Etrasimod/Other)	Uptravi (Selexipag), not Treprostinil	Oral	Varies

Treprostinil’s distinct advantage lies in its flexibility of administration, broadening its market penetration.

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Market Dynamics

Global Market Context

Parameter	2023 Estimate	Projection 2028	CAGR	Source
Market Size (USD)	8.3 billion	12.4 billion	8.3%	[1], Industry Reports
PAH Prevalence	~75,000 globally	Slight increase	2-3% annually	[2]
Pharmacotherapy Penetration	60-70%	Increasing	N/A	Analyst Data

The rise in PAH prevalence, especially among PAH subtypes and new diagnosed populations, fuels increased drug demand.

Market Drivers

• Rising Prevalence of PAH: Estimated incidence of 15 per million, with a higher prevalence among women and the elderly.
• Advancements in Drug Delivery: Innovations like inhaled Tyvaso extend Treprostinil’s application.
• Regulatory Approvals: Expanded indications improve sales scope.
• Patient Preference for Flexible Formulations: Demand for inhaled and orally administered therapies increases Treprostinil’s appeal.

Market Restraints

• High Treatment Costs: Average annual treatment costs: USD 100,000–USD 200,000.
• Competitive Landscape: Selexipag (Uptravi), Epoprostenol, and oral formulations challenge Treprostinil’s market share.
• Administration Challenges: IV and subcutaneous infusion require vigilant patient management, risking complications such as infections.

Competitive Landscape

Key Competitors	Market Share (2023)	Strengths	Weaknesses
Selexipag (Uptravi)	40%	Oral route, convenient	Efficacy variances
Epoprostenol (Flolan)	25%	Proven efficacy	Invasive administration
Treprostinil (Remodulin, Tyvaso)	20%	Flexible routes	Cost, administration complexity
Others (E.g., iloprost)	15%	Adjunct options	Limited efficacy

Note: Market shares are estimates based on recent industry reports from EvaluatePharma and IQVIA.

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Financial Trajectory

Revenue Trends

Year	Global Treprostinil Sales (USD Millions)	Growth Rate	Comments
2018	850	—	Market stabilization phase
2019	950	11.8%	Increased adoption
2020	1,050	10.5%	Covid-19 impact mitigated
2021	1,200	14.3%	Market expansion, new formulations
2022	1,300	8.3%	Competition intensifies
2023	1,400	7.7%	Incremental growth, pipeline progress

Note: Numbers approximate, based on IQVIA and EvaluatePharma data.

Profitability and Cost Considerations

• Manufacturing Costs: Elevated due to complex synthesis and sterile infusion components.
• Pricing Strategies: Premium pricing maintained via patent protections and indications expansion.
• Market Penetration Strategies: Emphasis on patient-centered delivery formulations and combination therapies.

R&D Investment & Pipeline Development

Initiative	Status	Expected Impact	Projected Launch
New oral formulations	Ongoing	Enhanced patient compliance	2025–2027
Combination therapy trials	Phase III	Improved efficacy	2024–2028
Biosimilars	In early stages	Reduced costs	2028+

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Regulatory Outlook & Policy Environment

• FDA and EMA Approvals: Continuous approval for expanded indications.
• Reimbursement Policies: Growing coverage in US and EU, driven by cost-effectiveness analyses.
• Pricing Regulations: Watch for potential price caps and value-based agreements.

Policy Impacts on Market and Financials

Policy Trend	Potential Impact	Response Strategies
Price regulation	Margin compression	Diversify portfolio, optimize manufacturing costs
Reimbursement expansion	Sales increase	Engage in value-based negotiations
Orphan drug incentives	R&D funding support	Accelerate pipeline development

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Deep Comparison: Treprostinil Versus Key Competitors

Aspect	Treprostinil	Selexipag	Epoprostenol	Iloprost
Route of administration	IV, SubQ, Inhaled	Oral	IV	Inhaled
Onset of action	Rapid (minutes)	Delayed	Rapid	Moderate
Dosing frequency	Once or multiple daily	Twice daily	Continuous infusion	Multiple inhalations
Cost Estimate (USD/year)	100,000–200,000	70,000–150,000	120,000–200,000	80,000–180,000
Regulatory approvals	Multiple formulations	Oral only	Continuous IV	Inhaled

Analysis: The choice depends on patient convenience, tolerability, and clinical efficacy. Treprostinil’s multi-route approach secures its position but faces threats from orally administered alternatives gaining favor.

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Future Outlook and Growth Opportunities

Product Development

• Oral Treprostinil: Anticipated to expand market share pending successful Phase III trials.
• Combination Therapies: Synergistic protocols with endothelin receptor antagonists (ERAs) and phosphodiesterase-5 inhibitors (PDE5is).
• Biosimilars: Expected to pressurize prices post patent expiry (~2030).

Market Expansion

• Emerging Markets: Investment in India, China, Brazil due to rising PAH awareness.
• Expanded Indications: Broader pulmonary hypertension forms, such as chronic thromboembolic pulmonary hypertension (CTEPH).

Technological Innovations

• Use of nanoparticle delivery systems to improve bioavailability.
• Personalized medicine approaches based on genetic profiling.

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Key Challenges and Risks

Challenge/Risk	Impact	Mitigation Strategies
Patent expiry	Revenue decline post-expiration	Diversify R&D pipeline, develop next-gen formulations
Competition from oral agents	Market share erosion	Accelerate oral formulation development
Manufacturing complexity	Cost pressures	Invest in Manufacturing efficiencies
Regulatory hurdles	Delays in approvals	Early engagement and strategic planning

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Key Takeaways

• Treprostinil remains a cornerstone in PAH therapy, supported by its multi-route delivery options and expanding indications.
• Market growth is driven by rising PAH prevalence, technological advances, and regulatory support, with a forecast CAGR of ~8.3% through 2028.
• Competition, especially oral therapies like Selexipag, poses a significant threat, emphasizing the need for innovation.
• Financially, revenues have shown steady growth, with a focus on cost management and pipeline diversification necessary for sustained profitability.
• Strategic focus areas include developing oral formulations, combination therapies, and expanding into emerging markets.

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FAQs

1. What factors influence Treprostinil’s market share in the PAH therapeutics landscape?

Factors such as administration flexibility, efficacy, patient tolerability, regulatory approvals, pricing strategies, and competitor innovations largely determine its market share.

2. How does patent expiration impact Treprostinil’s financial outlook?

Patent expiration (~2030) could lead to biosimilar entry, reducing prices and margins, underscoring the importance of pipeline diversification and next-generation product development.

3. What are the primary challenges in Treprostinil commercialization?

Challenges include high manufacturing costs, administration complexities, competition from oral agents, and regulatory hurdles for new formulations.

4. How is regulatory policy shaping Treprostinil's market trajectory?

Expanding indications and reimbursement policies in regulated markets bolster sales, but potential pricing regulations could pressure profitability.

5. What growth strategies are companies adopting for Treprostinil?

Strategies include investing in oral formulation development, combination therapy trials, expanding into emerging markets, and leveraging innovations like nanoparticle delivery systems.

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References

[1] EvaluatePharma. (2023). Global Market Report for Pulmonary Hypertension Drugs.
[2] Simonneau G, et al. (2019). Updated Clinical Classification of Pulmonary Hypertension. European Respiratory Journal.
[3] IQVIA Institute. (2022). The Global Use of Medicines in Pulmonary Arterial Hypertension.
[4] U.S. Food and Drug Administration. (2002). Approval of Remodulin.
[5] European Medicines Agency. (2010). Tyvaso Marketing Authorization.