Treprostinil diolamine - Generic Drug Details

What are the generic drug sources for treprostinil diolamine and what is the scope of patent protection?

Treprostinil diolamine is the generic ingredient in one branded drug marketed by United Therap and is included in one NDA. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil diolamine has fifty-nine patent family members in eight countries.

There are two drug master file entries for treprostinil diolamine. One supplier is listed for this compound.

Summary for treprostinil diolamine

International Patents:	59
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for treprostinil diolamine
DailyMed Link:	treprostinil diolamine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for treprostinil diolamine

Constraining patent/regulatory exclusivity:

8,747,897

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for treprostinil diolamine

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

Sponsor	Phase
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 2
Mardi Gomberg -Maitland	Phase 2
Ohio State University	Phase 2

See all treprostinil diolamine clinical trials

Pharmacology for treprostinil diolamine

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for treprostinil diolamine

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

Paragraph IV (Patent) Challenges for TREPROSTINIL DIOLAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORENITRAM	Extended-release Tablets	treprostinil diolamine	0.125 mg and 5 mg	203496	1	2020-12-28
ORENITRAM	Extended-release Tablets	treprostinil diolamine	0.25 mg and 1 mg	203496	1	2016-05-19
ORENITRAM	Extended-release Tablets	treprostinil diolamine	2.5 mg	203496	1	2015-12-24

US Patents and Regulatory Information for treprostinil diolamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013		RX	Yes	No	9,393,203		Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013		RX	Yes	No	7,417,070			Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes	11,723,887			Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013		RX	Yes	No	8,747,897		Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016		RX	Yes	No
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes	8,349,892		Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No	11,723,887			Y

Expired US Patents for treprostinil diolamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016	9,422,223
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013	9,050,311
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016	9,278,901
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013	7,544,713
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013	5,153,222
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013	8,252,839
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013	9,050,311

International Patents for treprostinil diolamine

Country	Patent Number	Title	Estimated Expiration
South Korea	20120017058
Japan	2012526140
European Patent Office	2010189	DISPOSITIF OSMOTIQUE D'ADMINISTRATION D'UN MÉDICAMENT COMPRENANT UN PROMOTEUR DE LA LIBÉRATION (OSMOTIC DRUG DELIVERY SYSTEM COMPRISING RELEASE ENHANCING AGENT)
Japan	5851691
South Korea	101898407
Japan	2011506599
Japan	6242371

Market Dynamics and Financial Trajectory for Treprostinil Diolamine

Last updated: July 28, 2025

Introduction

Treprostinil diolamine is a vasoactive prostacyclin analog primarily prescribed for the treatment of pulmonary arterial hypertension (PAH). Approved by the U.S. Food and Drug Administration (FDA), it has established itself as a vital therapeutic option in managing this rare but severe condition. This article explores the evolving market landscape and the financial trajectory of treprostinil diolamine, emphasizing its strategic position within the pharmaceutical industry, influencing factors for growth, competition, and future outlooks.

Pharmacological Profile and Therapeutic Significance

Treprostinil diolamine (marketed as Tyvaso and other formulations) exerts vasodilatory effects, improving cardiac output and pulmonary artery pressure in PAH patients [1]. Its advantages over earlier treatments include longer half-life, stability, and greater flexibility in dosing routes, including inhalation, subcutaneous, and intravenous administrations. These therapeutic benefits underpin its sustained clinical relevance and market demand.

Market Landscape and Drivers

1. Growing Prevalence of Pulmonary Arterial Hypertension

The PAH patient population continues to expand globally owing to increased awareness, improved diagnostic techniques, and a better understanding of disease pathology. The World Health Organization estimates that PAH affects 15-50 per million individuals worldwide, with higher prevalence among women [2]. Rising diagnosis rates elevate demand for effective pharmacological therapies, sustaining treprostinil diolamine’s market base.

2. Therapeutic Advantages and Product Differentiation

Treprostinil’s inhalation delivery offers targeted pulmonary vasodilation, with a favorable safety profile relative to intravenous options, which entails risks like infections and catheter-related complications. Its route of administration aligns with patient preference for non-invasive, outpatient therapies. The pharmaceutical industry’s focus on enhancing patient adherence supports the adoption of inhaled treprostinil.

3. Regulatory Approvals and Expanding Indications

Initially approved for PAH, ongoing clinical trials investigating treprostinil’s efficacy in other pulmonary vascular diseases or chronic thromboembolic pulmonary hypertension (CTEPH) could open new markets. Additionally, regulatory collaborations aim to streamline approval processes in emerging markets.

4. Market Penetration and Reimbursement Policies

Reimbursement strategies significantly influence sales trajectories. Countries with comprehensive healthcare coverage and supportive policies facilitate patient access to treprostinil therapies. Conversely, high costs and reimbursement hurdles in certain regions pose challenges.

Competitive Landscape

1. Existing Market Players

Major pharmaceutical companies such as United Therapeutics (Tyvaso inhalation solution), Bayer, and Sunovion compete within the treprostinil arena. United Therapeutics holds significant market share with its inhalation product Tyvaso, supported by a broad distribution network and extensive clinical validation [3].

2. Pipeline and Biosimilar Developments

Emerging biosimilars and generics threaten to disrupt the market. Although patent protections extend into the late 2020s, patent expirations may open price competition, impacting revenue streams for incumbent firms.

3. Adjacent Therapeutics and Treatment Alternatives

Other PAH treatments include endothelin receptor antagonists (e.g., ambrisentan), phosphodiesterase-5 inhibitors (e.g., sildenafil), and soluble guanylate cyclase stimulators (e.g., riociguat). Combination therapies are increasingly adopted, positioning treprostinil within a broader treatment paradigm that influences market share.

Financial Trajectory and Revenue Outlook

1. Revenue Growth Trends

Treprostinil diolamine’s global sales have demonstrated steady growth, driven by increased diagnosis and expanded indications. According to market research, the PAH drug market is projected to reach USD 3.5 billion worldwide by 2025, with treprostinil accounting for an estimated USD 600–800 million of this figure [4].

2. Pricing Dynamics and Cost Considerations

High manufacturing costs, coupled with the specialized nature of inhaled therapies, underlie premium pricing strategies. Effective cost-management and patent protections have historically stabilized revenue flow. However, impending patent expirations and biosimilar entries could pressure prices downward.

3. Impact of Regulatory and Market Disruptors

Regulatory approvals for generic versions or biosimilars could significantly erode revenues. Conversely, new formulations or combination therapies, fast-tracked through regulatory pathways, could boost sales if they demonstrate superior efficacy or safety.

4. Geographical Market Expansion

Emerging markets, notably Asia-Pacific and Latin America, offer growth opportunities due to rising healthcare expenditure and increasing PAH awareness. Local regulatory hurdles and pricing policies remain impediments but are gradually easing.

Challenges and Opportunities

Challenges

• Patent Cliff: Expiration of key patents opens the market to generics, risking revenue loss.
• Pricing Pressures: Healthcare reforms and austerity measures in various countries threaten pricing power.
• Market Competition: Alternative therapies and combination regimens diminish treprostinil’s market share.

Opportunities

• Orphan Drug Designation: Continued designation sustains exclusivity and marketing incentives.
• Pipeline Expansion: Development of new delivery devices and formulations can enhance patient adherence and clinical outcomes.
• Strategic Collaborations: Partnerships with biotech firms and healthcare providers facilitate market penetration.

Future Outlook

The trajectory for treprostinil diolamine hinges on sustained clinical efficacy, strategic patent management, and adaptive marketing in emerging economies. Market forecasts suggest modest CAGR growth (around 4–6%) over the next five years, contingent upon regulatory stability and competitive positioning [4]. Innovations in delivery systems, such as nano-enhanced inhalers or combination therapies, could catalyze market expansion and profitability.

Key Takeaways

• Increasing PAH diagnoses and the clinician preference for inhaled therapies position treprostinil diolamine favorably in the PHARMA landscape.
• Patent cliffs and biosimilar entries are primary risks to revenue sustainability; proactive patent strategies and pipeline innovations are vital.
• Expanding into emerging markets offers significant growth, provided pricing and reimbursement challenges are addressed.
• Strategic collaborations and clinical pipeline expansion will be crucial in maintaining market leadership.
• Overall, while facing competitive and regulatory pressures, treprostinil diolamine remains a cornerstone therapy with stable financial prospects driven by demographic and therapeutic trends.

FAQs

1. How does treprostinil diolamine compare to other PAH treatments?
Treprostinil offers the advantage of inhaled administration with targeted pulmonary vasodilation, reducing systemic side effects compared to intravenous forms. It is often used in combination with other PAH therapies to improve outcomes.

2. What are the main patent challenges facing treprostinil diolamine?
Patent expirations are anticipated in the late 2020s, opening pathways for biosimilar competitors and generics, which could impact revenue streams significantly.

3. Are there significant emerging markets for treprostinil diolamine?
Yes, Asia-Pacific, Latin America, and parts of Eastern Europe are showing growing demand, driven by increasing diagnosis rates and healthcare investments.

4. What role do regulatory agencies play in shaping treprostinil’s market?
Regulatory approval processes and pathways—such as orphan drug designations—assist in market exclusivity and facilitate timely access, while also controlling entry of biosimilars.

5. How might upcoming innovations influence treprostinil’s market share?
Advancements like new delivery devices, combination therapies, and personalized treatment regimens could enhance efficacy, adherence, and expand the market, offsetting competitive threats.

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References

[1] Efficacy and safety profiles of treprostinil in pulmonary arterial hypertension, American Journal of Respiratory and Critical Care Medicine, 2021.
[2] Pulmonary hypertension epidemiology, Lancet Respir Med, 2020.
[3] United Therapeutics’ market strategy, Financial Times, 2022.
[4] Global PAH drug market forecast, MarketResearch.com, 2022.