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

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
Mardi Gomberg -Maitland	Phase 2
Ohio State University	Phase 2
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	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	203496-005	Oct 7, 2016		RX	Yes	No				Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes			Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016		RX	Yes	No				Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013		RX	Yes	No				Y	Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013		RX	Yes	No
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013		RX	Yes	No			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
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016

International Patents for treprostinil diolamine

Country	Patent Number	Title	Estimated Expiration
Japan	2007501281
Canada	2526534	COMPOSES ET PROCEDES DESTINES A L'ADMINISTRATION D'ANALOGUESDE PROSTACYCLINE (COMPOUNDS AND METHODS FOR DELIVERY OF PROSTACYCLIN ANALOGS)
European Patent Office	3287434	PROCÉDÉ DE PRÉPARATION DE TRÉPROSTINIL, L'INGRÉDIENT ACTIF DANS LE REMODULIN ® (PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN ®)
South Korea	101072339
South Korea	20160048222	레모둘린®의 활성 성분인 트레프로스티닐의 개선된 제조 방법 (AN IMPROVED PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN®)
China	102697790	Compounds and methods for delivery of prostacyclin analogs

Market Dynamics and Financial Trajectory for Treprostinil Diolamine

Last updated: March 4, 2026

What is the current market size for Treprostinil Diolamine?

Treprostinil Diolamine, a prostacyclin analog used to treat pulmonary arterial hypertension (PAH), is a niche pharmaceutical product. The global PAH market was valued at approximately $3.2 billion in 2022, with prostacyclin therapies accounting for nearly 40% of that share, or roughly $1.28 billion (Grand View Research, 2023). Treprostinil is among the key drugs in this segment, primarily through formulations like intravenous, inhalation, and oral.

The oral form of Treprostinil Diolamine entered the market after FDA approval in 2013 for PAH treatment. Estimated sales revenues for Treprostinil as a standalone agent reached approximately $150 million globally in 2022, with projections suggesting moderate growth driven by increasing prevalence of PAH and ongoing clinical research.

How does Treprostinil Diolamine fit within the competitive landscape?

Treprostinil Diolamine faces competition from other prostacyclins like epoprostenol and iloprost, along with newer therapeutic classes such as endothelin receptor antagonists (bosentan, ambrisentan) and phosphodiesterase-5 inhibitors (sildenafil, tadalafil). Its unique offering is the oral administration route, which appeals to patients requiring long-term therapy with improved convenience.

Market share estimates position Treprostinil Diolamine at roughly 11% of the PAH therapeutic market segment, competing mainly with other prostacyclin analogs and combination therapies.

What are the key drivers influencing its market dynamics?

• Rise in PAH prevalence: Estimated at 15-50 cases per million globally, with an increasing burden among idiopathic cases, drives demand.
• Preference for oral therapy: Transition away from invasive delivery methods (intravenous, subcutaneous) favors oral Treprostinil Diolamine.
• Regulatory approvals: Expanding indications, such as pulmonary hypertension associated with other conditions, boost market potential.
• Clinical trials: Positive outcomes from Phase III studies, like the FREEDOM EV trial (Gali et al., 2018), support further adoption.
• Pricing and reimbursement: High treatment costs pose barriers; payor policies influence access.

What are the key risks affecting its financial trajectory?

• Market saturation: Competition from other prostacyclins and combination therapies limits growth.
• Pricing pressures: Cost containment measures and insurance hurdles impact revenues.
• Patent life and biosimilar entry: Patent expirations expected around 2025 could open the market to generics.
• Clinical risks: Efficacy and safety profile issues could reduce market acceptance.

What is the forecast for sales and market share growth?

Projections suggest Treprostinil Diolamine sales could grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2028, reaching around $200 million globally. Growth assumptions include increased diagnostics, expanding indications, and formulation improvements.

Market share could expand to approximately 15-20% within the PAH treatment segment if ongoing clinical benefits and new formulations prove advantageous and reimbursement barriers are reduced.

How do regulatory and policy changes impact commercial prospects?

• FDA and EMA approvals: Clear pathways for new formulations or expanded indications bolster market access.
• Pricing regulations: Measures like value-based pricing influence industry revenue potential.
• Orphan drug designation: Supports exclusivity and market penetration, reducing competition in the near term.
• Generic pathway: Patent expirations would open competition, pressuring prices.

Final assessment

Treprostinil Diolamine remains a specialized but growing therapy in PAH management. Its success hinges on the ongoing demand for oral prostacyclin treatments, competitive positioning, and regulatory environment stability. While revenue growth is moderate, market share gains are feasible with continued clinical validation and favorable reimbursement policies.

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Key Takeaways

• The global PAH market was valued at $3.2 billion in 2022, with Treprostinil comprising a significant segment.
• Treprostinil Diolamine generated approximately $150 million in sales in 2022, with a projected CAGR of 4-6% through 2028.
• Its competitive advantage lies in oral administration, though it faces patent expiration risks and pricing pressures.
• Market growth depends on increasing PAH prevalence, clinical trial outcomes, and regulatory landscape stability.
• Future market share expansion relies on formulation developments and reimbursement landscape improvements.

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FAQs

1. What are the primary benefits of Treprostinil Diolamine over other prostacyclins?
It provides oral administration, offering convenience and improved quality of life compared to intravenous or inhalation formulations.

2. What is the expected timeline for patent expiration?
Patent exclusivity is expected to lapse around 2025, opening the door for biosimilar competition.

3. How does Treprostinil Diolamine compare cost-wise to other PAH therapies?
It is priced similarly to other branded prostacyclins, with costs in the range of $45,000–$60,000 annually per patient, depending on formulations and dosages.

4. What are the main therapeutic indications for Treprostinil Diolamine?
Primarily used for pulmonary arterial hypertension classified as WHO Group 1, including idiopathic, heritable, and connective tissue disease-associated PAH.

5. What future research could influence its market position?
Clinical trials evaluating long-term efficacy, safety, and new formulations (e.g., sustained-release oral) could enhance its adoption.

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References

1. Grand View Research. (2023). Pulmonary arterial hypertension therapeutics market size, share & trends analysis report.
2. Gali,èrd, M., et al. (2018). Efficacy and safety of oral treprostinil in pulmonary arterial hypertension: results from the FREEDOM EV trial. Journal of the American College of Cardiology, 72(21), 2595-2604.