REMODULIN Drug Patent Profile

When do Remodulin patents expire, and what generic alternatives are available?

Remodulin is a drug marketed by United Therap and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-one patent family members in seven countries.

The generic ingredient in REMODULIN 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 Remodulin

A generic version of REMODULIN was approved as treprostinil by SANDOZ on November 30^th, 2017.

Summary for REMODULIN

International Patents:	31
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	30
Patent Applications:	2,494
Drug Prices:	Drug price information for REMODULIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REMODULIN
What excipients (inactive ingredients) are in REMODULIN?	REMODULIN excipients list
DailyMed Link:	REMODULIN at DailyMed

See drug prices for REMODULIN

Recent Clinical Trials for REMODULIN

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

Sponsor	Phase
Lung Biotechnology PBC	Phase 4
Rhode Island Hospital	Phase 1/Phase 2
University of Rhode Island	Phase 1/Phase 2

See all REMODULIN clinical trials

Pharmacology for REMODULIN

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for REMODULIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 REMODULIN

REMODULIN is protected by five 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	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-001	Jul 30, 2018		DISCN	No	No	9,593,066			Y
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes	8,658,694
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-003	May 21, 2002	AP	RX	Yes	Yes	8,658,694
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes	7,999,007		Y
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-003	May 21, 2002	AP	RX	Yes	Yes	9,593,066			Y
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-006	Sep 28, 2023		DISCN	Yes	No	8,658,694

Expired US Patents for REMODULIN

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

EU/EMA Drug Approvals for REMODULIN

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 REMODULIN

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

Country	Patent Number	Title	Estimated Expiration
Japan	3717053
Canada	2710205	PROCEDE AMELIORE DE PREPARATION DE TREPROSTINIL, L'INGREDIENT ACTIF DANS LE REMODULIN (AN IMPROVED PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN)
China	101647792	Use of treprostinil to treat and prevent ischemic lesions
Japan	2016047850	グラム陰性菌に対して選択的殺菌活性を有するバッファー溶液およびそれを使用する方法 (BUFFER SOLUTIONS HAVING SELECTIVE BACTERICIDAL ACTIVITY AGAINST GRAMNEGATIVE BACTERIA AND METHODS OF USING SAME)
South Korea	20100074169	BUFFER SOLUTIONS HAVING SELECTIVE BACTERICIDAL ACTIVITY AGANIST GRAM NEGATIVE BACTERIA AND METHODS OF USING SAME
Spain	2198760

Market Dynamics and Financial Trajectory for Remodulin (Treprostinil)

Last updated: July 27, 2025

Introduction

Remodulin, the brand name for treprostinil, is a critical therapeutic agent used primarily to treat pulmonary arterial hypertension (PAH). Since its FDA approval in 2002, Remodulin has established a strategic position within the niche of vasoactive agents targeting PAH, a progressive and potentially fatal disease characterized by high pulmonary arterial pressure leading to right heart failure. Understanding the evolving market dynamics and financial trajectory of Remodulin necessitates a comprehensive analysis of its regulatory landscape, competitive environment, technological advancements, and economic factors influencing its sales.

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Market Overview

Therapeutic Indication and Patient Demographics

Remodulin is indicated for PAH patients, including those who are classified as NYHA Functional Class II-IV, with specific approval for subcutaneous (SC) and intravenous (IV) administration. The PAH market, estimated to be valued at approximately USD 4.4 billion in 2022 (Grand View Research), is driven by a growing prevalence of PAH, increased diagnosis, and expanding insurance coverage. The global patient population for PAH is projected to expand, fueled by better diagnostic modalities and heightened awareness.

Key Competitors and Treatment Landscape

Remodulin operates within a competitive milieu populated by other prostacyclin analogs such as Epoprostenol (Flolan), Iloprost, and newer oral agents like Riociguat and Selexipag. The unique delivery methods of Remodulin (continuous infusion) distinguish it but also pose challenges related to administration complexity and Quality of Life (QoL) considerations.

Biotech and pharmaceutical players like United Therapeutics (the manufacturer of Remodulin), Arena Pharmaceuticals, and Bayer have invested heavily in PAH therapies, fostering a highly competitive environment. The advent of oral prostacyclin mimetics and emerging gene therapies threaten Remodulin’s market share, requiring strategic positioning by United Therapeutics.

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Market Dynamics Influencing Remodulin

Regulatory and Reimbursement Factors

In the United States, continued regulatory support by the FDA through programs like Fast Track and Priority Review has facilitated timely approvals for newer formulations of treprostinil, such as oral and inhaled versions. Medicare, Medicaid, and private insurers' reimbursement policies significantly impact market penetration, especially considering the high costs associated with continuous infusion therapy, which exceeds USD 50,000 annually.

Recent policy shifts favoring value-based care and cost containment exert both pressure and opportunity. For instance, United Therapeutics' expanded evidence generation around device innovations and biosimilars could alter reimbursement models favorably.

Technological Innovations and Formulation Developments

Remodulin’s initial formulation involved continuous infusion, typically administered via implantable pumps or external devices, creating adherence issues and infection risks. Recent advancements include the development of extended-release formulations and the exploration of oral treprostinil (Orenitram), approved in 2013, and inhaled versions (Tyvaso).

Enhanced delivery systems, including subcutaneous pumps with better portability and reduced infection risk, continue to evolve. These innovations are crucial for expanding the treatment’s appeal, especially among younger or more active patients.

Market Penetration and Adoption Trends

Despite the efficacy of Remodulin, adoption rates are influenced by administration complexity, patient preference, and competing therapies. The shift toward oral medications has increased focus on formulations like Orenitram, which offers potentially improved adherence, although they may not replicate the rapid symptom relief of infusion therapies.

Additionally, the COVID-19 pandemic initially disrupted healthcare routines and patient access but subsequently accelerated telemedicine and home-based care models, favoring the continued use of established therapies like Remodulin in outpatient settings.

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Financial Trajectory and Sales Performance

Historical Revenue Trends

United Therapeutics reported revenues for Remodulin consistently in the hundreds of millions of dollars annually, with 2021 sales approximating USD 700 million globally ([1]). The product remains a cornerstone in PAH management, especially for severe cases requiring continuous infusion.

Drivers of Revenue Growth

• Increased Prevalence of PAH: Rising diagnosis rates expand the patient pool.
• Expanded Use in Refractory Cases: Remodulin’s efficacy in severe or refractory PAH sustains demand.
• Global Expansion: Emerging markets in Asia and Latin America show growth potential despite challenges around healthcare infrastructure.
• New Formulations and Delivery Innovations: Improved convenience and safety profiles encourage persistent use and potential price premiums.

Threats and Market Challenges

• Pricing Pressures: Payers seek cost-effective alternatives, especially oral agents with comparable efficacy.
• Patent Expirations and Biosimilar Competition: Although United Therapeutics maintains market exclusivity, the threat of biosimilars or generics in the future may impact pricing.
• Patient Preferences: Preference for less invasive options curtails growth opportunities for infusion-only therapies.

Forecast and Future Outlook

Analysts project that the PAH drug market — and by extension, Remodulin — will grow at a CAGR of approximately 8-10% over the next five years, driven by increased prevalence, technological advances, and geographic expansion. United Therapeutics' diversification into newer formulations of treprostinil, coupled with ongoing investments in pipeline innovations, positions Remodulin favorably within this trajectory.

Sales are anticipated to stabilize or slightly decline as oral and inhaled alternatives gain market share, yet Remodulin’s established efficacy and critical role in severe PAH maintain its revenue contribution. The integration of digital health tools for infusion management could further enhance adherence and lifetime customer value.

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Regulatory and Future Market Opportunities

In 2022, United Therapeutics received FDA approval for Tyvaso DPI, an inhaled version of treprostinil, representing a strategic diversification. The pipeline also includes oral treprostinil combinations and biosimilar development, aiming to expand value and accessibility.

Potential upcoming opportunities involve:

• Biosimilar Entry: Price competition may challenge Remodulin’s premium valuation.
• Gene and Cell Therapies: Long-term, these innovative treatments could redefine PAH management.
• Personalized Medicine: Pharmacogenomic approaches could optimize patient selection, improving outcomes and retention.

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Conclusion

Remodulin maintains a vital position in PAH therapy, supported by its proven efficacy for severe cases and ongoing technological enhancements. Market dynamics are shaped by regulatory progress, technological innovation, payer strategies, and patient preferences. While competition and reimbursement pressures present challenges, significant growth prospects remain for Remodulin within a growing global PAH market. Strategic positioning with new formulations, personalized approaches, and expansion into emerging markets are essential for maintaining its financial trajectory.

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Key Takeaways

• Remodulin remains a market leader in severe PAH, generating substantial revenues despite evolving competition.
• Innovation in delivery methods, including inhalable and oral treprostinil, influences adoption trends and competitive positioning.
• Patient preferences and regulatory policies will continue to shape product uptake—cost, safety, and convenience remain key.
• Global expansion offers growth opportunities, especially in developing markets with rising PAH prevalence.
• Upcoming biosimilar and pipeline developments could pose pricing and market share challenges, requiring agile strategic responses.

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FAQs

1. How does Remodulin differentiate itself from other PAH treatments?
Remodulin provides continuous infusion of treprostinil, offering potent vasodilation and antiproliferative effects, especially for severe or refractory PAH cases. Its delivery method ensures consistent drug levels, which is crucial for managing advanced disease stages.

2. What are the main challenges facing Remodulin’s market growth?
Challenges include the invasive administration route, high costs, patient adherence issues, and increasing competition from oral and inhaled therapies that are less burdensome.

3. How are technological advances impacting Remodulin’s market share?
Innovations like portable infusion devices and novel formulations improve patient convenience and safety, potentially expanding its use. Conversely, the rise of oral treprostinil formulations may divert some patients from infusion-based therapy.

4. What is the outlook for biosimilars of Remodulin?
While biosimilars could decrease pricing pressure in the future, current patent protections limit near-term biosimilar entry. Market entrants are likely several years away, providing a window for continued revenue stability.

5. Which regions present the most growth potential for Remodulin?
Emerging markets in Asia, Latin America, and Eastern Europe, where PAH diagnosis and treatment infrastructure are expanding, represent significant growth opportunities, contingent on localized reimbursement policies and healthcare access.

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Sources:

[1] United Therapeutics Annual Reports and Financial Statements, 2021.