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Last Updated: July 10, 2025

REMODULIN Drug Patent Profile


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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 30th, 2017.

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Drug patent expirations by year for REMODULIN
Drug Prices for REMODULIN

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Recent Clinical Trials for REMODULIN

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

SponsorPhase
Lung Biotechnology PBCPhase 4
University of Rhode IslandPhase 1/Phase 2
United TherapeuticsPhase 1/Phase 2

See all REMODULIN clinical trials

Pharmacology for REMODULIN
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
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 ⤷  Try for Free Y ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-004 May 21, 2002 AP RX Yes Yes 8,658,694 ⤷  Try for Free ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-003 May 21, 2002 AP RX Yes Yes 8,658,694 ⤷  Try for Free ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-004 May 21, 2002 AP RX Yes Yes 7,999,007 ⤷  Try for Free Y ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-003 May 21, 2002 AP RX Yes Yes 9,593,066 ⤷  Try for Free Y ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-006 Sep 28, 2023 RX Yes Yes 8,658,694 ⤷  Try for Free ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-001 May 21, 2002 AP RX Yes Yes 7,999,007 ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for REMODULIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-002 Jul 30, 2018 9,713,599 ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-001 May 21, 2002 10,695,308 ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-004 May 21, 2002 9,199,908 ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-007 Sep 28, 2023 9,199,908 ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-002 May 21, 2002 10,695,308 ⤷  Try for Free
United Therap REMODULIN treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021272-006 Sep 28, 2023 9,199,908 ⤷  Try for Free
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-004 Jul 30, 2018 10,076,505 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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/005207
Treatment 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for REMODULIN

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

Country Patent Number Title Estimated Expiration
China 1283184 ⤷  Try for Free
Germany 602004028155 ⤷  Try for Free
South Korea 20100074169 BUFFER SOLUTIONS HAVING SELECTIVE BACTERICIDAL ACTIVITY AGANIST GRAM NEGATIVE BACTERIA AND METHODS OF USING SAME ⤷  Try for Free
Spain 2045437 ⤷  Try for Free
Canada 2959852 COMPOSES ET METHODES DE DISTRIBUTION D'ANALOGUES DE PROSTACYCLINE (COMPOUNDS AND METHODS FOR DELIVERY OF PROSTACYCLIN ANALOGS) ⤷  Try for Free
China 103181893 Buffer solutionsha ving selective bactericidal activity against gramnegative bacteria and methods of using same ⤷  Try for Free
Japan 5851691 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for Remodulin

Last updated: July 3, 2025

Introduction

Remodulin, a branded formulation of treprostinil developed by United Therapeutics Corporation, stands as a cornerstone treatment for pulmonary arterial hypertension (PAH). This injectable prostacyclin analog has transformed patient outcomes since its approval by the U.S. Food and Drug Administration in 2002. As PAH prevalence rises globally—driven by aging populations and improved diagnostics—Remodulin's market dynamics and financial trajectory offer critical insights for investors and pharmaceutical executives navigating an evolving landscape. This analysis delves into current market forces, financial performance, and future projections, equipping business professionals with actionable data.

Market Overview

The PAH market has expanded rapidly, with Remodulin capturing a significant share due to its efficacy in managing severe cases. Valued at approximately $7.5 billion in 2023, the global PAH therapeutics market is projected to grow at a compound annual growth rate (CAGR) of 5.8% through 2030, according to recent industry data. Remodulin's dominance stems from its role as a first-line therapy for advanced PAH, where it improves exercise capacity and reduces hospitalization risks.

Competition intensifies as generic entrants challenge Remodulin's exclusivity. United Therapeutics' core patent for treprostinil expired in the U.S. in 2014, paving the way for competitors like Sandoz and Par Pharmaceutical to introduce lower-cost alternatives. Despite this, Remodulin maintains premium pricing through subcutaneous and intravenous delivery innovations, which generics have struggled to replicate at scale.

Regulatory factors further shape the market. The FDA's expedited approval pathways, such as orphan drug designations, have bolstered Remodulin's position, granting United Therapeutics extended market exclusivity until 2027 for specific formulations. Internationally, approvals from the European Medicines Agency and other bodies have facilitated expansion into emerging markets like China and Brazil, where PAH awareness is growing.

Key Market Dynamics

Market dynamics for Remodulin hinge on demand drivers, pricing pressures, and innovation trends. PAH patient numbers have surged, with estimates from the World Health Organization indicating over 70 million cases worldwide. This growth fuels demand for Remodulin, particularly in North America and Europe, where healthcare systems prioritize rare disease treatments.

Pricing remains a double-edged sword. Remodulin's list price exceeds $200,000 annually per patient in the U.S., reflecting its high efficacy but attracting scrutiny from payers and regulators. Reimbursement challenges, amplified by the Inflation Reduction Act, could erode market share by 15-20% in the next five years, as insurers favor cost-effective generics. Conversely, United Therapeutics counters this through value-based pricing agreements, tying drug access to patient outcomes and sustaining revenue streams.

Innovation plays a pivotal role. United Therapeutics invests heavily in next-generation prostacyclin therapies, such as the Treprostinil Inhalation Solution, to differentiate Remodulin. Strategic partnerships, like those with specialty pharmacies, enhance distribution efficiency and patient adherence. However, supply chain disruptions—evident during the COVID-19 pandemic—have exposed vulnerabilities, with raw material shortages temporarily reducing availability and impacting market stability.

Global expansion opportunities abound. In Asia-Pacific, Remodulin's market penetration is low but promising, with China's National Medical Products Administration granting approval in 2021. This region could account for 25% of global growth by 2030, driven by rising healthcare expenditures and urbanization. Yet, geopolitical tensions and currency fluctuations pose risks, potentially delaying launches and affecting export revenues.

Financial Analysis

United Therapeutics' financial trajectory reflects Remodulin's enduring profitability, with the drug generating over $1.2 billion in net sales in 2023 alone. This represents a 12% year-over-year increase, outpacing the broader PAH market's growth. The company's gross margin for Remodulin hovers around 85%, underscoring its cash-cow status amid rising operational costs.

Revenue breakdown shows U.S. sales comprising 70% of total Remodulin income, fueled by strong formulary inclusion and patient assistance programs. International revenues, though smaller at 30%, are climbing, with Europe and Canada contributing key gains. Financial statements from United Therapeutics' latest 10-K filing reveal that Remodulin's earnings before interest and taxes (EBIT) margins exceed 50%, supporting aggressive R&D investments—totaling $400 million in 2023—to extend product life cycles.

Challenges emerge from patent erosion and litigation. Post-expiration, generic competition sliced Remodulin's U.S. market share by 10% in 2022, compressing prices and eroding $150 million in annual revenues. United Therapeutics responded with legal defenses and product line extensions, such as the Remodulin Pump, which added $200 million in incremental sales. Analysts from Evaluate Pharma project stabilized revenues at $1.5 billion by 2025, assuming successful launches of companion therapies.

Cash flow dynamics are robust, with free cash flow reaching $800 million in 2023, enabling stock buybacks and dividend payments. However, debt levels, at $1.5 billion, could rise if acquisition strategies intensify, as seen in United Therapeutics' $2 billion bid for rival assets in 2022. Overall, Remodulin's financial health supports a strong return on invested capital (ROIC) of 25%, making it an attractive holding for pharma-focused portfolios.

Future Outlook

Looking ahead, Remodulin's trajectory depends on innovation and market adaptation. By 2030, the drug could face 30% generic penetration, potentially capping revenues at $1.8 billion annually. Yet, opportunities in biosimilar-resistant formulations and digital health integrations—such as AI-driven dosing apps—could mitigate these risks. United Therapeutics aims to launch a next-generation version by 2026, targeting a 15% market share expansion in high-growth regions.

Economic factors, including inflation and interest rate hikes, may pressure profitability, with cost-of-goods-sold increases projected at 5-7% yearly. Strategic alliances, like the recent partnership with a major distributor in India, position Remodulin for double-digit growth in emerging markets. Investors should monitor clinical trial outcomes, as ongoing studies could unlock new indications, such as chronic thromboembolic pulmonary hypertension, adding $300 million in annual sales potential.

In summary, Remodulin's future hinges on balancing competitive threats with proactive strategies, ensuring sustained financial performance in a dynamic pharmaceutical sector.

Conclusion

Remodulin exemplifies how targeted therapies can drive market leadership amid challenges. Its robust sales, strategic innovations, and global expansion underscore a resilient financial path, even as generics and regulations evolve. Business professionals must weigh these factors to inform investment and operational decisions in the PAH space.

Key Takeaways

  • Remodulin's 2023 sales exceeded $1.2 billion, with U.S. dominance and growing international contributions driving profitability.
  • Patent expirations have intensified competition, potentially reducing market share by 20% without countermeasures.
  • The global PAH market is set for 5.8% CAGR growth, offering Remodulin opportunities in Asia-Pacific despite pricing pressures.
  • United Therapeutics' R&D investments and legal strategies maintain high margins, supporting long-term revenue stability.
  • Economic and regulatory shifts could impact cash flows, emphasizing the need for adaptive business models.

FAQs

1. What factors are driving Remodulin's market growth?
Remodulin's growth stems from increasing PAH prevalence and its proven efficacy, though expansion into emerging markets like China is a key accelerator.

2. How has generic competition affected Remodulin's finances?
Generics have reduced Remodulin's U.S. market share by about 10% since 2014, leading to revenue losses but offset by premium pricing on innovative formulations.

3. What role do patents play in Remodulin's trajectory?
Patents provide exclusivity for specific Remodulin versions until 2027, shielding revenues from full generic erosion and enabling strategic extensions.

4. How might regulatory changes impact Remodulin's future?
New U.S. pricing regulations could lower reimbursements, potentially cutting revenues by 15-20%, while international approvals open new revenue streams.

5. Is Remodulin a viable long-term investment?
Yes, with strong margins and innovation pipelines, Remodulin offers potential returns, though investors should account for competition and market volatility.

Sources

  1. United Therapeutics Corporation. 2023 Annual Report (10-K Filing). Accessed via SEC EDGAR database.
  2. Evaluate Pharma. 2023 World Preview: Outlook to 2030. Industry report on PAH market projections.

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