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:	2,324
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				Y
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-003	May 21, 2002	AP	RX	Yes	Yes

Expired US Patents for REMODULIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-007	Sep 28, 2023
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-002	May 21, 2002
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-002	May 21, 2002

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
Austria	E473736
Canada	2549724	UTILISATION DU TREPROSTINIL DANS LE TRAITEMENT ET LA PREVENTION DES LESIONS ISCHEMIQUES (USE OF TREPROSTINIL TO TREAT AND PREVENT ISCHEMIC LESIONS)
China	101647792	Use of treprostinil to treat and prevent ischemic lesions

Last updated: July 2, 2026

Remodulin (treprostinil) market dynamics and financial trajectory (US, key competitors, and exclusivity/patent-driven risk)

Remodulin (treprostinil) is a parenteral prostacyclin analog with a revenue profile driven by (1) sustained use in pulmonary arterial hypertension (PAH) at specialty centers, (2) competitive pressure from inhaled and oral treprostinil and other prostacyclin pathway agents, and (3) patent and exclusivity timing that governs unit-price stability and generic/biosimilar entry risk. Financial trajectory in the US is dominated by prescription demand for infusion and, secondarily, by transition dynamics between formulation formats and treatment regimens.

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How is Remodulin treprostinil performing financially, and what market forces shape revenue?

Featured snippet: Remodulin’s financial trajectory follows PAH incidence and market share within specialty centers, with pricing and mix impacted by prostacyclin class competition, payer controls, and substitution risk toward inhaled treprostinil (Tyvaso/Tyvaso DPI) and oral prostacyclin pathway drugs.

Key drivers

1. PAH guideline placement and severity mix
   • Remodulin is typically used in patients with more advanced disease or insufficient response to monotherapy, with infusion-based delivery aligned to higher-risk cohorts.
2. Formulation and site-of-care constraints
   • Continuous subcutaneous or intravenous delivery creates adherence and logistical patterns that can slow switching compared with inhaled/oral products.
3. Payer and contracting
   • Specialty pharmacy and institutional contracts shape net pricing; prostacyclin analogs face frequent utilization management, step edits, and prior authorization.
4. Class competition
   • Treprostinil’s direct formulation competition (inhaled and oral treprostinil) overlaps with Remodulin’s target population as clinicians seek lower burden of care.
5. Safety, titration, and intolerance
   • Prostacyclin-related adverse events (e.g., infusion-site pain for SC; systemic vasodilation effects) influence persistency and dose stability.

Revenue sensitivity (what moves the number)

• Patient starts: how quickly new PAH patients are initiated on prostacyclin therapy.
• Persistency: attrition from adverse events or death.
• Dose creep: PAH severity progression can increase total weekly dose and infusion intensity.
• Switching: proportion of patients moving from Remodulin to inhaled/oral treprostinil or vice versa.

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What patents protect Remodulin, and when does exclusivity end?

Featured snippet: Remodulin’s protection is built around treprostinil composition and formulation/delivery-specific IP, plus method-of-use claims tied to PAH. Exclusivity end points and patent expiration determine the window for generic competition risk in the US.

Patent estate structure that drives market behavior

• Drug substance and salts: composition and stable forms.
• Delivery system claims: device pairing, infusion administration features, and formulation characteristics (especially for specific remodulin presentations).
• Method-of-use: PAH patient populations, titration approaches, and administration schedules.

Why this matters for financial trajectory

• While Remodulin has long had label history, newer treprostinil products and updated formulations can change prescriber behavior and net sales mix even before direct generic entry.

(No patent numbers, specific expiration dates, Orange Book listings, or litigation outcomes can be stated here without reliable source-level data in the provided materials.)

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How many competitors does Remodulin face in prostacyclin and treprostinil therapy, and how do they shift market share?

Featured snippet: Remodulin competes across the prostacyclin class and specifically against treprostinil inhalation and oral options, which can capture patient starts and reduce Remodulin share at earlier disease stages.

Competitive set (class and mechanism)

• Direct treprostinil competitors
  • Inhaled treprostinil products (used for PAH; can be favored for reduced burden versus continuous infusion).
  • Oral prostacyclin pathway agents (can substitute for infusion in selected patients when clinically appropriate).
• Other prostacyclin pathway therapies
  • Prostacyclin analogs and prostacyclin receptor agonists used in PAH regimens.
• Combination therapy context
  • Remodulin is often added to background therapy; competitors can also be used in add-on strategies.

Market share shift pathways

1. Earlier line starts
   • Inhaled/oral agents can be chosen before continuous infusion, especially where clinicians try to delay high-burden therapy.
2. Switching driven by tolerance
   • Patients with injection-site pain or catheter complications may shift to alternative prostacyclin delivery.
3. Treatment escalation
   • Failure of less-burdened therapy can still drive escalation to infusion-based prostacyclin, supporting Remodulin’s demand base.

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What is the Orange Book status of Remodulin, and do generic entry risks exist?

Featured snippet: Generic entry risk is gated by whether patents listed in FDA’s Orange Book cover the approved drug and by the remaining term/expiry landscape for each presentation.

Generic entry risk channels

• Paragraph IV challenges
  • If viable unexpired patents exist, Paragraph IV filings can drive litigation and settlement that delays entry.
• Patent carve-outs by presentation
  • Different Remodulin presentations can have different patent coverage and entry readiness.
• Exclusivity layered on top of patents
  • Even with patent expiration, data exclusivity periods and listed-proprietary claims can affect timing.

(Orange Book listing details, specific 505(b)(2) routes, and Paragraph IV history cannot be reliably provided without citation-backed listing data.)

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How do payer dynamics and net price trends impact Remodulin net sales?

Featured snippet: Remodulin net sales track strongly with specialty payer contracting, distribution channels, and utilization management due to high-cost infusion therapy.

Payer contracting and utilization controls

• Prior authorization and step edits
  • Payers increasingly require evidence of PAH diagnosis, prior therapy, and clinical criteria for prostacyclin escalation.
• Center of excellence and specialty pharmacy
  • Infusion therapies are commonly routed through specialty distributors and institutional pharmacies, affecting rebates.
• 340B and hospital mix
  • If dispensed through eligible entities, net pricing can differ meaningfully from standard channels.

How payer pressure affects financial trajectory

• Net-to-gross compression: drives revenue softness even if prescriptions hold.
• Dose management: payer criteria can indirectly reduce dose intensity and persistency.

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What litigation and settlements affect Remodulin’s competitive timeline?

Featured snippet: Patent litigation and settlement agreements determine if and when lower-cost generic substitutes can enter, shaping both pricing stability and unit volume.

Settlement-driven market outcomes

• Delayed entry: keeps Remodulin pricing power intact beyond patent expiration for settlement-protected periods.
• “Design-around” entries: can occur if challengers modify delivery/formulation enough to avoid infringement.
• Injunction risk: can lead to a winner-take-some or loser-take-all outcome depending on claim coverage.

(Litigation docket-level details cannot be stated here without sourced case identifiers and dates.)

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How does Remodulin compare with inhaled and oral treprostinil in clinical and commercial outcomes?

Featured snippet: Inhaled and oral treprostinil can capture patient starts due to lower administration burden; Remodulin can retain higher share among patients needing infusion-level intensity or who fail alternative delivery.

Commercial comparison

• Administration burden
  • Remodulin infusion requires continuous management, which is a cost and adherence factor.
  • Inhaled/oral options typically win on ease of use and lower day-to-day operational complexity.
• Dose and escalation
  • Infusion can deliver rapid and continuous titration which can be clinically attractive in advanced cases.
• Persistency
  • Switching dynamics depend on adverse event profiles and catheter or infusion-site tolerability.

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What are the likely generic launch scenarios for Remodulin, and what barriers exist?

Featured snippet: Generic launch scenarios are primarily limited by remaining patent coverage for treprostinil formulations and administration-related claims, plus product-specific device/infusion system constraints.

Launch scenarios

1. Full generic substitution
   • Requires patent clearance for both drug substance and relevant formulation/delivery claims.
2. Limited substitution by presentation
   • If only certain presentations are cleared, remaining presentations preserve branded sales.
3. Delayed entry via litigation
   • Settlement extends the timeline and reduces near-term sales disruption.

Manufacturing/IP barriers

• Complex infusion workflow
  • Even where the molecule is off-patent, formulation stability, compatibility with infusion systems, and device pairing can be gating factors.
• Label-specific method-of-use claims
  • Clinicians often follow label and accepted practice; if method-of-use patents remain, launch may still face enforcement risk.

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Revenue exposure: how much of Remodulin’s income is at risk from substitution?

Featured snippet: Revenue-at-risk is concentrated in patient-start capture and persistency erosion as inhaled/oral treprostinil expands use earlier in treatment pathways.

Exposure map

• Most exposed segment
  • Newly initiated PAH patients where clinicians prefer less burdensome treprostinil delivery.
• Less exposed segment
  • Advanced disease patients with infusion-managed titration needs and catheter/infusion system stability.

(No market-share or revenue-basis numbers can be provided without underlying company financials, segment reporting, or market sizing sources.)

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Key takeaways

• Remodulin’s financial trajectory is primarily governed by PAH severity mix, persistency, dose escalation, and substitution pressures from inhaled/oral treprostinil.
• Competitive dynamics in prostacyclin pathway therapy can compress net sales even without immediate generic entry, via earlier-line switching.
• Patent and exclusivity remain the structural determinant for generic entry timing, but revenue displacement can occur well before molecule-level exclusivity ends due to delivery-formulation preference shifts.
• Payer contracting and specialty distribution mechanics directly influence net price and can drive revenue softness independent of prescription growth.

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FAQs

1. Does Remodulin lose market share faster to inhaled treprostinil or oral treprostinil?
2. Which PAH patient subgroups are most likely to stay on Remodulin versus switching away?
3. How do net price rebates and specialty pharmacy contracting typically affect Remodulin revenue more than unit volume?
4. What does infusion-site tolerability (SC vs IV) do to Remodulin persistency and sales growth?
5. How do Paragraph IV challenges, if any, translate into settlement-based delays for Remodulin presentation-level entry?

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-07-02).
2. FDA. Drug Approvals and Databases. (Accessed 2026-07-02).
3. Clinical guidelines for pulmonary arterial hypertension and prostacyclin therapy positioning. (Accessed 2026-07-02).