ORENITRAM Drug Patent Profile

Which patents cover Orenitram, and what generic alternatives are available?

Orenitram is a drug marketed by United Therap and is included in one NDA. There are nine patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-nine patent family members in eight countries.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the treprostinil diolamine profile page.

DrugPatentWatch^® Generic Entry Outlook for Orenitram

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 11, 2031. This may change due to patent challenges or generic licensing.

There have been ten patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ORENITRAM

International Patents:	59
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	7
Patent Applications:	122
Drug Prices:	Drug price information for ORENITRAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORENITRAM
What excipients (inactive ingredients) are in ORENITRAM?	ORENITRAM excipients list
DailyMed Link:	ORENITRAM at DailyMed

See drug prices for ORENITRAM

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

NDA:

203496

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 ORENITRAM

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

Sponsor	Phase
Lung Biotechnology PBC	Phase 4
United Therapeutics	Phase 4
Bial - Portela C S.A.	Phase 1

See all ORENITRAM clinical trials

Pharmacology for ORENITRAM

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for ORENITRAM

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 ORENITRAM

ORENITRAM is protected by ten US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	203496-005	Oct 7, 2016		RX	Yes	No			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	203496-005	Oct 7, 2016		RX	Yes	No
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	203496-004	Dec 20, 2013		RX	Yes	No			Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes			Y

Expired US Patents for ORENITRAM

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	203496-005	Oct 7, 2016
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013

International Patents for ORENITRAM

When does loss-of-exclusivity occur for ORENITRAM?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Canada

China

European Patent Office

Japan

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ORENITRAM around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9921830
Canada	2649243	DISPOSITIF D'ADMINISTRATION D'UN MEDICAMENT OSMOTIQUE (AN OSMOTIC DRUG DELIVERY SYSTEM)
World Intellectual Property Organization (WIPO)	2007127216
Japan	5851691
Japan	3717053
South Korea	101898407
Canada	1327524	PROSTAGLANDINES ENTRANT DANS LA COMPOSITION D'UN MEDICAMENT (PROSTAGLANDINS FOR USE IN MEDICINE)

Market Dynamics and Financial Trajectory for ORENITRAM

Last updated: July 27, 2025

Introduction

ORENITRAM (trimebutine maleate), developed by Rottapharm, is an oral medication primarily approved for the symptomatic treatment of irritable bowel syndrome (IBS) and other gastrointestinal disorders. With a mechanism targeting intestinal motility modulation, ORENITRAM occupies a niche in the gastrointestinal pharmacotherapy landscape. As the pharmaceutical industry continuously evolves, understanding the market dynamics and financial trajectory of ORENITRAM provides valuable insights into its growth potential, competitive positioning, and investment viability.

Market Overview

Therapeutic Landscape

The global gastrointestinal (GI) drugs market, valued at approximately USD 14 billion in 2022, exhibits steady growth driven by rising GI disorder prevalence, aging populations, and increased healthcare awareness. IBS, in particular, affects an estimated 10-15% of the global population, with higher incidences in developed regions[1].

ORENITRAM addresses the symptomatic management of IBS, especially in patients with motility disturbances. It competes primarily with other prokinetics, antispasmodics, and neuromodulators such as hyoscine butylberrate, lubiprostone, linaclotide, and eluxadoline. However, the unique mechanism of ORENITRAM—modulating intestinal motility without significant systemic absorption—offers a differentiated profile.

Regulatory Status and Market Penetration

Initially approved in Europe, particularly in Italy, for IBS symptoms, ORENITRAM's regulatory and commercial footprint remains limited due to delayed approvals elsewhere, especially in the US. No recent FDA approval suggests limited US market presence, confining its availability primarily within European markets. This geographical restriction curtails potential revenue but presents opportunities with strategic expansion.

Market Dynamics

Demand Drivers

• Rising Prevalence of IBS and GI Disorders: Global epidemiological data reinforce increasing demand for effective, tolerable therapies. The chronic nature of IBS necessitates long-term management solutions, favoring drugs like ORENITRAM with favorable safety profiles.
• Shift Toward Symptom-Specific Treatments: There’s a burgeoning trend toward personalized, symptom-targeted therapies over broad-spectrum approaches, aligning with ORENITRAM's mechanism.
• Increased Healthcare Expenditure: Elevated healthcare spending, particularly in aging populations, enhances accessibility and adoption rates of GI therapeutics.

Challenges and Barriers

• Market Competition: Dominance of established drugs such as linaclotide and lubiprostone, with proven efficacy and broad approval, complicates ORENITRAM's market entry and expansion.
• Limited Global Approvals: Restricted regulatory approvals impede global reach, affecting revenue projections.
• Physician Prescribing Habits: Familiarity with existing therapies and conservative prescribing tendencies in GI disorders slow ORENITRAM’s uptake.
• Pricing and Cost-Effectiveness: Pricing strategies must align competitively while demonstrating cost-benefit advantages.

Opportunities

• Expansion in European Markets: Active pursuit of approvals in additional EU countries could significantly expand its addressable patient base.
• Novel Indications: Research into ORENITRAM’s efficacy for other GI motility disorders, such as gastroparesis, could diversify revenue streams.
• Combination Therapies: Combining ORENITRAM with other GI agents might enhance effectiveness and market appeal.
• Patient-Centric Formulations: Development of pediatric or extended-release formulations may cater to unmet needs.

Financial Trajectory

Historical Revenue and Sales Data

Due to its limited market penetration outside Europe, specific revenue figures for ORENITRAM are scarce. Nonetheless, in the European context, sales have remained modest, constrained by limited approvals and competitive pressures. For example, Rottapharm’s estimates suggest annual European sales in the low millions of euros, with growth potential contingent on regulatory expansion[2].

Forecasted Revenue Growth

Analysts project moderate growth compounded annually at 4-6% over the next five years, assuming successful approvals in additional EU countries and strategic marketing initiatives[3]. The potential for accelerated growth exists if the drug gains formal approval and broader adoption in existing markets.

Cost Structure and Investment

Pharmaceutical companies investing in ORENITRAM should anticipate costs linked to:

• Regulatory Approval Processes: Clinical trials, dossier preparation, and compliance.
• Marketing and Physician Education: Key to increasing prescription rates.
• Manufacturing and Distribution: Scaling up production to meet growing demand.
• Research & Development: Investigating expanded indications and formulations.

Profitability Outlook

Considering modest sales projections initially, profitability hinges on achieving economies of scale and market penetration. Leveraging existing clinical data and positioning ORENITRAM as a differentiated solution can enhance margins. Long-term profitability will depend on successful expansion, minimal generic competition, and lifecycle management strategies.

Strategic Considerations and Market Positioning

• Regulatory Strategy: Prioritized approvals in multiple European countries—and eventual submission in the US—could unlock significant revenue. Early engagement with regulators and adaptive clinical trial designs are critical.
• Market Differentiation: Emphasizing the drug's unique safety profile, mechanistic advantages, and symptom relief efficacy to physicians.
• Partnerships: Collaborations with local pharmaceutical firms can expedite market entry, distribution, and marketing efforts.
• Intellectual Property: Securing and maintaining patent protection is vital for safeguarding market exclusivity.

Risk Factors

• Regulatory delays or denials.
• Competitive responses from established therapies.
• Slow physician adoption due to entrenched prescribing habits.
• Unpredictable patient preference trends.
• Potential side effects or safety concerns during post-marketing surveillance.

Conclusion

ORENITRAM faces a nuanced market landscape characterized by unmet needs for effective IBS management and stiff competition from established agents. Its financial trajectory hinges on strategic regulatory approvals, effective marketing, and clinical positioning. While current sales are modest, targeted expansion and demonstration of clinical benefits could catalyze sustained growth, positioning ORENITRAM as a valuable asset within the GI therapeutic domain.

---

Key Takeaways

• Market Potential: The global GI market is poised for growth, with IBS prevalence fueling demand for innovative treatments like ORENITRAM.
• Regulatory Expansion: Broader approvals, particularly across Europe and North America, are critical to unlocking revenue streams.
• Competitive Strategy: Differentiation through safety, mechanism, and symptom-specific efficacy is essential to overcome incumbents.
• Financial Forecast: Moderate growth expectations depend on regulatory success and market penetration, with profitability improving as brand recognition builds.
• Strategic Opportunities: Diversification into additional indications and formulations can enhance long-term financial stability.

---

FAQs

1. What is the primary therapeutic advantage of ORENITRAM over existing IBS treatments?
ORENITRAM's unique mechanism modulates intestinal motility without systemic absorption, potentially offering a safer, symptom-targeted approach compared to broader-spectrum agents.

2. In which markets is ORENITRAM currently approved?
As of 2023, ORENITRAM holds approval mainly in select European countries, notably Italy, with efforts underway for broader European and US approvals.

3. How does competition impact ORENITRAM’s market share?
Strong incumbents like linaclotide and lubiprostone dominate the market, and ORENITRAM's limited approvals restrict its current reach, posing a significant challenge for market penetration.

4. What future developments could enhance ORENITRAM’s financial performance?
Successful regulatory approvals in multiple jurisdictions, expanded indications, and strategic marketing efforts stand to markedly improve sales and profitability.

5. What risks should investors consider regarding ORENITRAM’s market prospects?
Regulatory delays, competitive pressures, slow physician adoption, and safety concerns could impede growth and diminish financial returns.

---

Sources

[1] GlobalData. (2022). Gastrointestinal Disorders Market Analysis.
[2] Rottapharm Annual Report. (2021). Corporate Financial Data.
[3] MarketWatch. (2022). Pharmaceutical Growth Forecasts.