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ORENITRAM Drug Patent Profile

Which patents cover Orenitram, and when can generic versions of Orenitram launch?

Orenitram is a drug marketed by United Therap and is included in one NDA. There are fourteen 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 eight 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:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	7
Patent Applications:	73
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 fifteen 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	203496-003	Dec 20, 2013		RX	Yes	Yes			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	203496-004	Dec 20, 2013		RX	Yes	No			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	203496-003	Dec 20, 2013		RX	Yes	Yes

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	203496-002	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	203496-001	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	203496-004	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016

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
Japan	2012162539	COMPOUND AND METHOD FOR DELIVERY OF PROSTACYCLIN ANALOG
Japan	5851691
Canada	2760499	COMPOSITIONS SOLIDES A BASE D'ANALOGUES DE PROSTACYCLINE (SOLID FORMULATIONS OF PROSTACYCLIN ANALOGS)
World Intellectual Property Organization (WIPO)	2009078965
South Korea	101555455
United Kingdom	8824187

ORENITRAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Orenitram

Introduction to Orenitram

Orenitram, developed by United Therapeutics Corporation, is a prescription medicine used to treat pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs. It is an oral prostacyclin-class therapy, specifically an extended-release tablet formulation of treprostinil.

Clinical Efficacy and Market Impact

Delay in Disease Progression

Orenitram has demonstrated significant clinical efficacy in delaying disease progression in PAH patients. The FREEDOM-EV study showed a 61% reduced risk of disease progression and a 25% decreased risk of clinical worsening compared to placebo[1][3].

Improvement in Key Prognostic Measures

The drug has improved key prognostic measures such as the six-minute walk distance (6MWD), N-terminal pro b-type natriuretic peptide (NT-proBNP) levels, and World Health Organization Functional Class (WHO FC). Patients on Orenitram showed an average 6MWD improvement of 22 meters at week 48 and a 41% reduction in NT-proBNP levels at week 36 compared to placebo[1][3].

Hemodynamic Benefits

Orenitram significantly improved hemodynamic parameters, including a 20% reduction in pulmonary vascular resistance, a 19% increase in cardiac output, and a 17% increase in cardiac index at a median week 24 dose[3].

Financial Performance

Revenue Growth

Orenitram has contributed to the strong financial performance of United Therapeutics. In the second quarter of 2024, the company reported total revenues growing 20% year-over-year to $714.9 million. While the specific revenue figures for Orenitram were not highlighted in this period, the growth in Orenitram revenues has been driven by an increase in quantities sold and, to a lesser extent, a price increase[2].

Historical Revenue Trends

In the third quarter of 2022, Orenitram revenues saw a modest increase of 3% to $87.5 million compared to the same period in 2021. This growth, although not as robust as other products like Tyvaso, indicates a stable market presence for Orenitram[5].

Market Position and Competitiveness

Comparative Analysis

A retrospective database analysis comparing Orenitram with selexipag, another PAH treatment, showed that Orenitram was associated with significantly lower pharmacy costs and overall healthcare costs. This analysis indicated that treatment with selexipag was associated with 67% higher PAH-related patient healthcare costs compared to Orenitram, despite similar adherence and hospitalization rates[3].

Unique Selling Proposition

Orenitram is the only oral prostacyclin-class therapy that has demonstrated improvements in WHO FC, making it a unique offering in the PAH treatment market. The drug's ability to delay disease progression, improve hemodynamic parameters, and reduce healthcare costs strengthens its value proposition to physicians, payers, and patients[1][3].

Patient and Physician Confidence

Clinical Confidence

The additional data from the FREEDOM-EV study, including improvements in risk status and hemodynamic parameters, have bolstered physician confidence in Orenitram. These findings have resonated well with PAH providers and payers, further solidifying Orenitram's position in the treatment landscape[3].

Patient Outcomes

The durable improvement in clinically relevant components of risk, such as 6MWD, NT-proBNP, and WHO FC, translates into better long-term outcomes for patients. This has been a key factor in patient and physician preference for Orenitram[1][3].

Adverse Events and Tolerability

Safety Profile

While Orenitram has shown a favorable efficacy profile, it is not without adverse events. The drug has been associated with adverse reactions, with 19% of patients treated with Orenitram discontinuing treatment due to an adverse event in Study 4. However, only 4% discontinued therapy for an adverse reaction, which is relatively low compared to other treatments[4].

Future Outlook

Market Expansion

The implementation of the Part D redesign under the Inflation Reduction Act (IRA) has driven increased commercial utilization of Orenitram, contributing to its revenue growth. This trend is expected to continue, further expanding the market for Orenitram[2].

Financial Projections

Given the strong financial results of United Therapeutics and the specific growth drivers for Orenitram, the drug is likely to continue contributing significantly to the company's revenue. The $1 billion accelerated share repurchase program announced by United Therapeutics also indicates a positive outlook on future financial performance[2].

Key Takeaways

• Clinical Efficacy: Orenitram delays disease progression, improves key prognostic measures, and enhances hemodynamic parameters in PAH patients.
• Financial Performance: The drug has contributed to United Therapeutics' revenue growth, driven by increased quantities sold and price adjustments.
• Market Position: Orenitram stands out as the only oral prostacyclin-class therapy improving WHO FC, with lower healthcare costs compared to competitors.
• Patient and Physician Confidence: The drug's benefits have increased confidence among physicians and improved patient outcomes.
• Future Outlook: Orenitram is expected to continue growing due to favorable market conditions and regulatory changes.

FAQs

Q: What is Orenitram used for?

Orenitram is used to treat pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs.

Q: How does Orenitram delay disease progression in PAH patients?

Orenitram delays disease progression by reducing the risk of clinical worsening and improving key prognostic measures such as 6MWD, NT-proBNP, and WHO FC.

Q: What are the hemodynamic benefits of Orenitram?

Orenitram significantly improves hemodynamic parameters, including a 20% reduction in pulmonary vascular resistance, a 19% increase in cardiac output, and a 17% increase in cardiac index.

Q: How does Orenitram compare to other PAH treatments in terms of healthcare costs?

Orenitram is associated with significantly lower pharmacy costs and overall healthcare costs compared to other treatments like selexipag.

Q: What are the common adverse events associated with Orenitram?

Common adverse events include those that led to 19% of patients discontinuing treatment, although only 4% discontinued due to an adverse reaction.

Sources

1. Orenitram Clinical Efficacy | FREEDOM EV - Orenitram Is Proven to Delay Disease Progression[1]
2. United Therapeutics Corporation Reports Second Quarter 2024 Financial Results - United Therapeutics Corporation[2]
3. United Therapeutics Announces Additional Results From FREEDOM-EV Study - PR Newswire[3]
4. Orenitram Doctor Discussion Guide - Orenitram[4]
5. United Therapeutics Corporation Reports Third Quarter 2022 Financial Results - United Therapeutics Corporation[5]