TREPROSTINIL DIOLAMINE - Generic Drug Details

What are the generic sources for treprostinil diolamine and what is the scope of freedom to operate?

Treprostinil diolamine is the generic ingredient in one branded drug marketed by United Therap and is included in one NDA. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil diolamine has fifty-nine patent family members in eight countries.

There are two drug master file entries for treprostinil diolamine. One supplier is listed for this compound.

Summary for TREPROSTINIL DIOLAMINE

International Patents:	59
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	4
Patent Applications:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TREPROSTINIL DIOLAMINE
DailyMed Link:	TREPROSTINIL DIOLAMINE at DailyMed

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

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 TREPROSTINIL DIOLAMINE

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

Sponsor	Phase
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 2
Mardi Gomberg -Maitland	Phase 2
Ohio State University	Phase 2

See all TREPROSTINIL DIOLAMINE clinical trials

Pharmacology for TREPROSTINIL DIOLAMINE

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for TREPROSTINIL DIOLAMINE

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for TREPROSTINIL DIOLAMINE

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 TREPROSTINIL DIOLAMINE

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	203496-001	Dec 20, 2013		RX	Yes	No
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	203496-005	Oct 7, 2016		RX	Yes	No				Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No				Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No			Y

Expired US Patents for TREPROSTINIL DIOLAMINE

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

International Patents for TREPROSTINIL DIOLAMINE

Country	Patent Number	Title	Estimated Expiration
South Korea	101544246
South Korea	101898407
South Korea	20120017058	SOLID FORMULATIONS OF PROSTACYCLIN ANALOGS
South Korea	101614465
Canada	2526534	COMPOSES ET PROCEDES DESTINES A L'ADMINISTRATION D'ANALOGUESDE PROSTACYCLINE (COMPOUNDS AND METHODS FOR DELIVERY OF PROSTACYCLIN ANALOGS)
Japan	5851691

TREPROSTINIL DIOLAMINE Market Analysis and Financial Projection Experimental

Treprostinil Diolamine: Market Dynamics and Financial Trajectory

Introduction to Treprostinil Diolamine

Treprostinil diolamine, a synthetic prostacyclin analog, is a crucial medication in the treatment of pulmonary arterial hypertension (PAH). It works as a vasodilator, reducing blood pressure in the pulmonary artery and improving exercise capacity for patients with PAH.

Market Size and Growth

The treprostinil drugs market, which includes treprostinil diolamine, is projected to experience significant growth. As of 2021, the market size was valued at approximately $1.246 billion and is expected to reach $1.419 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 3.3% during the forecast period of 2024-2032[1].

Leading Regions

North America dominates the treprostinil drugs market, largely due to the high presence of organizations involved in the manufacturing and marketing of treprostinil. This region has generated substantial revenue, with companies like United Therapeutics playing a pivotal role in the market[3].

Key Players

The market is led by prominent pharmaceutical companies such as United Therapeutics, Novartis, and Teva Pharmaceutical Industries Ltd. These companies are actively involved in developing new products, formulations, and collaborations to enhance their market share. For instance, United Therapeutics has been at the forefront with products like Tyvaso, Remodulin, and Orenitram, while Novartis's Sandoz division has launched a fully substitutable generic version of Remodulin[1][3].

Driving Factors

The growth of the treprostinil drugs market is driven by several key factors:

• Rising Prevalence of PAH: The increasing incidence of pulmonary arterial hypertension is a significant driver. As more patients are diagnosed, the demand for effective treatment options like treprostinil diolamine rises[1].
• Advancements in Treatment Options: The development of new formulations and administration methods, such as inhaled and oral routes, enhances patient compliance and treatment efficacy. For example, the FDA approval of Tyvaso DPI, a dry powder formulation of treprostinil, is expected to provide a more convenient method of administration[5].
• Collaborations and Acquisitions: Strategic collaborations between key players, such as the partnership between United Therapeutics and MannKind Corporation for the development of a dry powder formulation of treprostinil, are driving market growth[3].

Dosage Forms and Administration

Treprostinil diolamine is available in various dosage forms, each catering to different patient needs:

• Intravenous (Remodulin): Administered through a continuous infusion, this form is used for severe PAH cases.
• Inhaled (Tyvaso): Delivered via an inhaler, this form is more convenient and improves exercise capacity.
• Oral (Orenitram): Extended-release tablets that delay the progression of PAH[3][4].

Market Dynamics

Competitive Landscape

The competitive landscape of the treprostinil drugs market is characterized by intense competition among key players. Companies are focusing on developing new products and formulations to stay ahead. The launch of generic versions, such as Sandoz's Treprostinil Injection, has also impacted the market dynamics, offering patients more affordable treatment options[3].

Regulatory Approvals

Regulatory approvals play a critical role in the market trajectory. The FDA's acceptance of the New Drug Application (NDA) for Tyvaso DPI, for instance, is a significant step towards providing patients with more convenient treatment options. Such approvals not only expand the market but also validate the safety and efficacy of new formulations[5].

Clinical Studies and Trials

Ongoing clinical studies and trials are essential for the market's growth. For example, United Therapeutics is enrolling patients in clinical studies for Tyvaso to treat conditions like PH-COPD and idiopathic pulmonary fibrosis (IPF), which could significantly expand the addressable patient population[2].

Financial Performance

The financial performance of treprostinil diolamine and related products is robust:

• Revenue Generation: In 2021, United Therapeutics generated significant revenue from its treprostinil-based products. Tyvaso contributed $607.5 million, Orenitram contributed $306.1 million, and Remodulin contributed $513.7 million, with $90.2 million coming from non-U.S. sales[2].
• Impact of Generics: The introduction of generic versions, such as Sandoz's Treprostinil Injection, has affected the revenue of branded products. However, the overall market growth is expected to mitigate this impact[2].

Regional Insights

North America

North America remains the leading region due to the strong presence of pharmaceutical companies and a well-established healthcare infrastructure. The region has seen significant revenue generation from treprostinil-based products[3].

Other Regions

Other regions, including Europe, Asia Pacific, and Latin America, are also growing, albeit at a slower pace. These regions offer potential for future growth as healthcare infrastructure improves and awareness about PAH treatments increases[4].

Future Outlook

The future outlook for the treprostinil drugs market is promising:

• New Indications: The potential for new indications, such as treating patients with PH-ILD, PH-COPD, and IPF, is expected to expand the market significantly[2].
• Technological Advancements: The development of new formulations and delivery systems, like dry powder inhalers, will continue to enhance patient compliance and treatment efficacy[5].

Key Takeaways

• The treprostinil drugs market is expected to grow at a CAGR of 3.3% from 2021 to 2032.
• North America is the leading region in the market.
• Key players include United Therapeutics, Novartis, and Teva Pharmaceutical Industries Ltd.
• Rising prevalence of PAH and advancements in treatment options are driving market growth.
• Various dosage forms, including intravenous, inhaled, and oral, cater to different patient needs.
• Regulatory approvals and clinical studies are crucial for market expansion.

FAQs

What is the expected CAGR of the treprostinil drugs market by 2032?

The treprostinil drugs market is expected to exhibit a CAGR of 3.3% from 2021 to 2032[1].

Which region dominates the treprostinil drugs market?

North America dominates the treprostinil drugs market due to the high presence of organizations involved in treprostinil manufacturing and marketing[3].

What are the key dosage forms of treprostinil diolamine?

Treprostinil diolamine is available in intravenous (Remodulin), inhaled (Tyvaso), and oral (Orenitram) forms[3][4].

How do generic versions impact the market?

Generic versions, such as Sandoz's Treprostinil Injection, offer more affordable treatment options but can reduce the revenue of branded products[2].

What are the potential new indications for treprostinil diolamine?

Potential new indications include treating patients with PH-ILD, PH-COPD, and IPF, which could significantly expand the addressable patient population[2].

Sources

1. Business Research Insights: Treprostinil Drugs Market Size, Share, Growth, Trends | 2032
2. Annual Reports: Liquidia PAH Annual Report 2021
3. Coherent Market Insights: Treprostinil Drugs Market - Share, Size and Industry Analysis
4. iHealthcare Analyst: Pulmonary Arterial Hypertension Market and Forecast 2024-2031
5. PR Newswire: United Therapeutics Announces FDA Acceptance of Tyvaso DPI New Drug Application for Priority Review