TREPROSTINIL - Generic Drug Details

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

Treprostinil is the generic ingredient in five branded drugs marketed by United Therap, Alembic Global, Dr Reddys, Endo Operations, Sandoz, and Teva Pharms Usa, and is included in ten NDAs. There are twenty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil has one hundred and eighty-nine patent family members in twenty-two countries.

There are nineteen drug master file entries for treprostinil. Six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for TREPROSTINIL

International Patents:	189
US Patents:	29
Tradenames:	5
Applicants:	6
NDAs:	10
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	105
Patent Applications:	2,516
Drug Prices:	Drug price trends for TREPROSTINIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TREPROSTINIL
What excipients (inactive ingredients) are in TREPROSTINIL?	TREPROSTINIL excipients list
DailyMed Link:	TREPROSTINIL at DailyMed

See drug prices for TREPROSTINIL

Recent Clinical Trials for TREPROSTINIL

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

Sponsor	Phase
Insmed Incorporated	Phase 2/Phase 3
Mayo Clinic	Phase 2
Mardi Gomberg -Maitland	Phase 2

See all TREPROSTINIL clinical trials

Generic filers with tentative approvals for TREPROSTINIL

Applicant	Application No.	Strength	Dosage Form
		0.4MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
		0.2MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
		0.1MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for TREPROSTINIL

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for TREPROSTINIL

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

Paragraph IV (Patent) Challenges for TREPROSTINIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TYVASO	Inhalation Solution	treprostinil	0.6 mg/mL, 2.9 mL ampules	022387	1	2015-04-13
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 TREPROSTINIL

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	10,076,505		Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes	9,593,066			Y
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	AP	RX	Yes	Yes	9,199,908
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No	8,747,897		Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022		RX	Yes	No	10,421,729		Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-001	May 23, 2022		RX	Yes	No

Expired US Patents for TREPROSTINIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	9,199,908
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	9,199,908
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009	6,765,117
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	10,076,505
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-002	May 21, 2002	9,199,908
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	10,695,308

EU/EMA Drug Approvals for TREPROSTINIL

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

International Patents for TREPROSTINIL

Country	Patent Number	Title	Estimated Expiration
Japan	5851691
Singapore	10201708090T	MICROCRYSTALLINE DIKETOPIPERAZINE COMPOSITIONS AND METHODS
Japan	2012162539	COMPOUND AND METHOD FOR DELIVERY OF PROSTACYCLIN ANALOG
China	101780092	Compounds and methods for delivery of prostacyclin analogs
South Korea	101161889
Spain	2754388

TREPROSTINIL Market Analysis and Financial Projection Experimental

Treprostinil Drugs Market: Dynamics and Financial Trajectory

Market Overview

The treprostinil drugs market is experiencing significant growth, driven by the increasing prevalence of pulmonary arterial hypertension (PAH) and related conditions. Treprostinil, a synthetic prostacyclin, is prescribed for its efficacy in improving exercise capacity, slowing disease progression, and prolonging survival in PAH patients[1][4].

Increasing Prevalence of PAH

The primary driver of the treprostinil drugs market is the rising incidence of PAH, a rare and progressive disorder characterized by high blood pressure in the pulmonary arteries. As the global population ages and the prevalence of risk factors for PAH increases, the demand for effective treatments like treprostinil has surged dramatically[1].

Proven Efficacy and Treatment Options

Treprostinil has proven its efficacy in improving patient outcomes, making it a cornerstone in PAH treatment. It is available in various formulations, including oral (Orenitram), inhalation (Tyvaso), and infusion (Remodulin), allowing for tailored treatment approaches[4].

Regional Market Dynamics

North America

North America, particularly the United States, dominates the treprostinil drugs market due to the presence of well-established healthcare infrastructure, advanced diagnostic capabilities, and a high prevalence of PAH. The availability of reimbursement options, such as Medicare and private insurance, facilitates patient access to treprostinil therapies. Key players like United Therapeutics are based in this region, contributing to robust research and development efforts[1][4].

Europe

Europe is another significant market, with countries like Germany, France, and the United Kingdom contributing substantially. The region's focus on rare disease research and specialized healthcare facilities for PAH management have driven market growth[1].

Asia-Pacific

The Asia-Pacific region presents a substantial growth opportunity, driven by improving healthcare infrastructure, increasing awareness of PAH, and rising disposable incomes. Countries like China, Japan, and India are expected to see a surge in demand for treprostinil therapies[1].

Latin America and Middle East & Africa

These regions currently have smaller markets but are anticipated to grow as awareness of PAH increases and access to specialized healthcare services improves[1].

Financial Performance and Growth

Revenue Growth

The treprostinil drugs market has witnessed significant revenue growth. For instance, United Therapeutics reported a 16% year-over-year increase in total revenues in the third quarter of 2022, reaching $516 million. The growth in Tyvaso revenues was particularly notable, driven by the launch of Tyvaso DPI and the expansion of its label to include the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD)[2].

Key Products

• Tyvaso: Achieved a $1 billion annual run rate in 2022, with significant growth driven by the launch of Tyvaso DPI and label expansion[2].
• Remodulin: Despite a slight decline in revenues in 2022, it remains a crucial product in the treprostinil portfolio[2].
• Orenitram: Extended-release treprostinil tablets approved by the FDA in 2019, contributing to market growth[4].

Competitive Landscape

The treprostinil drugs market is highly concentrated, with a few key players dominating the landscape. United Therapeutics is a major player, along with other companies like Novartis and Teva Pharmaceutical Industries Ltd. These companies are focused on developing new products and formulations to enhance their market share. For example, Sandoz launched a generic version of Remodulin in 2019, gaining market exclusivity for 180 days[4].

Research and Development

Ongoing research and development efforts are a key driver of the market. Innovations include novel formulations and delivery methods such as long-acting or extended-release formulations, transdermal patches, and implantable devices. These advancements aim to improve patient convenience, adherence, and overall treatment outcomes. Collaborations, such as the one between United Therapeutics and MannKind Corporation for a dry powder formulation of treprostinil, are also significant[1][4].

Challenges and Opportunities

Pricing and Reimbursement

High costs associated with treprostinil therapy and reimbursement challenges, particularly in regions with limited healthcare resources, pose significant hurdles. Addressing these through innovative pricing strategies, patient assistance programs, and collaborations with payers and regulatory bodies is crucial for ensuring broad patient access[1].

Generic and Biosimilar Entry

The potential entry of generic or biosimilar versions of treprostinil could impact the competitive dynamics, offering more affordable options but also potentially leading to pricing pressures for established players[1].

Future Outlook

The treprostinil drugs market is poised for continued growth and innovation. The increasing prevalence of PAH, ongoing research and development, and the pursuit of more convenient and effective treatment options are driving forces. The market is expected to witness exponential growth at a significant CAGR during the forecast period from 2024 to 2033[1].

Market Size and Growth Projections

The pulmonary arterial hypertension drugs market, which includes treprostinil, is projected to reach USD 11.6 billion by 2032, growing at a CAGR of 4.6% during 2024-2032. This growth is driven by the expanding geriatric population, introduction of orphan drugs, and technologically advanced devices[3].

Key Takeaways

• The treprostinil drugs market is driven by the increasing prevalence of PAH and related conditions.
• North America and Europe are the leading markets due to advanced healthcare infrastructure and high prevalence of PAH.
• Various formulations of treprostinil, including oral, inhalation, and infusion, cater to different patient needs.
• Ongoing research and development focus on novel formulations and delivery methods.
• Pricing and reimbursement challenges need to be addressed to ensure broad patient access.
• The market is expected to grow significantly, driven by demographic and technological factors.

FAQs

What is the primary driver of the treprostinil drugs market?

The primary driver is the increasing prevalence of pulmonary arterial hypertension (PAH) and related conditions worldwide.

Which regions dominate the treprostinil drugs market?

North America and Europe are the leading markets, driven by well-established healthcare infrastructure and a high prevalence of PAH.

What are the different formulations of treprostinil available?

Treprostinil is available in oral (Orenitram), inhalation (Tyvaso), and infusion (Remodulin) formulations.

What are the challenges facing the treprostinil drugs market?

High costs associated with treprostinil therapy and reimbursement challenges are significant hurdles, along with the potential entry of generic or biosimilar versions.

What is the projected growth of the pulmonary arterial hypertension drugs market?

The market is expected to reach USD 11.6 billion by 2032, growing at a CAGR of 4.6% during 2024-2032.

Sources

1. DataHorizon Research: Treprostinil Drugs Market Size, Share & Forecast 2033.
2. United Therapeutics Corporation: Reports Third Quarter 2022 Financial Results.
3. Biospace: Pulmonary Arterial Hypertension Drugs Market Size to Reach USD 11.6 Billion by 2032.
4. Coherent Market Insights: Treprostinil Drugs Market - Share, Size and Industry Analysis.