TRACLEER Drug Patent Profile

When do Tracleer patents expire, and when can generic versions of Tracleer launch?

Tracleer is a drug marketed by Actelion and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in twenty-three countries.

The generic ingredient in TRACLEER is bosentan. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bosentan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tracleer

A generic version of TRACLEER was approved as bosentan by SUN PHARM on April 26^th, 2019.

Summary for TRACLEER

International Patents:	28
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	43
Patent Applications:	4,548
Drug Prices:	Drug price information for TRACLEER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRACLEER
What excipients (inactive ingredients) are in TRACLEER?	TRACLEER excipients list
DailyMed Link:	TRACLEER at DailyMed

See drug prices for TRACLEER

Recent Clinical Trials for TRACLEER

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
City of Hope Medical Center	Phase 1
University of Mississippi Medical Center	Early Phase 1

See all TRACLEER clinical trials

Pharmacology for TRACLEER

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A Inducers Endothelin Receptor Antagonists

Paragraph IV (Patent) Challenges for TRACLEER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRACLEER	for Oral Suspension	bosentan	32 mg	209279	1	2019-02-08

US Patents and Regulatory Information for TRACLEER

TRACLEER is protected by two US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017		RX	Yes	Yes			Y
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	Nov 20, 2001	AB	RX	Yes	No
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017		RX	Yes	Yes			Y
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017		RX	Yes	Yes

Expired US Patents for TRACLEER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	Nov 20, 2001
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001

EU/EMA Drug Approvals for TRACLEER

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Tracleer	bosentan	EMEA/H/C/000401 Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in:, , , Primary (idiopathic and familial) PAH;, PAH secondary to scleroderma without significant interstitial pulmonary disease;, PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology., , , Some improvements have also been shown in patients with PAH WHO functional class II., , Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.,	Authorised	no	no	no	2002-05-14

International Patents for TRACLEER

When does loss-of-exclusivity occur for TRACLEER?

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

Australia

Austria

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Germany

Hong Kong

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

Slovenia

South Africa

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 TRACLEER around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	9204126
Finland	112216
Austria	197044
Ireland	921920

Supplementary Protection Certificates for TRACLEER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0526708	C300097	Netherlands		PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
0526708	0290017-3	Sweden		PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
0526708	CA 2002 00026	Denmark
0526708	300097	Netherlands

TRACLEER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tracleer (Bosentan)

Introduction

Tracleer, also known as bosentan, is a dual endothelin receptor antagonist developed by Actelion Ltd., now part of Johnson & Johnson. It is primarily used to treat pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs. Here, we will delve into the market dynamics and financial trajectory of Tracleer.

Historical Sales Performance

Tracleer has been a cornerstone in Actelion's product portfolio since its market introduction. In 2011, Tracleer continued to show strong sales growth, with a 5% increase in local currencies and an 8% increase in units sold, marking 10 years of consistent sales growth[2].

Regional Market Performance

The sales of Tracleer have been driven by different factors across various regions. In the United States, despite a competitive shift due to changes in a competitor's product label and risk evaluation and mitigation strategy (REMS) obligations, Tracleer maintained its market presence. However, there was a gradual decline in new prescriptions for Tracleer in the US. Outside the US, particularly in Europe and Australia, Tracleer sales were boosted by the conversion of patients from sitaxentan, which was withdrawn in early 2011[2].

Competitive Landscape

The PAH market is highly competitive, with several key players. Tracleer competes with other endothelin receptor antagonists like ambrisentan (Letairis) and macitentan (Opsumit), as well as other drug classes such as PDE-5 inhibitors and prostacyclin analogs. Despite this competition, Tracleer has maintained its position due to its proven efficacy in improving patients' functional class, a key target in PAH treatment[2][4].

Financial Impact

In 2011, Tracleer generated CHF 1,522.1 million in sales, which was a significant portion of Actelion's total product sales of CHF 1,713.0 million. This revenue was crucial for Actelion's financial health, contributing to the company's core earnings of CHF 437.5 million for the year[2].

Market Size and Growth

The global PAH market, within which Tracleer operates, is expected to grow to $6.7 billion by 2031, with a compound annual growth rate (CAGR) of 2.3% over the forecast period. This growth is driven by increasing prevalence and incidence of PAH, unmet medical needs, and the premium pricing of drugs in this category[4].

Key Factors Affecting Market Dynamics

Several factors influence the market dynamics of Tracleer:

Patient Demand

Patient demand has been a primary driver of Tracleer sales. The drug's efficacy in improving functional class and delaying clinical worsening in PAH patients has maintained its popularity among prescribers[2][5].

Competitive Dynamics

Changes in competitor product labels and REMS obligations have impacted Tracleer's market share, particularly in the US. However, outside the US, Tracleer has continued to grow due to the conversion of patients from other withdrawn drugs[2].

Regulatory Environment

Regulatory approvals and changes in healthcare policies can significantly affect the market dynamics. For instance, the withdrawal of sitaxentan in 2011 led to an increase in Tracleer sales in certain regions[2].

Economic Factors

Economic conditions, including pricing pressures and macro-economic challenges, have influenced Actelion's overall financial performance. Despite these challenges, the company has managed to maintain strong sales growth for Tracleer[2].

Technological and Therapeutic Advancements

The PAH treatment landscape is evolving with new therapeutic approaches. For example, translational therapies targeting the NO-sGC-cGMP pathway and the use of prostacyclin analogs are gaining traction. However, Tracleer remains a significant player due to its established efficacy and safety profile[4].

Future Outlook

Given the expected growth of the PAH market, Tracleer is likely to continue playing a crucial role. However, the introduction of new drugs and therapies, such as Winrevair (sotatercept) by Merck, may pose future challenges. Actelion's strategy to focus on optimizing the earnings power of its business and preparing for new products will be critical in maintaining Tracleer's market position[2][4].

SWOT Analysis

Strengths

• Proven efficacy in improving functional class in PAH patients.
• Wide global availability and strong market presence.
• Established brand with a long history of sales growth.

Weaknesses

• Increasing competition from new and existing drugs.
• Dependence on a single product for significant revenue.
• Potential decline in market share due to changes in competitor product labels and REMS obligations.

Opportunities

• Growing PAH market with increasing prevalence and incidence.
• Potential for expansion into emerging markets.
• Opportunities for new indications and therapeutic uses.

Threats

• Competitive pressures from other drug classes and new therapies.
• Regulatory changes and pricing pressures.
• Economic instability and global health crises[1][2][4].

Key Takeaways

• Tracleer has been a cornerstone in Actelion's product portfolio with consistent sales growth.
• The drug competes in a highly competitive PAH market but maintains its position due to proven efficacy.
• The global PAH market is expected to grow, driven by increasing prevalence and premium pricing of drugs.
• Future success will depend on Actelion's ability to optimize earnings and adapt to new market dynamics.

FAQs

What is Tracleer used for?

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

How has Tracleer performed in the market?

Tracleer has shown strong sales growth since its market introduction, with a 5% increase in local currencies and an 8% increase in units sold in 2011, marking 10 years of consistent growth.

What are the key factors affecting Tracleer's market dynamics?

Key factors include patient demand, competitive dynamics, regulatory environment, and economic factors such as pricing pressures and macro-economic challenges.

How does Tracleer compete in the PAH market?

Tracleer competes with other endothelin receptor antagonists and different drug classes but maintains its position due to its proven efficacy in improving patients' functional class.

What is the future outlook for Tracleer?

Given the expected growth of the PAH market, Tracleer is likely to continue playing a crucial role, but it will need to adapt to new market dynamics and competitive pressures from new therapies.

Sources

1. Cognitivemarketresearch.com: Tracleer bosentan Market Report 2024 (Global Edition)
2. Fiercebiotech.com: Actelion announces Full Year 2011 financial results
3. Q4cdn.com: 2022-annual-report.pdf
4. Ihealthcareanalyst.com: Global Pulmonary Arterial Hypertension Market $6.7 Billion by 2031
5. Biospace.com: Actelion Ltd. Release: Successful Study With Tracleer(R) In Patients With Mildly Symptomatic Pulmonary Arterial Hypertension