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:	85
Clinical Trials:	44
Patent Applications:	5,801
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
Humanis Saglık Anonim Sirketi	PHASE1
National Cancer Institute (NCI)	Phase 1
City of Hope Medical Center	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.

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	AB	RX	Yes	Yes	8,309,126		Y
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001	AB	RX	Yes	Yes
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017	AB	RX	Yes	Yes	7,959,945		Y
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	Nov 20, 2001	AB	RX	Yes	No

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	5,292,740
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001	5,292,740

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/000401Treatment 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:

Canada

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
Germany	602006011150
Israel	102138	Sulphonamides their preparation and intermediates therefor and pharmaceutical compositions containing the sulphonamides
South Korea	20100093105	DISPERSIBLE TABLET
Japan	H0730042
Mexico	2007014454	TABLETA DE BOSENTAN DISPERSABLE. (DISPERSIBLE BOSERTAN TABLET.)

Supplementary Protection Certificates for TRACLEER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0526708	02C0042	France		PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
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

TRACLEER (bosentan) — Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is TRACLEER and where does it compete?

TRACLEER is bosentan, an oral dual endothelin receptor antagonist (ETA/ETB) used in pulmonary arterial hypertension (PAH). The product has long-standing presence in PAH after launch in the early 2000s and competes within a category that has shifted over time toward newer oral agents and, in some markets, earlier use of combination therapy.

Core competitive set (mechanism and use-case overlap):

• Other PAH endothelin pathway agents: endothelin receptor antagonists (e.g., ambrisentan, macitentan)
• PAH prostacyclin pathway agents (including oral and inhaled agents)
• PAH pathway combination regimens (endothelin + PDE5 inhibitor and/or prostacyclin components)

Market where TRACLEER has historically been concentrated:

• PAH specialty care with pricing and access heavily influenced by reimbursement coverage and guideline positioning, not just competitive efficacy.

How have PAH treatment dynamics reshaped demand for TRACLEER?

PAH prescribing has been progressively shaped by three structural forces:

1. Shift toward long-acting and higher convenience regimens

   • Oral endothelin receptor antagonists with once-daily dosing and/or improved tolerability profile have gained share as treatment algorithms moved toward regimen simplicity and sustained exposure.
   • In practice, prescribers often prefer newer endothelin agents when efficacy and safety are broadly comparable, especially under reimbursement constraints.

2. Increasing reliance on combination therapy and earlier escalation

   • PAH management has moved toward combination approaches and tighter guideline-driven escalation.
   • TRACLEER remains used, but category adoption patterns tend to favor agents with favorable dosing and established positioning in modern algorithms.

3. Safety monitoring constraints

   • TRACLEER requires liver enzyme monitoring and has known tolerability considerations consistent with class.
   • These requirements impact real-world adoption dynamics, especially for payer scrutiny and clinic workflow.

The consequence for TRACLEER’s commercial trajectory is that its addressable demand has been pressured by intraclass substitution and evolving guideline algorithms that increasingly distribute new starts and intensification among newer PAH agents.

What do market events indicate about TRACLEER’s financial trajectory?

Bosentan’s long commercial history means its financial path is driven more by share shifts and gross-to-net compression than by growth from expansion of indications. The trajectory is typically characterized by:

• Steady base revenue in established PAH centers
• Ongoing share loss to newer endothelin agents and combination regimens
• Revenue protection through lifecycle management and contracting, not through net-new category creation

A key public reference point is how the brand has been treated in large pharmaceutical commercial disclosures over time. For example, Actelion’s portfolio reporting and subsequent business integration provide evidence that TRACLEER is treated as a mature product within PAH and that financial performance is monitored as part of a broader PAH franchise under ownership transitions. (See cited sources on Actelion/portfolio context and PAH revenues.) [1][2]

Evidence anchor: Actelion’s PAH franchise reporting context

• Actelion’s financial reporting historically grouped PAH assets including bosentan (TRACLEER) as part of its core commercial portfolio. Following corporate restructuring and acquisitions, subsequent reporting continued to reflect that TRACLEER is a mature asset within a competitive PAH landscape rather than a growth driver. [1][2]

How does gross-to-net pressure usually affect TRACLEER in mature PAH?

For long-cycle specialty brands like TRACLEER, financial trajectory typically follows a mature-branded model:

• List price growth is constrained by payer contracting
• Discounting and rebates increase as competition intensifies
• Formulary placement remains stable only with continued contracting and evidence generation

Because TRACLEER faces active intraclass competition (and later-stage competition across PAH pathways), its economics are more sensitive to:

• payer formulary decisions
• utilization management
• contract renegotiations tied to class competition

This drives a characteristic pattern:

• Revenue can remain positive for years, but growth depends on contracting rather than on new volume expansion.

What is the demand funnel like for bosentan in PAH today?

TRACLEER’s demand funnel is shaped by specialty prescribing behavior:

• New starts: patients likely to receive newer agents if payer coverage and guideline interpretations favor them.
• Switching: clinicians may switch to alternatives due to tolerability, dosing convenience, and perceived ease of use.
• Add-on therapy: TRACLEER can remain in combination regimens where already established, but it competes for therapy slots as prescribers optimize for modern regimens.

Net effect: TRACLEER’s volume growth tends to be modest and offset by substitution rather than enabled by category expansion.

What competitive dynamics matter most for TRACLEER?

Intraclass substitution within endothelin receptor antagonists

Bosentan is one of the earliest agents in its class. As newer endothelin agents have established broader uptake, TRACLEER faces:

• competition for new patient initiations
• contract-driven incentives favoring alternative agents
• prescriber preference shifts influenced by dosing convenience and safety profile perceptions

Class expansion that still does not fully protect mature incumbents

Even if PAH prevalence management and diagnosis improve, mature agents often do not capture proportional share of incremental demand because:

• formularies may steer new therapy toward newer agents
• combination therapy selection increasingly favors different endothelin backbones depending on region and contracting

Ownership and portfolio transitions

TRACLEER’s financial trajectory is also influenced by corporate transitions affecting how brands are marketed, supported, and contract-managed:

• Actelion’s acquisition and subsequent restructuring changed reporting structures and commercial focus across PAH assets. [1][2]

What does the “product maturity” profile imply for financial performance?

For TRACLEER, product maturity implies:

• no new indications at a magnitude that would reset the revenue curve
• revenue outcomes tied to competitive share and contracting
• performance that can stabilize but not typically re-accelerate without major clinical or policy catalysts

In mature PAH markets, revenue trajectories for older oral agents often look like:

• baseline demand retention in ongoing patients
• declining or flat new starts against newer alternatives
• net revenue growth, if any, driven by price and contract rather than volume

How long-term patent and lifecycle risk affects the financial trajectory

Bosentan-based brands are exposed to lifecycle risk that typically emerges through:

• patent expirations and generic substitution pressure in the long run (market timing depends on jurisdiction and rights)
• line-extension strategies that may or may not fully prevent competition
• ongoing payer and prescriber migration to alternatives even before generic entry in some geographies

Because TRACLEER is a legacy brand, the long-run financial profile is vulnerable to generic or alternative competition timelines even when short-term demand remains stable.

Regional access and reimbursement dynamics

PAH is a high-reimbursement specialty area in many markets, but access is governed by:

• requirement for diagnosis confirmation
• restricted prescribing rights
• step therapy rules and payer-specific preferred agents

That means TRACLEER’s market share depends not only on clinical uptake but on:

• formulary “preferred” list status for endothelin agents
• reimbursement stability for liver monitoring requirements and patient eligibility

Financial trajectory summary table

The table below consolidates the commercial logic typically reflected in mature PAH franchise performance and aligns with publicly reported franchise ownership context.

Dimension	TRACLEER position	Financial implication
Category growth	PAH remains a stable specialty market with diagnosis-driven demand	Limited share capture in new initiations
Intraclass competition	Competes with newer endothelin receptor antagonists	Ongoing share erosion risk
Mechanism competition	Competes across PAH pathways in combination regimens	Therapy slot competition
Real-world adoption	Requires liver monitoring and has established tolerability profile	Slows net new patient uptake
Commercial maturity	Legacy PAH franchise asset	Revenue stabilizes, growth depends on contracting
Corporate/portfolio context	Reported historically within Actelion PAH franchise	Marketing and contracting may shift post-transactions

Market outlook: what signals to track for TRACLEER

For business monitoring, the high-signal indicators are:

• PAH preferred formulary status for endothelin receptor antagonists by payer tier
• share of new PAH starts by agent class (endothelin backbone selection)
• switching patterns in claims data from bosentan to other endothelin agents
• contract renegotiation cadence tied to gross-to-net changes
• availability of generics/authorized competition by jurisdiction over time

Key Takeaways

• TRACLEER is a mature oral endothelin receptor antagonist in PAH with demand largely shaped by intraclass substitution and combination-therapy prescribing rather than by major new category expansion.
• Its financial trajectory is characterized by revenue stability in existing patient populations and share pressure from newer endothelin agents and broader PAH regimen selection.
• The economics are sensitive to payer contracting (gross-to-net) and to the clinical and operational burden of monitoring.
• Long-run risk is tied to the typical lifecycle path for legacy PAH assets, including potential generic competition exposure and continued formulary preference migration.

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FAQs

1) What patient segment most supports TRACLEER revenues?

Patients already established on bosentan in PAH who remain on therapy through specialty follow-up cycles, with ongoing support from stable reimbursement and continued physician familiarity.

2) What is the main commercial threat to TRACLEER in PAH?

Intraclass replacement within endothelin receptor antagonists and displacement within PAH combination regimens as payers and clinicians favor newer options.

3) Does PAH category growth automatically lift TRACLEER?

No. Even when PAH demand grows, TRACLEER’s share depends on formulary steering, preferred-agent status, and therapy backbone selection for new starts.

4) Why does monitoring burden matter commercially?

Liver monitoring requirements influence clinic workflow and can affect payer and prescriber comfort, indirectly impacting new uptake and payer authorization patterns.

5) How does ownership structure affect how TRACLEER is managed financially?

Portfolio changes following corporate transactions shape reporting focus, marketing investment, and contract strategy across PAH brands, which influences revenue outcomes for mature products.

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References

1. Actelion Pharmaceuticals Ltd. (2017). Annual report 2016 (includes PAH franchise context and consolidated portfolio reporting).
2. Johnson & Johnson. (2018). Acquisition of Actelion and subsequent portfolio disclosures (context for PAH asset ownership and reporting after transaction).
3. European Medicines Agency. (Bosentan product information / EPAR entries for TRACLEER).
4. FDA. (TRACLEER label, bosentan prescribing information and safety monitoring requirements).
5. Clinical guidelines literature on PAH treatment sequencing and endothelin receptor antagonist positioning (guideline updates referenced in market practice).