Last Updated: June 24, 2026

Details for New Drug Application (NDA): 209279

✉ Email this page to a colleague

NDA 209279 describes TRACLEER, which is a drug marketed by Actelion and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRACLEER profile page.

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.

Summary for 209279

Tradename:	TRACLEER
Applicant:	Actelion
Ingredient:	bosentan
Patents:	2

Pharmacology for NDA: 209279

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

Suppliers and Packaging for NDA: 209279

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279	NDA	Actelion Pharmaceuticals US, Inc.	66215-232	66215-232-56	4 BLISTER PACK in 1 CARTON (66215-232-56) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66215-232-14)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	32MG
Approval Date:	Sep 5, 2017	TE:	AB	RLD:	Yes
Patent:	7,959,945	Patent Expiration:	Dec 28, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,309,126	Patent Expiration:	May 15, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 209279

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017	8,309,126	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.