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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Citi
QuintilesIMS
Daiichi Sankyo
Moodys
Dow
Accenture
Express Scripts
Chubb

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021290

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NDA 021290 describes TRACLEER, which is a drug marketed by Actelion Pharms and Actelion Pharms Ltd and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the TRACLEER profile page.

The generic ingredient in TRACLEER is bosentan. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bosentan profile page.
Summary for 021290
Tradename:TRACLEER
Applicant:Actelion Pharms Ltd
Ingredient:bosentan
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021290
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRACLEER bosentan TABLET;ORAL 021290 NDA Actelion Pharmaceuticals US, Inc. 66215-101 N 66215-101-03
TRACLEER bosentan TABLET;ORAL 021290 NDA Actelion Pharmaceuticals US, Inc. 66215-101 N 66215-101-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength62.5MG
Approval Date:Nov 20, 2001TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 5, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Nov 20, 2001TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 5, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 021290

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Actelion Pharms Ltd TRACLEER bosentan TABLET;ORAL 021290-001 Nov 20, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Actelion Pharms Ltd TRACLEER bosentan TABLET;ORAL 021290-002 Nov 20, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Federal Trade Commission
Merck
McKinsey
Moodys
US Army
QuintilesIMS
Covington
Accenture

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