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Generated: November 17, 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 nineteen 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
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021290
Generic Entry Date for 021290*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 66215-101-03 10 BLISTER PACK in 1 CARTON (66215-101-03) > 3 TABLET, FILM COATED in 1 BLISTER PACK
TRACLEER bosentan TABLET;ORAL 021290 NDA Actelion Pharmaceuticals US, Inc. 66215-101 66215-101-06 1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

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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