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Generated: December 16, 2017

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:1
Applicant:1
Ingredient:1
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 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

Summary 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

Summary 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 Orange Book Patents for NDA: 021290

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Actelion Pharms LtdTRACLEERbosentanTABLET;ORAL021290-001Nov 20, 2001► Subscribe► Subscribe
Actelion Pharms LtdTRACLEERbosentanTABLET;ORAL021290-002Nov 20, 2001► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Baxter
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Harvard Business School
Merck
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US Department of Justice

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