Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209279

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NDA 209279 describes TRACLEER, which is a drug marketed by Actelion Pharms and Actelion Pharms Ltd and is included in two NDAs. It is available from two suppliers. 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. Eleven suppliers are listed for this compound. Additional details are available on the bosentan profile page.
Summary for 209279
Tradename:TRACLEER
Applicant:Actelion Pharms
Ingredient:bosentan
Patents:2
Formulation / Manufacturing:see details
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. 66215-103 66215-103-56 4 BLISTER PACK in 1 CARTON (66215-103-56) > 14 TABLET, SOLUBLE in 1 BLISTER PACK (66215-103-14)
Paragraph IV (Patent) Challenges for 209279
Tradename Dosage Ingredient NDA Submissiondate
TRACLEER TABLET, FOR SUSPENSION;ORAL bosentan 209279 2019-02-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength32MG
Approval Date:Sep 5, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 5, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Sep 5, 2024
Regulatory Exclusivity Use:TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) IN PEDIATRIC PATIENTS AGED 3 YRS AND OLDER WITH IDIOPATHIC OR CONGENITAL PAH TO IMPROVE PULMONARY VASCULAR RESISTANCE (PVR), WHICH IS EXPECTED TO RESULT IN AN IMPROVEMENT IN EXERCISE ABILITY
Patent:  Start TrialPatent Expiration:Dec 28, 2027Product Flag?YSubstance Flag?Delist Request?

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