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Generated: December 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207947

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NDA 207947 describes UPTRAVI, which is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the UPTRAVI profile page.

The generic ingredient in UPTRAVI is selexipag. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the selexipag profile page.
Summary for 207947
Tradename:UPTRAVI
Applicant:Actelion Pharms Ltd
Ingredient:selexipag
Patents:4
Generic Entry Opportunity Date for 207947
Generic Entry Date for 207947*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 207947
Suppliers and Packaging for NDA: 207947
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UPTRAVI selexipag TABLET;ORAL 207947 NDA Actelion Pharmaceuticals US, Inc. 66215-602 66215-602-06 1 BOTTLE in 1 CARTON (66215-602-06) > 60 TABLET, COATED in 1 BOTTLE
UPTRAVI selexipag TABLET;ORAL 207947 NDA Actelion Pharmaceuticals US, Inc. 66215-602 66215-602-14 1 BOTTLE in 1 CARTON (66215-602-14) > 140 TABLET, COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Dec 21, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 21, 2022
Regulatory Exclusivity Use:FOR USE OF UPTRAVI (SELEXIPAG) TABLETS, 200, 400, 600, 800, 1000, 1200, 1400, AND 1600 MCG FOR TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I) TO REDUCE THE RISKS OF DISEASE PROGRESSION AND HOSPITALIZATION FOR PAH
Regulatory Exclusivity Expiration:Dec 21, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Apr 4, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG

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