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Generated: November 18, 2018

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Details for New Drug Application (NDA): 204886

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NDA 204886 describes ZONTIVITY, which is a drug marketed by Aralez Pharms and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ZONTIVITY profile page.

The generic ingredient in ZONTIVITY is vorapaxar sulfate. One supplier is listed for this compound. Additional details are available on the vorapaxar sulfate profile page.
Summary for 204886
Tradename:ZONTIVITY
Applicant:Aralez Pharms
Ingredient:vorapaxar sulfate
Patents:3
Generic Entry Opportunity Date for 204886
Generic Entry Date for 204886*:
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: 204886
Suppliers and Packaging for NDA: 204886
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONTIVITY vorapaxar sulfate TABLET;ORAL 204886 NDA Aralez Pharmaceuticals Us Inc. 70347-208 70347-208-05 5 TABLET, FILM COATED in 1 BLISTER PACK (70347-208-05)
ZONTIVITY vorapaxar sulfate TABLET;ORAL 204886 NDA Aralez Pharmaceuticals Us Inc. 70347-208 70347-208-30 30 TABLET, FILM COATED in 1 BOTTLE (70347-208-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.08MG BASE
Approval Date:May 8, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:May 8, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Jun 13, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Apr 6, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS

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