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Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210238


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NDA 210238 describes DOPTELET, which is a drug marketed by Akarx Inc and is included in one NDA. There are three patents protecting this drug. Additional details are available on the DOPTELET profile page.

The generic ingredient in DOPTELET is avatrombopag maleate. Additional details are available on the avatrombopag maleate profile page.
Summary for 210238
Tradename:DOPTELET
Applicant:Akarx Inc
Ingredient:avatrombopag maleate
Patents:3
Generic Entry Opportunity Date for 210238
Generic Entry Date for 210238*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:May 21, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:May 21, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jun 26, 2022
Regulatory Exclusivity Use:TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Regulatory Exclusivity Expiration:Jun 26, 2026
Regulatory Exclusivity Use:TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
AstraZeneca
Baxter
Mallinckrodt
Colorcon

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