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 5, 2019

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. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DOPTELET profile page.

The generic ingredient in DOPTELET is avatrombopag maleate. One supplier is listed for this compound. 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.

Suppliers and Packaging for NDA: 210238
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOPTELET avatrombopag maleate TABLET;ORAL 210238 NDA AkaRx, Inc. 71369-020 71369-020-10 1 BLISTER PACK in 1 CARTON (71369-020-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-11)
DOPTELET avatrombopag maleate TABLET;ORAL 210238 NDA AkaRx, Inc. 71369-020 71369-020-15 1 BLISTER PACK in 1 CARTON (71369-020-15) > 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16)

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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