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: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210793

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NDA 210793 describes NUPLAZID, which is a drug marketed by Acadia Pharms Inc and is included in two NDAs. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the NUPLAZID profile page.

The generic ingredient in NUPLAZID is pimavanserin tartrate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pimavanserin tartrate profile page.
Summary for 210793
Tradename:NUPLAZID
Applicant:Acadia Pharms Inc
Ingredient:pimavanserin tartrate
Patents:15
Generic Entry Opportunity Date for 210793
Generic Entry Date for 210793*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 210793
Suppliers and Packaging for NDA: 210793
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793 NDA ACADIA Pharmaceuticals Inc 63090-340 63090-340-30 30 CAPSULE in 1 BOTTLE, PLASTIC (63090-340-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 34MG BASE
Approval Date:Jun 28, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 29, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jan 15, 2024Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 6, 2021Product Flag?YSubstance Flag?YDelist Request?

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