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Last Updated: May 19, 2022

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 fourteen 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:12
DrugPatentWatch® Estimated 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
Patent:See Plans and PricingPatent Expiration:Jan 15, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS
Patent:See Plans and PricingPatent Expiration:Aug 27, 2038Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Aug 27, 2038Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 210793

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018 See Plans and Pricing See Plans and Pricing
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018 See Plans and Pricing See Plans and Pricing
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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