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Details for New Drug Application (NDA): 207318
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NDA 207318 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 seventeen 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.
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 207318
| Tradename: | NUPLAZID |
| Applicant: | Acadia Pharms Inc |
| Ingredient: | pimavanserin tartrate |
| Patents: | 16 |
Generic Entry Opportunity Date for 207318
Generic Entry Date for 207318*:
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: 207318
Suppliers and Packaging for NDA: 207318
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318 | NDA | ACADIA Pharmaceuticals Inc | 63090-100 | 63090-100-30 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (63090-100-30) |
| NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318 | NDA | ACADIA Pharmaceuticals Inc | 63090-170 | 63090-170-60 | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (63090-170-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 17MG BASE | ||||
| Approval Date: | Apr 29, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 29, 2021 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jan 15, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS | ||||||||
| Patent: | Start Trial | Patent Expiration: | Mar 6, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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