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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. There are eighteen 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. 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. 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.
Paragraph IV (Patent) Challenges for 207318
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NUPLAZID | TABLET;ORAL | pimavanserin tartrate | 207318 | 2020-04-29 |
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: | |||||||||
| Patent: | Start Trial | Patent Expiration: | Jan 15, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patent: | Start Trial | Patent Expiration: | Mar 6, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 207318
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318-001 | Apr 29, 2016 | Start Trial | Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318-002 | Jun 28, 2018 | Start Trial | Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318-002 | Jun 28, 2018 | Start Trial | Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318-001 | Apr 29, 2016 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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