DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 210793
» See Plans and Pricing
NDA 210793 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 210793
| Tradename: | NUPLAZID |
| Applicant: | Acadia Pharms Inc |
| Ingredient: | pimavanserin tartrate |
| Patents: | 17 |
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.
Paragraph IV (Patent) Challenges for 210793
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NUPLAZID | CAPSULE;ORAL | pimavanserin tartrate | 210793 | 2020-04-29 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 34MG BASE | ||||
| Approval Date: | Jun 28, 2018 | 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: | Aug 27, 2038 | Product Flag? | Y | Substance 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 | Start Trial | Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
