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 nine 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 210793
| Tradename: | NUPLAZID |
| Applicant: | Acadia Pharms Inc |
| Ingredient: | pimavanserin tartrate |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 34MG BASE | ||||
| Approval Date: | Jun 28, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
| Regulatory Exclusivity Expiration: | Oct 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | 10,449,185*PED | Patent Expiration: | Feb 27, 2039 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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 | 7,923,564 | ⤷ Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | 10,028,944 | ⤷ Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | 8,110,574 | ⤷ Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | 9,566,271 | ⤷ Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | 6,815,458 | ⤷ Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | 8,921,393 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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