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PIMAVANSERIN

ANDA

PIMAVANSERIN TARTRATE | A214493 | ZYDUS WORLDWIDE DMCC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
ACADIA Pharmaceuticals Inc. v. Zydus Pharmaceuticals (USA) Inc. et al 1:2022cv01386 4 patentsANDA 214493Pimavanserin tartrate	D. Del.	2022-10-21	Terminated 2023-04-05	—
ACADIA Pharmaceuticals Inc. v. Zydus Pharmaceuticals (USA) Inc. et al 1:2020cv01021 5 patentsANDA 214493, 214502pimavanserin	D. Del.	2020-07-30	Terminated 2023-04-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain6 active DMFs1 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

MSN LIFE SCIENCES PRIVATE LTDPIMAVANSERIN TARTRATE

DMF 332922018

ZAKLADY FARMACEUTYCZNE POLPHARMA SAPIMAVANSERIN TARTRATE

DMF 333852018

DASAMI LAB PRIVATE LTDPIMAVANSERIN TARTRATE

DMF 343542020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPIMAVANSERIN TARTRATE

DMF 344152019

ZYDUS LIFESCIENCES LTDPIMAVANSERIN TARTRATE

DMF 350292020

JIANGSU TASLY DIYI PHARMACEUTICAL CO LTDPIMAVANSERIN TARTRATE

DMF 374302022

LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTDInactivePIMAVANSERIN TARTRATE (NON-STERILE, BULK FORM)

DMF 342892019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 14, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 34MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 16, 2024

No patent or exclusivity listings for this strength.