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DAPIPRAZOLE HYDROCHLORIDE

NDA

DAPIPRAZOLE HYDROCHLORIDE | N019849 | FERA PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
CUSTOpharm, Inc. - Citizen Petition FDA-2012-P-1000 · 5 docket documents CUSTOpharm, Inc. filed this citizen petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA Commissioner determine that Dapiprazole Hydrochloride Ophthalmic Solution 0.5%, the reference listed drug approved under NDA 19-849, was not withdrawn for safety	505(q)	2012-09-28	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ANGELINI ACRAF SPADAPIPRAZOLE HYDROCHLORIDE

DMF 43341981

NEULAND LABORATORIES LTDDAPIPRAZOLE HYDROCHLORIDE

DMF 263472012

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

Products (1)

#001 — 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Dec 31, 1990

No patent or exclusivity listings for this strength.