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GEODON

NDA

ZIPRASIDONE MESYLATE | N020919 | VIATRIS SPECIALTY 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

3 petitions (3 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Amended Suitability Petition from RegCon Solutions, LLC FDA-2024-P-0425 RegCon Solutions, LLC submitted this suitability petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Ziprasidone Mesylate Injection, 20 mg/mL in a prefilled syringe suitable for submission as an ANDA, based on the reference listed drug GEODON for	Suitability	2024-02-15	Open	RegCon Solutions
Suitability Petition from RegCon Solutions, LLC FDA-2024-P-0425 RegCon Solutions, LLC submitted this suitability petition under Section 505(j) requesting FDA approval to file an abbreviated new drug application (ANDA) for Ziprasidone Mesylate Injection 20 mg/mL in a prefilled syringe, proposing a change in dosage form from the lyophilized reference listed drug G	Suitability	2024-01-23	Open	RegCon Solutions
Citizen Petition From Gland Pharma, Inc. FDA-2015-P-0547 Gland Pharma Limited submitted this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA declare Ziprasidone Mesylate for Injection in strengths of 10 mg base per 0.5 mL vial and 40 mg base per 2 mL vial suitable for submissi	Other	2015-02-20	Open	Gland Pharma

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

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Maternal And Infant Antipsychotic Study NCT06049953	—	Recruiting	Icahn School of Medicine at Mount Sinai	74	2023-09-29 → 2028-01-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain3 active DMFs

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

MSN LIFE SCIENCES PRIVATE LTDZIPRASIDONE MESYLATE TRIHYDRATE

DMF 347152020

SUN PHARMACEUTICAL INDUSTRIES LTDZIPRASIDONE MESYLATE TRIHYDRATE

DMF 377592023

APITORIA PHARMA PRIVATE LTDZIPRASIDONE MESYLATE TRIHYDRATE

DMF 387452023

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

Approval Letters

25 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 20MG BASE/VIAL

RLDAP

0 patents0 exclusivities▴

POWDER;INTRAMUSCULAR | Approved: Jun 21, 2002

No patent or exclusivity listings for this strength.