Viewing data from:

GEODON

NDA

ZIPRASIDONE HYDROCHLORIDE | N020825 | VIATRIS SPECIALTY LLC

4 strengths0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

112 trials from ClinicalTrials.gov — 1 recruiting, 88 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia NCT03781115	Phase 1	Recruiting	University of Arizona	24	2017-11-20 → 2026-02-10
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects NCT00312494	Phase 3	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	680	2006-04 → 2008-12
The MIND Study: Modifying the INcidence of Delirium NCT00096863	Phase 2	Completed	Vanderbilt University	102	2004-12 → 2007-07
Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder NCT00395031	Phase 2/3	Completed	Manhattan Psychiatric Center	57	2003-09 → 2010-01
Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone NCT00910988	N/A	Completed	Washington University School of Medicine	46	2009-02 → 2012-06
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial NCT00224315	Phase 4	Completed	Central Institute of Mental Health, Mannheim	24	2003-11 → 2006-09
Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia NCT00254202	Phase 3	Completed	Vanda Pharmaceuticals	593	2005-11-18 → 2007-03-21
Adjunctive Ziprasidone in the Treatment of Bipolar I Depression NCT00483548	Phase 3	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	298	2007-10 → 2008-12
Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State NCT00490542	Phase 2	Completed	Tufts Medical Center	73	2006-12 → 2009-08
A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients NCT00645372	Phase 3	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	242	2004-07 → 2005-05

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$31.11

per ea

Lowest NADAC/Unit

$31.11

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00049035860GEODON 80 MG CAPSULE	$31.11	EA	Brand	$0.3596	2026-01-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$821.40

Highest Price

$1144.11

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00049-0356-60GEODON 60MG CAP	$1144.11	FSS	Mylan Specialty L.P.	01/14/2027
00049-0356-60GEODON 60MG CAP	$1144.11	Big4	Mylan Specialty L.P.	01/14/2027
00049-0352-60GEODON 20MG CAP	$942.77	FSS	Mylan Specialty L.P.	01/14/2027
00049-0352-60GEODON 20MG CAP	$942.77	Big4	Mylan Specialty L.P.	01/14/2027
00049-0358-60GEODON 80MG CAP	$1144.11	FSS	Mylan Specialty L.P.	01/14/2027
00049-0358-60GEODON 80MG CAP	$1144.11	Big4	Mylan Specialty L.P.	01/14/2027
00049-0354-60GEODON 40MG CAP	$821.40	FSS	Mylan Specialty L.P.	01/14/2027
00049-0354-60GEODON 40MG CAP	$821.40	Big4	Mylan Specialty L.P.	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Geodon — Ziprasidone HCl (2024)

Total Spending

$5.4M

Total Claims

2,605

Beneficiaries

316

Avg Cost/Unit

$27.89

Spending Trend

$9.8M(2019)→$9.3M(2020)→$7.8M(2021)→$6.6M(2022)→$6.3M(2023)→$5.4M(2024)

YoY Change:-0.1%

5yr CAGR:+4.8%

Geodon — Ziprasidone Mesylate (2024)

Total Spending

$25K

Total Claims

129

Beneficiaries

Avg Cost/Unit

$66.70

Spending Trend

$704K(2019)→$508K(2020)→$129K(2021)→$53K(2022)→$21K(2023)→$25K(2024)

YoY Change:+4.9%

5yr CAGR:+7.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain14 active DMFs7 inactive

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

DR REDDYS LABORATORIES LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 179222004

APOTEX INCZIPRASIDONE HYDROCHLORIDE

DMF 180502005

LUPIN LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 180552005

WOCKHARDT LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

DMF 195032006

ZYDUS LIFESCIENCES LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

DMF 207692007

APITORIA PHARMA PRIVATE LTDZIPRASIDONE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 210122007

DR REDDYS LABORATORIES LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

DMF 211472007

MEGAFINE PHARMA P LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (NON STERILE DRUG SUBSTANCE)

DMF 237392010

JUBILANT BIOSYS LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 249552011

MACLEODS PHARMACEUTICALS LTDZIPRASIDONE HYDROCHLORIDE

DMF 250482011

AMINO CHEMICALS LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

DMF 272592013

RAKS PHARMA PVT LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE, USP

DMF 311832016

APOTEX INCZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

DMF 331732018

CHROMO LABORATORIES INDIA PRIVATE LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 339912019

RANBAXY LABORATORIES LTDInactiveZIPRASIDONE HYDROCHLORIDE

DMF 180422005

CADILA HEALTHCARE LTDInactiveZIPRASIDONE HYDROCHLORIDE ANHYDROUS

DMF 189522005

TEVA PHARMACEUTICALS INDUSTRIES LTDInactiveZIPRASIDONE HYDROCHLORIDE

DMF 190052005

AMINO CHEMICALS LTDInactiveZIPRASIDONE HYDROCHLORIDE ANHYDROUS

DMF 201052006

WATSON PHARMA PRIVATE LTDInactiveZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

DMF 243472010

QILU TIANHE PHARMACEUTICAL CO LTDInactiveZIPRASIDONE HYDROCHLORIDE (NON - STERILE API)

DMF 248372011

HETERO DRUGS LTDInactiveZIPRASIDONE HYDROCHLORIDE, USP

DMF 260452012

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

Approval Letters

28 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -65	View Letter (PDF)
Jan 31, 2022	SUPPL -63	View Letter (PDF)
May 19, 2021	SUPPL -62	View Letter (PDF)
Nov 2, 2020	SUPPL -61	View Letter (PDF)
Jan 24, 2020	SUPPL -58	View Letter (PDF)
Nov 16, 2018	SUPPL -59	View Letter (PDF)
Mar 2, 2017	SUPPL -56	View Letter (PDF)
Aug 24, 2015	SUPPL -54	View Letter (PDF)
Dec 11, 2014	SUPPL -53	View Letter (PDF)
Dec 19, 2013	SUPPL -49	View Letter (PDF)
Aug 16, 2013	SUPPL -47	View Letter (PDF)
Jul 5, 2013	SUPPL -41	View Letter (PDF)
Mar 5, 2013	SUPPL -46	View Letter (PDF)
Dec 7, 2010	SUPPL -38	View Letter (PDF)
Nov 24, 2009	SUPPL -34	View Letter (PDF)
Aug 4, 2009	SUPPL -35	View Letter (PDF)
Aug 19, 2008	SUPPL -30	View Letter (PDF)
May 21, 2008	SUPPL -27	View Letter (PDF)
Oct 4, 2007	SUPPL -26	View Letter (PDF)
May 29, 2007	SUPPL -24	View Letter (PDF)
Mar 7, 2007	SUPPL -21	View Letter (PDF)
Aug 19, 2005	SUPPL -17	View Letter (PDF)
Aug 19, 2005	SUPPL -15	View Letter (PDF)
Oct 1, 2004	SUPPL -9	View Letter (PDF)
Aug 25, 2004	SUPPL -12	View Letter (PDF)
Dec 24, 2003	SUPPL -8	View Letter (PDF)
Feb 15, 2002	SUPPL -6	View Letter (PDF)
Feb 5, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 20MG BASE

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 5, 2001

No patent or exclusivity listings for this strength.

#002 — EQ 40MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 5, 2001

#003 — EQ 60MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 5, 2001

#004 — EQ 80MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 5, 2001