Viewing data from:

ZYPREXA ZYDIS

NDA

OLANZAPINE | N021086 | CHEPLAPHARM REGISTRATION GMBH

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

312 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 253 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Intranasal Insulin and Olanzapine Study in Healthy Volunteers NCT03741478	Phase 1	Active	Centre for Addiction and Mental Health	64	2019-10-22 → 2026-07-30
Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma NCT04216329	Phase 1	Active	National Cancer Institute (NCI)	11	2020-07-07 → 2028-07-30
RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy NCT03118986	Phase 2	Recruiting	The Hospital for Sick Children	200	2017-08-10 → 2026-04
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
The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals NCT02536846	Phase 4	Completed	Dost Ongur	35	2017-11-17 → 2019-11-08
Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis NCT04232423	Phase 3	Completed	Department of Medical Services Ministry of Public Health of Thailand	90	2020-03-01 → 2021-09-30
D-serine Monotherapy for Schizophrenia NCT00816894	Phase 2	Completed	Herzog Hospital	18	2009-01 → 2013-02
Olanzapine in the Treatment of Hair Pulling (Trichotillomania)NCT00182507	Phase 4	Completed	Hamilton Health Sciences Corporation	34	2000-06 → 2006-03
Early Predictors of Poor Treatment Response in Patients With Schizophrenia Treated With Atypical Antipsychotics NCT03730857	Phase 1	Completed	Calo Psychiatric Center	111	2008-01 → 2008-12
Individualised Versus Standard Care for Breast Cancer Patients at High-risk for Chemotherapy-induced Nausea and Vomiting The ILIAD Study NCT02861859	Phase 3	Completed	Ottawa Hospital Research Institute	221	2016-12 → 2019-12-23

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$375.45

Highest Price

$1033.22

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00002-4454-85ZYPREXA ZYDIS 10MG TAB	$698.99	FSS	H2-Pharma, LLC	10/01/2026
00002-4454-85ZYPREXA ZYDIS 10MG TAB	$554.89	Big4	H2-Pharma, LLC	10/01/2026
00002-4455-85ZYPREXA ZYDIS 15MG TAB	$1033.22	FSS	H2-Pharma, LLC	10/01/2026
00002-4455-85ZYPREXA ZYDIS 15MG TAB	$821.35	Big4	H2-Pharma, LLC	10/01/2026
00002-4453-85ZYPREXA ZYDIS 5MG TAB	$474.23	FSS	H2-Pharma, LLC	10/01/2026
00002-4453-85ZYPREXA ZYDIS 5MG TAB	$375.45	Big4	H2-Pharma, LLC	10/01/2026

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

Medicare Part D Spending

CMS annual spending data for Zyprexa Zydis (2024)

Total Spending

$3.0M

Total Claims

1,766

Beneficiaries

255

Avg Cost/Unit

$33.69

Spending Trend

$4.3M(2019)→$4.2M(2020)→$3.8M(2021)→$3.6M(2022)→$3.5M(2023)→$3.0M(2024)

YoY Change:+1.3%

5yr CAGR:+1.9%

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

API Supply Chain28 active DMFs12 inactive

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

DR REDDYS LABORATORIES LTDOLANZAPINE (FORM 1) USP

DMF 152992001

SOLARA ACTIVE PHARMA SCIENCES LTDOLANZAPINE USP

DMF 182602005

NEULAND LABORATORIES LTDOLANZAPINE FORM-1 USP

DMF 192822006

TAPI NL BVOLANZAPINE USP

DMF 202182007

HETERO DRUGS LTDOLANZAPINE (FORM-1)

DMF 205912007

JUBILANT PHARMOVA LTDOLANZAPINE USP (FORM-I)

DMF 209902007

SUN PHARMACEUTICAL INDUSTRIES LTDOLANZAPINE USP

DMF 215062008

APOTEX INCOLANZAPINE USP

DMF 219802008

CADILA PHARMACEUTICALS LTDOLANZAPINE FORM-I USP

DMF 223012008

TORRENT PHARMACEUTICALS LTDOLANZAPINE

DMF 225552009

APITORIA PHARMA PRIVATE LTDOLANZAPINE USP (NON-STERILE DRUG SUBSTANCE)

DMF 235252010

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDOLANZAPINE

DMF 235972010

ORBION PHARMACEUTICALS PRIVATE LTDOLANZAPINE

DMF 240202010

MACLEODS PHARMACEUTICALS LTDOLANZAPINE USP

DMF 243332010

QILU PHARMACEUTICAL CO LTDOLANZAPINE

DMF 251752011

ZYDUS LIFESCIENCES LTDOLANZAPINE USP

DMF 260722012

INKE SAOLANZAPINE

DMF 266942013

HEC PHARM CO LTDOLANZAPINE NON-STERILE BULK DRUG SUBSTANCE

DMF 267632012

APOTEX INCOLANZAPINE USP

DMF 294442015

APITORIA PHARMA PRIVATE LTDOLANZAPINE USP (CRYSTALLINE POLYMORPH FORM-II)

DMF 297892015

JUBILANT BIOSYS LTDOLANZAPINE USP

DMF 303522016

CHROMO LABORATORIES INDIA PRIVATE LTDOLANZAPINE USP

DMF 332212022

IPCA LABORATORIES LTDOLANZAPINE USP

DMF 371012022

APOTEX INCOLANZAPINE FORM II USP

DMF 371222022

LEE PHARMA LTDOLANZAPINE (FORM-I)

DMF 391502023

TAPI NL BVOLANZAPINE FORM II

DMF 400352025

SAI SREYAS PHARMACEUTICAL PRIVATE LTDOLANZAPINE INTERMEDIATE- 4-AMINO-2-METHYL-10H-THIENE[2,3-B][1,5]BENZODIAZEPINE HYDROCHLORIDE (OLZ-3) IH (CAS NUMBER- 138564-60-0)

DMF 435542026

ALKEM LABORATORIES LIMITEDOLANZAPINE

DMF 438812026

CIPLA LTDInactiveOLANZAPINE

DMF 150522000

VENKAT PHARMA LTDInactiveOLANZAPINE

DMF 181082005

MYLAN LABORATORIES LTDInactiveOLANZAPINE

DMF 188672005

CADILA HEALTHCARE LTDInactiveOLANZAPINE

DMF 191682006

LEK PHARMACEUTICALS DDInactiveOLANZAPINE

DMF 203542007

RANBAXY LABORATORIES LTDInactiveOLANZAPINE DRUG SUBSTANCE

DMF 219472008

ALKEM LABORATORIES LTDInactiveOLANZAPINE USP

DMF 240162010

JIANGSU HANSOH PHARMACEUTICAL CO LTDInactiveOLANZAPINE NON-STERILE BULK DRUG SUBSTANCE

DMF 244802010

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveOLANZAPINE USP

DMF 272192013

KYONGBO PHARMACEUTICAL CO LTDInactiveOLANZAPINE

DMF 289762015

CIPLA LTDInactiveOLANZAPINE USP

DMF 290632015

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDInactiveOLANZAPINE USP, NON-STERILE

DMF 300412016

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

Approval Letters

26 letters from Drugs@FDA

Date	Submission	Document
Feb 3, 2026	SUPPL -53	View Letter (PDF)
Feb 7, 2025	SUPPL -50	View Letter (PDF)
Apr 24, 2020	SUPPL -48	View Letter (PDF)
Apr 22, 2020	SUPPL -49	View Letter (PDF)
Oct 23, 2019	SUPPL -47	View Letter (PDF)
Mar 29, 2018	SUPPL -46	View Letter (PDF)
Mar 2, 2017	SUPPL -45	View Letter (PDF)
Mar 2, 2017	SUPPL -44	View Letter (PDF)
Oct 14, 2016	SUPPL -43	View Letter (PDF)
Dec 23, 2014	SUPPL -40	View Letter (PDF)
Jul 30, 2013	SUPPL -41	View Letter (PDF)
Jun 27, 2011	SUPPL -38	View Letter (PDF)
Jun 27, 2011	SUPPL -39	View Letter (PDF)
Dec 6, 2010	SUPPL -36	View Letter (PDF)
Jun 3, 2010	SUPPL -34	View Letter (PDF)
Jun 3, 2010	SUPPL -32	View Letter (PDF)
Feb 1, 2010	SUPPL -31	View Letter (PDF)
Nov 19, 2009	SUPPL -30	View Letter (PDF)
Aug 19, 2008	SUPPL -28	View Letter (PDF)
Jul 10, 2007	SUPPL -22	View Letter (PDF)
Jul 10, 2007	SUPPL -23	View Letter (PDF)
Dec 28, 2006	SUPPL -20	View Letter (PDF)
Sep 18, 2006	SUPPL -11	View Letter (PDF)
Mar 1, 2006	SUPPL -16	View Letter (PDF)
Sep 15, 2005	SUPPL -15	View Letter (PDF)
Apr 6, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Apr 6, 2000

No patent or exclusivity listings for this strength.

#002 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Apr 6, 2000

#003 — 15MG

RLDAB

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Apr 6, 2000

#004 — 20MG

RLDAB

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Apr 6, 2000