Viewing data from:

ZYPREXA

NDA

OLANZAPINE | N020592 | CHEPLAPHARM REGISTRATION GMBH

6 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

181 trials from ClinicalTrials.gov — 6 recruiting, 3 active, 145 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of Antipsychotics on Brain Insulin Action in Females NCT06251635	N/A	Active	Centre for Addiction and Mental Health	15	2024-06-03 → 2026-12-31
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia NCT03781115	Phase 1	Active	University of Arizona	24	2017-11-20 → 2027-02-10
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial NCT06200181	Phase 3	Active	M.D. Anderson Cancer Center	69	2024-04-02 → 2026-11-01
GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer NCT07581405	Phase 2	Not Yet Recruiting	University of Illinois at Chicago	26	2026-09 → 2030-09
Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial NCT06995508	Phase 2	Recruiting	Roswell Park Cancer Institute	66	2025-12-24 → 2031-11-15
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer NCT05705492	Phase 2	Recruiting	OHSU Knight Cancer Institute	66	2024-07-17 → 2027-06-30
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder NCT05303064	Phase 3	Recruiting	Alkermes, Inc.	220	2022-06-30 → 2026-09
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile NCT07455955	Phase 2	Recruiting	Chinese University of Hong Kong	60	2026-03-31 → 2028-07-03
Exercise and Olanzapine-samidorphan NCT06740890	Phase 4	Recruiting	New York State Psychiatric Institute	30	2025-06-26 → 2027-04
An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)NCT07744113	—	AVAILABLE	Alkermes, Inc.	—	—

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$49.68

per ea

Lowest NADAC/Unit

$16.62

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61269063530ZYPREXA 20 MG TABLET	$49.68	EA	Brand	$0.1552	2026-10-21
61269063130ZYPREXA 5 MG TABLET	$16.62	EA	Brand	$0.0882	2026-10-21

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

$300.25

Highest Price

$1336.83

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00002-4117-30ZYPREXA 10MG TAB	$532.88	Big4	H2-Pharma, LLC	10/01/2026
00002-4117-30ZYPREXA 10MG TAB	$668.41	FSS	H2-Pharma, LLC	10/01/2026
61269-0630-30ZYPREXA 2.5MG TAB	$300.25	Big4	H2-Pharma, LLC	10/01/2026
61269-0630-30ZYPREXA 2.5MG TAB	$375.98	FSS	H2-Pharma, LLC	10/01/2026
61269-0631-30ZYPREXA 5MG TAB	$355.45	Big4	H2-Pharma, LLC	10/01/2026
61269-0631-30ZYPREXA 5MG TAB	$443.64	FSS	H2-Pharma, LLC	10/01/2026
61269-0635-30ZYPREXA 20MG TAB	$1094.83	Big4	H2-Pharma, LLC	10/01/2026
61269-0635-30ZYPREXA 20MG TAB	$1336.83	FSS	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 (2024)

Total Spending

$12.4M

Total Claims

8,883

Beneficiaries

1,208

Avg Cost/Unit

$29.03

Spending Trend

$18.8M(2019)→$18.5M(2020)→$17.3M(2021)→$16.0M(2022)→$15.5M(2023)→$12.4M(2024)

YoY Change:-8.2%

5yr CAGR:+1.4%

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

API Supply Chain26 active DMFs12 inactive

21 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 PHARMOVA 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

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

33 letters from Drugs@FDA

Date	Submission	Document
Feb 3, 2026	SUPPL -79	View Letter (PDF)
Feb 7, 2025	SUPPL -77	View Letter (PDF)
Apr 24, 2020	SUPPL -74	View Letter (PDF)
Apr 22, 2020	SUPPL -75	View Letter (PDF)
Oct 23, 2019	SUPPL -72	View Letter (PDF)
Mar 29, 2018	SUPPL -71	View Letter (PDF)
Mar 2, 2017	SUPPL -68	View Letter (PDF)
Mar 2, 2017	SUPPL -69	View Letter (PDF)
Oct 14, 2016	SUPPL -67	View Letter (PDF)
Dec 23, 2014	SUPPL -62	View Letter (PDF)
Jul 30, 2013	SUPPL -63	View Letter (PDF)
Jun 27, 2011	SUPPL -61	View Letter (PDF)
Jun 27, 2011	SUPPL -60	View Letter (PDF)
Dec 6, 2010	SUPPL -57	View Letter (PDF)
Jun 3, 2010	SUPPL -55	View Letter (PDF)
Jun 3, 2010	SUPPL -53	View Letter (PDF)
Feb 1, 2010	SUPPL -52	View Letter (PDF)
Jan 26, 2010	SUPPL -40	View Letter (PDF)
Jan 26, 2010	SUPPL -41	View Letter (PDF)
Nov 19, 2009	SUPPL -51	View Letter (PDF)
Aug 19, 2008	SUPPL -49	View Letter (PDF)
Jul 10, 2007	SUPPL -43	View Letter (PDF)
Jul 10, 2007	SUPPL -42	View Letter (PDF)
Dec 28, 2006	SUPPL -38	View Letter (PDF)
Sep 18, 2006	SUPPL -29	View Letter (PDF)
Mar 1, 2006	SUPPL -35	View Letter (PDF)
Feb 22, 2006	SUPPL -27	View Letter (PDF)
Feb 22, 2006	SUPPL -32	View Letter (PDF)
Sep 15, 2005	SUPPL -34	View Letter (PDF)
Aug 8, 2005	SUPPL -26	View Letter (PDF)
Jun 29, 2005	SUPPL -20	View Letter (PDF)
Jan 22, 2004	SUPPL -19	View Letter (PDF)
Jul 28, 2003	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 2.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 30, 1996

No patent or exclusivity listings for this strength.

#002 — 5MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1996

#003 — 7.5MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1996

#004 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1996

#005 — 15MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 9, 1997

#006 — 20MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 9, 1997