Viewing data from:

OLANZAPINE

ANDA

OLANZAPINE | A078109 | STRIDES PHARMA INTERNATIONAL AG

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ZYPREXA ZYDIS(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$0.7326

per ea

Lowest NADAC/Unit

$0.3231

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
64380017502OLANZAPINE ODT 20 MG TABLET	$0.7326	EA	Generic	—	2026-08-19
64380017402OLANZAPINE ODT 15 MG TABLET	$0.5786	EA	Generic	—	2026-08-19
64380017302OLANZAPINE ODT 10 MG TABLET	$0.3996	EA	Generic	—	2026-08-19
64380017202OLANZAPINE ODT 5 MG TABLET	$0.3231	EA	Generic	—	2026-08-19

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Oct 26, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 24, 2011

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 24, 2011

#003 — 15MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 24, 2011

#004 — 20MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 24, 2011