Is there a generic for Olanzapine?

Yes. The FDA Orange Book lists 46 approved generic (ANDA) applications for Olanzapine, referencing the brand ZYPREXA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Olanzapine?

ZYPREXA (NDA 021253, CHEPLAPHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Olanzapine are approved?

Olanzapine is approved in the following dosage forms: powder, tablet, tablet, orally disintegrating.

FDA Orange Book · active-ingredient family

Olanzapine

Olanzapine: 3 brands, 46 generics; first approved Sep 30, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 46 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

200

Originator applications

Brand (NDA) products

ZYPREXARLDRS

CHEPLAPHARMNDA 0212532004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAMUSCULAR	Rx	AP

ZYPREXA ZYDISRLDRS

CHEPLAPHARMNDA 02108620004 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

ZYPREXARLD

CHEPLAPHARMNDA 02059219966 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (46)

OLANZAPINE

ANTHEA PHARMAANDA 2203232026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAMUSCULAR	Rx	AP

OLANZAPINE

OMNIVIUM PHARMSANDA 2190482026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAMUSCULAR	Rx	AP

OLANZAPINE

UBIANDA 2110722025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAMUSCULAR	Rx	AP

OLANZAPINE

QILUANDA 2181162025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAMUSCULAR	Rx	AP

OLANZAPINE

ASPIROANDA 2174662023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAMUSCULAR	Rx	AP

OLANZAPINE

ZYDUS PHARMSANDA 20288920234 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—

OLANZAPINE

CADILA PHARMS LTDANDA 21002220236 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

HISUN PHARM HANGZHOUANDA 20689220204 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

HISUN PHARM HANGZHOUANDA 20692420206 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
7.5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
15MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

OLANZAPINE

EUGIA PHARMAANDA 2109682020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAMUSCULAR	Rx	AP

OLANZAPINE

INDOCOANDA 20615520206 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
7.5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
15MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

OLANZAPINE

SUNSHINEANDA 20623820186 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

JIANGSU HANSOH PHARMANDA 20939920183 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—

OLANZAPINE

ZYDUS PHARMSANDA 09045920186 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

HEC PHARMANDA 20814620184 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

HIKMAANDA 20486620176 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
7.5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
15MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

OLANZAPINE

AJANTA PHARMA LTDANDA 20432020174 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—

OLANZAPINE

AJANTA PHARMA LTDANDA 20671120166 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
7.5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
15MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

OLANZAPINE

CHARTWELL MOLECULARANDA 20345620164 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

CHARTWELL MOLECULARANDA 20333320166 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

QILUANDA 20431920166 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

ALKEM LABS LTDANDA 20229520156 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

IVAX PHARMS INCANDA 0773012015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—

OLANZAPINE

ORBION PHARMSANDA 20293720154 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

MACLEODS PHARMS LTDANDA 20304420154 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

MACLEODS PHARMS LTDANDA 20286220146 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

AUROBINDO PHARMA LTDANDA 20370820144 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

PHARMOBEDIENTANDA 20228520144 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

JUBILANT GENERICSANDA 20022120124 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

APOTEX INCANDA 09079820126 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

AUROBINDO PHARMA LTDANDA 20205020126 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

DR REDDYS LABS LTDANDA 07625520124 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

OLANZAPINE

DR REDDYS LABS LTDANDA 07613320122 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

NATCO PHARMAANDA 07686620126 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
7.5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
15MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

OLANZAPINE

ORBION PHARMSANDA 20228720126 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

SUN PHARM INDSANDA 09103820126 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
7.5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
15MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

OLANZAPINE

TORRENT PHARMS LTDANDA 09143420126 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
15MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

OLANZAPINE

AM REGENTANDA 2017412012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAMUSCULAR	Rx	AP

OLANZAPINE

SUN PHARM INDSANDA 09088120124 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—

OLANZAPINE

BARR LABS INCANDA 07724320124 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

TORRENTANDA 09141520114 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

SANDOZ INCANDA 2015882011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAMUSCULAR	Rx	AP

OLANZAPINE

APOTEX INCANDA 09126520114 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

DR REDDYS LABS LTDANDA 07653420114 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

STRIDES PHARMA INTLANDA 07810920114 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
10MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
15MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
20MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

OLANZAPINE

TEVA PHARMSANDA 07600020115 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
7.5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
15MG	TABLET	ORAL	Discontinued	—

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Sep 30, 1996

30 yr 3 mo ago

Most recent approval

Mar 05, 2026

4 mo ago

Approvals span 1996–2026 across 49 FDA applications.

Brand (NDA) 36%

Generic (ANDA) 4694%

Olanzapine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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