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Last Updated: July 13, 2024

ZYPREXA ZYDIS Drug Patent Profile


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Which patents cover Zyprexa Zydis, and what generic alternatives are available?

Zyprexa Zydis is a drug marketed by Cheplapharm and is included in one NDA.

The generic ingredient in ZYPREXA ZYDIS is olanzapine. There are thirty-three drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the olanzapine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Zyprexa Zydis

A generic version of ZYPREXA ZYDIS was approved as olanzapine by SANDOZ INC on October 24th, 2011.

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Drug patent expirations by year for ZYPREXA ZYDIS
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Recent Clinical Trials for ZYPREXA ZYDIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 2
Yale UniversityPhase 2

See all ZYPREXA ZYDIS clinical trials

Pharmacology for ZYPREXA ZYDIS

US Patents and Regulatory Information for ZYPREXA ZYDIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-001 Apr 6, 2000 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-004 Apr 6, 2000 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-002 Apr 6, 2000 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-003 Apr 6, 2000 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZYPREXA ZYDIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-003 Apr 6, 2000 ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-002 Apr 6, 2000 ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-001 Apr 6, 2000 ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-001 Apr 6, 2000 ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-004 Apr 6, 2000 ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-001 Apr 6, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ZYPREXA ZYDIS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eli Lilly Nederland B.V. Zyprexa Velotab olanzapine EMEA/H/C/000287
AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Authorised no no no 2000-02-03
Eli Lilly Nederland B.V. Zypadhera olanzapine EMEA/H/C/000890
Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
Authorised no no no 2008-11-19
Eli Lilly Nederland B.V. Zyprexa olanzapine EMEA/H/C/000115
Coated tabletsAdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.InjectionAdultsZyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.
Authorised no no no 1996-09-27
Krka Zalasta olanzapine EMEA/H/C/000792
Olanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Authorised yes no no 2007-09-27
Mylan Pharmaceuticals Limited Olanzapine Mylan olanzapine EMEA/H/C/000961
AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Authorised yes no no 2008-10-06
Teva B.V.  Olanzapine Teva olanzapine EMEA/H/C/000810
AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Authorised yes no no 2007-12-12
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ZYPREXA ZYDIS

See the table below for patents covering ZYPREXA ZYDIS around the world.

Country Patent Number Title Estimated Expiration
Georgia, Republic of P20032965 Pharmaceutical Compound ⤷  Sign Up
Canada 2265712 INTERMEDIAIRES ET PROCEDE DE PREPARATION DE L'OLANZAPINE (INTERMEDIATES AND PROCESS FOR PREPARING OLANZAPINE) ⤷  Sign Up
Slovenia 1095941 ⤷  Sign Up
Eurasian Patent Organization 200001218 ⤷  Sign Up
Argentina 002721 PROCESO PARA PREPARAR 2- METIL-4-(4-METIL-1-PIPERACINIL)-10H-TIENO [2,3-B][1,5]BENZODIACEPINA(OLANZAPINA) QUE CONTIENE MENOS DE 5 % DE SUBSTANCIAS RELACIONADAS INDESEABLES ⤷  Sign Up
Iceland 4564 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZYPREXA ZYDIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0454436 SPC/GB96/058 United Kingdom ⤷  Sign Up PRODUCT NAME: OLANZAPINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/96/022/001 19960927; UK EU/1/96/022/002 19960927; UK EU/1/96/022/003 19960927; UK EU/1/96/022/004 19960927; UK EU/1/96/022/005 19960927; UK EU/1/96/022/006 19960927; UK EU/1/96/022/007 19960927; UK EU/1/96/022/008 19960927; UK EU/1/96/022/009 19960927; UK EU/1/96/022/010 19960927
0454436 C970015 Netherlands ⤷  Sign Up PRODUCT NAME: OLANZAPINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927
0454436 9/1997 Austria ⤷  Sign Up PRODUCT NAME: OLANZAPIN ODER EIN SAEUREADDITIONSSALZ HIEVON; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927
0454436 97C0012 Belgium ⤷  Sign Up PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927
0454436 CA 2001 00042 Denmark ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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