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Last Updated: March 1, 2024

OLANZAPINE Drug Patent Profile


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When do Olanzapine patents expire, and when can generic versions of Olanzapine launch?

Olanzapine is a drug marketed by Am Regent, Aspiro, Eugia Pharma, Sandoz Inc, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Chartwell Molecular, Dr Reddys Labs Ltd, Hec Pharm, Hisun Pharm Hangzhou, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orbion Pharms, Strides Pharma, Sun Pharm Inds, Torrent, Zydus Pharms, Alkem Labs Ltd, Cadila Pharms Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, Epic Pharma Llc, and Par Pharm. and is included in forty-six NDAs.

The generic ingredient in OLANZAPINE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

Drug patent expirations by year for OLANZAPINE
Drug Prices for OLANZAPINE

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Drug Sales Revenue Trends for OLANZAPINE

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Recent Clinical Trials for OLANZAPINE

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SponsorPhase
Response PharmaceuticalsPhase 1
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Christian HassagerPhase 3

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Pharmacology for OLANZAPINE
Anatomical Therapeutic Chemical (ATC) Classes for OLANZAPINE

US Patents and Regulatory Information for OLANZAPINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ajanta Pharma Ltd OLANZAPINE olanzapine TABLET;ORAL 206711-004 Aug 30, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Molecular OLANZAPINE olanzapine TABLET;ORAL 203333-003 Mar 15, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 203044-001 Feb 20, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hec Pharm OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 208146-004 Jul 2, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sunshine OLANZAPINE olanzapine TABLET;ORAL 206238-006 Nov 19, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds OLANZAPINE olanzapine TABLET;ORAL 091038-002 Apr 23, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc OLANZAPINE olanzapine TABLET;ORAL 090798-006 Apr 23, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for OLANZAPINE

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
Apotex Europe BV Olanzapine Apotex olanzapine EMEA/H/C/001178
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 2010-06-10
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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