You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Olanzapine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for olanzapine and what is the scope of freedom to operate?

Olanzapine is the generic ingredient in five branded drugs marketed by Am Regent, Aspiro, Eugia Pharma, Sandoz Inc, Cheplapharm, 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, and Alkermes Inc, and is included in forty-seven NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-three drug master file entries for olanzapine. Forty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for olanzapine

See drug prices for olanzapine

Drug Sales Revenue Trends for olanzapine

See drug sales revenues for olanzapine

Recent Clinical Trials for olanzapine

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

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

See all olanzapine clinical trials

Generic filers with tentative approvals for OLANZAPINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial5MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology 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
Torrent OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 091415-001 Oct 25, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd OLANZAPINE olanzapine TABLET;ORAL 202050-003 Apr 23, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd OLANZAPINE olanzapine TABLET;ORAL 076133-001 Apr 23, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cadila Pharms Ltd OLANZAPINE olanzapine TABLET;ORAL 210022-001 Feb 24, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hisun Pharm Hangzhou OLANZAPINE olanzapine TABLET;ORAL 206924-002 Dec 31, 2020 DISCN 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

Expired US Patents for olanzapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-004 Apr 6, 2000 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm ZYPREXA olanzapine TABLET;ORAL 020592-001 Sep 30, 1996 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-001 Apr 6, 2000 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-003 Apr 6, 2000 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-004 Apr 6, 2000 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm ZYPREXA olanzapine TABLET;ORAL 020592-006 Sep 9, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.