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Last Updated: July 13, 2024

OLANZAPINE - Generic Drug Details


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What are the generic sources for olanzapine and what is the scope of patent protection?

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 thirteen 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

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Drug Sales Revenue Trends for OLANZAPINE

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Recent Clinical Trials for OLANZAPINE

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

SponsorPhase
Helsinn Healthcare SAPhase 2
Simon Williamson ClinicPhase 2
Response PharmaceuticalsPhase 1

See all OLANZAPINE clinical trials

Generic filers with tentative approvals for OLANZAPINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5MGTABLET; 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
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
Chartwell Molecular OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 203456-004 Mar 16, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds OLANZAPINE olanzapine TABLET;ORAL 091038-005 Apr 23, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd OLANZAPINE olanzapine TABLET;ORAL 202050-003 Apr 23, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-004 May 28, 2021 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 OLANZAPINE

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 olanzapine TABLET;ORAL 020592-001 Sep 30, 1996 ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-002 Apr 6, 2000 ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA olanzapine TABLET;ORAL 020592-006 Sep 9, 1997 ⤷  Sign Up ⤷  Sign Up
Cheplapharm ZYPREXA olanzapine TABLET;ORAL 020592-002 Sep 30, 1996 ⤷  Sign Up ⤷  Sign Up
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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