Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Dow
McKesson
Merck
Baxter

Last Updated: January 30, 2023

Olanzapine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, Eugia Pharma, Sandoz Inc, Lilly, 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, Alkem Labs Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, Zydus Pharms, Eli Lilly Co, and Alkermes Inc, and is included in forty-four NDAs. There are ten 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. Thirty-eight 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
Tianjin Anding HospitalPhase 4
Rigshospitalet, DenmarkN/A
The Guthrie ClinicPhase 4

See all olanzapine clinical trials

Generic filers with tentative approvals for OLANZAPINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing5MGTABLET; 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
Sunshine OLANZAPINE olanzapine TABLET;ORAL 206238-003 Nov 19, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms OLANZAPINE olanzapine TABLET;ORAL 090459-001 Jul 16, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hisun Pharm Hangzhou OLANZAPINE olanzapine TABLET;ORAL 206924-003 Dec 31, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Barr Labs Inc OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 077243-002 Jan 30, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-003 Apr 6, 2000 See Plans and Pricing See Plans and Pricing
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-003 Sep 30, 1996 See Plans and Pricing See Plans and Pricing
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-002 Apr 6, 2000 See Plans and Pricing See Plans and Pricing
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-003 Sep 30, 1996 See Plans and Pricing See Plans and Pricing
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
AstraZeneca
Colorcon
Medtronic
Dow

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.