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Last Updated: December 11, 2024

Olanzapine - Generic Drug Details

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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, Natco Pharma, 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-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for olanzapine

US Patents:	13
Tradenames:	5
Applicants:	33
NDAs:	47
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	147
Clinical Trials:	503
Patent Applications:	7,746
Drug Prices:	Drug price trends for olanzapine
Drug Sales Revenues:	Drug sales revenues for olanzapine
What excipients (inactive ingredients) are in olanzapine?	olanzapine excipients list
DailyMed Link:	olanzapine at DailyMed

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

Sponsor	Phase
Minerva Neurosciences	Phase 1
Simon Williamson Clinic	Phase 2
Helsinn Healthcare SA	Phase 2

See all olanzapine clinical trials

Generic filers with tentative approvals for OLANZAPINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	5MG	TABLET; 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

Drug Class	Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for olanzapine

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for olanzapine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Macleods Pharms Ltd	OLANZAPINE	olanzapine	TABLET;ORAL	202862-001	Aug 15, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Orbion Pharms	OLANZAPINE	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	202937-002	Mar 2, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	OLANZAPINE	olanzapine	TABLET;ORAL	202050-005	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		Y		⤷ Sign Up
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Natco Pharma	OLANZAPINE	olanzapine	TABLET;ORAL	076866-004	Apr 23, 2012		DISCN	No	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	021086-002	Apr 6, 2000	⤷ Sign Up	⤷ Sign Up
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	⤷ Sign Up	⤷ Sign Up
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-004	Sep 30, 1996	⤷ Sign Up	⤷ Sign Up
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-001	Apr 6, 2000	⤷ Sign Up	⤷ Sign Up
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for olanzapine

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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

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