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, 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 nine 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-nine suppliers are listed for this compound.

Summary for olanzapine

US Patents:	9
Tradenames:	5
Applicants:	31
NDAs:	44
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	483
Patent Applications:	6,877
Formulation / Manufacturing:	see details
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

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
Federal Research Institute of Pediatric Hematology, Oncology and Immunology	Phase 3
University of Pennsylvania	Phase 2
Shi Yanxia	Phase 3

See all olanzapine clinical trials

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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Glossary

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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
Zydus Pharms	OLANZAPINE	olanzapine	TABLET;ORAL	090459-006	Jul 16, 2018	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Dr Reddys Labs Ltd	OLANZAPINE	olanzapine	TABLET;ORAL	076255-002	Apr 23, 2012	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	021086-004	Apr 6, 2000	See Plans and Pricing	See Plans and Pricing
Lilly	ZYPREXA	olanzapine	TABLET;ORAL	020592-002	Sep 30, 1996	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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