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Olanzapine - Generic Drug Details

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Olanzapine is the generic ingredient in four branded drugs marketed by Teva Pharms, Ivax Pharms Inc, Aurobindo Pharma Ltd, Par Pharm, Ajanta Pharma Ltd, Torrent Pharms Llc, Qilu Pharm Co Ltd, Jubilant Generics, Dr Reddys Labs Ltd, Invagen Pharms, Torrent Pharms Ltd, Orchid Hlthcare, Sun Pharm Inds, Luitpold, Barr Labs Inc, Macleods Pharms Ltd, Lilly, Apotex Inc, Mylan, Mylan Pharms Inc, Sandoz Inc, Alkem Labs Ltd, and Eli Lilly Co, and is included in thirty-three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-five patent family members in twenty-three countries.

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.

Summary for Generic Name: olanzapine

Tradenames:4
Patents:2
Applicants:23
NDAs:33
Drug Master File Entries: see list33
Suppliers / Packaging: see list45
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: olanzapine

Tentative approvals for OLANZAPINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL5MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ajanta Pharma Ltd
OLANZAPINE
olanzapine
TABLET;ORAL206711-006Aug 30, 2016RXNo► subscribe► subscribe
Mylan Pharms Inc
OLANZAPINE
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL202285-003May 12, 2014RXNo► subscribe► subscribe
Alkem Labs Ltd
OLANZAPINE
olanzapine
TABLET;ORAL202295-002Oct 20, 2015RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: olanzapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-002Sep 30, 19965,627,178*PED► subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-003Apr 6, 20005,736,541► subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-003Apr 6, 20005,457,895► subscribe
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International Patent Family for Ingredient: olanzapine

Country Document Number Estimated Expiration
China1154496► subscribe
South Africa200006815► subscribe
Australia761510► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: OLANZAPINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
70015Netherlands► subscribePRODUCT NAME: OLANZAPINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927
C0012Belgium► subscribePRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927
C/GB96/058United Kingdom► subscribePRODUCT NAME: OLANZAPINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/96/022/001 19960927; UK EU/1/96/022/002 19960927; UK EU/1/96/022/003 19960927; UK EU/1/96/022/004 19960927; UK EU/1/96/022/005 19960927; UK EU/1/96/022/006 19960927; UK EU/1/96/022/007 19960927; UK EU/1/96/022/008 19960927; UK EU/1/96/022/009 19960927; UK EU/1/96/022/010 19960927
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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 verifification 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.

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