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Serving leading biopharmaceutical companies globally:

Moodys
Farmers Insurance
Novartis
Cantor Fitzgerald
Merck
Dow
UBS
Citi
McKesson
Fish and Richardson

Generated: November 25, 2017

DrugPatentWatch Database Preview

Olanzapine - Generic Drug Details

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What are the generic drug sources for olanzapine and what is the scope of olanzapine freedom to operate?

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, Hikma Pharms, Mylan Pharms Inc, Sandoz Inc, Alkem Labs Ltd, and Eli Lilly Co, and is included in thirty-five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olanzapine has twenty-six patent family members in twenty-three countries and three supplementary protection certificates in three countries.

There are thirty-three drug master file entries for olanzapine. Forty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for olanzapine

Tentative approvals for OLANZAPINE

Applicant Application No. Strength Dosage Form
u► Subscribe5MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Pharms
OLANZAPINE
olanzapine
TABLET;ORAL204866-004Jun 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-001Apr 6, 2000ABRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
OLANZAPINE
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL202285-002May 12, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
OLANZAPINE
olanzapine
TABLET;ORAL076866-006Apr 23, 2012DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-003Sep 30, 1996ABRXYesNo► Subscribe► Subscribe ► Subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-002Apr 6, 2000ABRXYesNo► Subscribe► Subscribe ► Subscribe
Barr Labs Inc
OLANZAPINE
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL077243-003Jan 30, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Alkem Labs Ltd
OLANZAPINE
olanzapine
TABLET;ORAL202295-004Oct 20, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Ajanta Pharma Ltd
OLANZAPINE
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL204320-003May 30, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Orchid Hlthcare
OLANZAPINE
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL202937-001Mar 2, 2015ABRXNoNo► Subscribe► 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;ORAL020592-003Sep 30, 1996► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-001Sep 30, 1996► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-006Sep 9, 1997► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-005Sep 9, 1997► Subscribe► Subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-003Apr 6, 2000► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-001Sep 30, 1996► Subscribe► Subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-003Apr 6, 2000► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-005Sep 9, 1997► Subscribe► Subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-004Apr 6, 2000► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-003Sep 30, 1996► Subscribe► Subscribe
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International Patent Family for Ingredient: olanzapine

Country Document Number Estimated Expiration
Hong Kong1040055► Subscribe
Norway20005885► Subscribe
Eurasian Patent Organization200001218► Subscribe
CroatiaP20000797► Subscribe
Malaysia127938► Subscribe
Slovakia17512000► Subscribe
World Intellectual Property Organization (WIPO)9961027► Subscribe
South Africa200006815► Subscribe
Australia4008699► Subscribe
Indonesia26861► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Cantor Fitzgerald
Merck
Fuji
Daiichi Sankyo
Deloitte
Express Scripts
Teva
QuintilesIMS

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