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Last Updated: November 21, 2019

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OLANZAPINE Drug Profile

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When do Olanzapine patents expire, and when can generic versions of Olanzapine launch?

Olanzapine is a drug marketed by Am Regent, Sandoz Inc, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Dr Reddys Labs Ltd, Hec Pharm, Invagen Pharms, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Par Pharm, Sun Pharm Inds, Torrent Pharms Llc, Alkem Labs Ltd, Hikma Pharms, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu Pharm Co Ltd, Sunshine Lake, Teva Pharms, Torrent Pharms Ltd, Zydus Pharms, and Sandoz. and is included in thirty-nine NDAs.

The generic ingredient in OLANZAPINE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

Drug patent expirations by year for OLANZAPINE
Drug Prices for OLANZAPINE

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Drug Sales Revenue Trends for OLANZAPINE

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Recent Clinical Trials for OLANZAPINE

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SponsorPhase
Augusta UniversityPhase 4
CR-CSSS Champlain-Charles-Le MoynePhase 3
Corcept TherapeuticsPhase 1

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Recent Litigation for OLANZAPINE

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District Court Litigation
Case NameDate
ALCON MANUFACTURING, LTD v. APOTEX INC.2006-11-15
Bayer AG v. Dr. Reddy's Lab.Ltd.2004-03-24
ELI LILLY AND COMPANY v. ZENITH GOLDLINE PHARMACEUTICALS, INC.

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Pharmacology for OLANZAPINE
Paragraph IV (Patent) Challenges for OLANZAPINE
Tradename Dosage Ingredient NDA Submissiondate
ZYPREXA TABLET;ORAL olanzapine 020592
ZYPREXA ZYDIS TABLET, ORALLY DISINTEGRATING;ORAL olanzapine 021086

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
Apotex Inc OLANZAPINE olanzapine TABLET;ORAL 090798-002 Apr 23, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Ivax Pharms Inc OLANZAPINE olanzapine TABLET;ORAL 077301-001 Apr 29, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 202285-003 May 12, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Generics OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 200221-002 Sep 12, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 202074-001 Mar 25, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 077742-001 Nov 2, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd OLANZAPINE olanzapine TABLET;ORAL 076255-004 Apr 23, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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