Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 11, 2019

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Olanzapine - Generic Drug Details

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What are the generic drug sources for olanzapine and what is the scope of patent protection?

Olanzapine is the generic ingredient in four branded drugs marketed by Am Regent, Sandoz Inc, Lilly, 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 Eli Lilly Co, and is included in thirty-nine NDAs. 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. There is one tentative approval for this compound.

Drug Prices for olanzapine

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Drug Sales Revenue Trends for olanzapine

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Recent Clinical Trials for olanzapine

Identify potential brand extensions & 505(b)(2) entrants

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

See all olanzapine clinical trials

Recent Litigation for olanzapine

Identify potential future generic entrants

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.

See all olanzapine litigation

Generic filers with tentative approvals for OLANZAPINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MGTABLET; 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
Paragraph IV (Patent) Challenges for OLANZAPINE
Tradename Dosage Ingredient NDA Submissiondate
ZYPREXA ZYDIS TABLET, ORALLY DISINTEGRATING;ORAL olanzapine 021086
ZYPREXA TABLET;ORAL olanzapine 020592

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
Dr Reddys Labs Ltd OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 076534-001 Oct 24, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Jiangsu Hansoh Pharm OLANZAPINE olanzapine TABLET;ORAL 209399-003 Sep 24, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-003 Sep 30, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds OLANZAPINE olanzapine TABLET;ORAL 091038-006 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

Expired US Patents for olanzapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-002 Apr 6, 2000   Start Trial   Start Trial
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-002 Apr 6, 2000   Start Trial   Start Trial
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-003 Sep 30, 1996   Start Trial   Start Trial
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-004 Sep 30, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.