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Last Updated: October 25, 2021

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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 freedom to operate?

Olanzapine is the generic ingredient in five branded drugs marketed by Am Regent, Aurobindo Pharma Ltd, Sandoz Inc, Lilly, Ajanta Pharma Ltd, Apotex Inc, Barr Labs Inc, Dr Reddys Labs Ltd, Hec Pharm, Hisun Pharm Hangzhou, Invagen Pharms, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Par Pharm, 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-eight 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
Chinese PLA General HospitalPhase 4
Anders Fink-Jensen, MD, DMSciPhase 4
HCA Hospice CarePhase 2

See all olanzapine clinical trials

Generic filers with tentative approvals for OLANZAPINE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free5MGTABLET; 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
Hec Pharm OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 208146-001 Jul 2, 2018 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Indoco OLANZAPINE olanzapine TABLET;ORAL 206155-006 Jul 31, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Ajanta Pharma Ltd OLANZAPINE olanzapine TABLET;ORAL 206711-001 Aug 30, 2016 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-005 Sep 9, 1997 ⤷  Try it Free ⤷  Try it Free
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-004 Apr 6, 2000 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
AstraZeneca
Colorcon
Medtronic
Dow

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 verification 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.