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Last Updated: August 8, 2020

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Olanzapine - Generic Drug Details

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What are the generic 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, 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-five 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
Tianjin Anding HospitalN/A
Rajavithi HospitalPhase 3
Fifth Affiliated Hospital, Sun Yat-Sen UniversityPhase 3

See all olanzapine clinical trials

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 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
Aurobindo Pharma Ltd OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 203708-001 May 15, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-004 Apr 6, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 203708-004 May 15, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Ivax Pharms Inc OLANZAPINE olanzapine TABLET;ORAL 077301-001 Apr 29, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex Inc OLANZAPINE olanzapine TABLET;ORAL 090798-006 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 olanzapine TABLET;ORAL 020592-002 Sep 30, 1996   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 020592-004 Sep 30, 1996   Start Trial   Start Trial
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 021086-004 Apr 6, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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