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Last Updated: May 8, 2021

DrugPatentWatch Database Preview

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, 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 Pharms Llc, Alkem Labs Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, Zydus Pharms, and Eli Lilly Co, and is included in forty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-three drug master file entries for olanzapine. Thirty-seven 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
Tan Tock Seng HospitalPhase 3
HCA Hospice CarePhase 2
Amani Hassan Abdel-WahabPhase 1/Phase 2

See all olanzapine clinical trials

Generic filers with tentative approvals for OLANZAPINE
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $105MGTABLET; 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
Apotex Inc OLANZAPINE olanzapine TABLET;ORAL 090798-005 Apr 23, 2012 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Hisun Pharm Hangzhou OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 206892-002 Dec 31, 2020 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Invagen Pharms OLANZAPINE olanzapine TABLET;ORAL 203333-001 Mar 15, 2016 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Torrent Pharms Llc OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 091415-001 Oct 25, 2011 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>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   Get Started for $10   Get Started for $10
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-001 Apr 6, 2000   Get Started for $10   Get Started for $10
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-004 Sep 30, 1996   Get Started for $10   Get Started for $10
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-003 Apr 6, 2000   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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