Olanzapine Patent Expiration

Olanzapine is Used for treating treatment-resistant depression in adults. It was first introduced by Cheplapharm Registration Gmbh in its drug Zyprexa on Sep 30, 1996. Another drug containing Olanzapine is Zyprexa Zydis. 36 different companies have introduced drugs containing Olanzapine.


Olanzapine Patents

Given below is the list of patents protecting Olanzapine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zyprexa US6960577 Combination therapy for treatment of refractory depression Nov 01, 2017

(Expired)

Cheplapharm
Zyprexa Zydis US6960577 Combination therapy for treatment of refractory depression Nov 01, 2017

(Expired)

Cheplapharm



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Olanzapine's patents.

Given below is the list recent legal activities going on the following patents of Olanzapine.

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 01 Nov, 2005 US6960577
Recordation of Patent Grant Mailed 01 Nov, 2005 US6960577
Issue Notification Mailed 12 Oct, 2005 US6960577
Receipt into Pubs 06 Oct, 2005 US6960577
Dispatch to FDC 05 Oct, 2005 US6960577
Application Is Considered Ready for Issue 13 Aug, 2005 US6960577
Issue Fee Payment Verified 05 Jul, 2005 US6960577
Issue Fee Payment Received 05 Jul, 2005 US6960577
Mail Examiner's Amendment 02 Jun, 2005 US6960577
Mail Notice of Allowance 02 Jun, 2005 US6960577


Olanzapine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Olanzapine:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Treatment of Tinnitus With Olanzapine University of Sao Paulo NA COMPLETED
(Sep 1, 2026)
PHASE1
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects Alkermes, Inc. NA ENROLLING BY INVITATION
(Aug 1, 2026)
PHASE3
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder Alkermes, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE3
Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial Roswell Park Cancer Institute NA RECRUITING
(Aug 1, 2026)
PHASE2
GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer University of Illinois at Chicago NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia University of Arizona NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer OHSU Knight Cancer Institute NA RECRUITING
(Jul 1, 2026)
PHASE2
A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Trial in Patients With Advanced Tumors Kantonsspital Winterthur KSW NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients Receiving Neoadjuvant/Preoperative Chemotherapy Blokhin's Russian Cancer Research Center NA RECRUITING
(Jun 1, 2026)
PHASE3
Intranasal Insulin and Olanzapine Study in Healthy Volunteers Centre for Addiction and Mental Health NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery Yale University NA COMPLETED
(May 1, 2026)
PHASE2
Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting Affiliated Hospital of Qinghai University NA RECRUITING
(Apr 1, 2026)
PHASE3


Olanzapine Generic API Manufacturers

Several generic applications have been filed for Olanzapine. The first generic version for Olanzapine was by Sandoz Inc and was approved on Oct 24, 2011. And the latest generic version is by Anthea Pharma Private Ltd and was approved on Mar 5, 2026.

Given below is the list of companies who have filed for Olanzapine generic, along with the locations of their manufacturing plants worldwide.


Olanzapine News

2025 Global Industry Analysis of Olanzapine (CAS 132539-06-1) - GlobeNewswire

13 Jan, 2026

New Lawsuit Claims Widely Used Medication Led to Patient's Breast Cancer - CounterPunch.org

13 Aug, 2025

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