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Last Updated: April 15, 2025

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE Drug Patent Profile


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When do Olanzapine And Fluoxetine Hydrochloride patents expire, and what generic alternatives are available?

Olanzapine And Fluoxetine Hydrochloride is a drug marketed by Endo Operations, Epic Pharma Llc, and Teva Pharms. and is included in four NDAs.

The generic ingredient in OLANZAPINE AND FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

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Summary for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Drug patent expirations by year for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Recent Clinical Trials for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

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

SponsorPhase
First Affiliated Hospital of Chongqing Medical UniversityPhase 1/Phase 2
Second Xiangya Hospital of Central South UniversityPhase 1/Phase 2
First Affiliated Hospital of Zhejiang UniversityPhase 4

See all OLANZAPINE AND FLUOXETINE HYDROCHLORIDE clinical trials

Pharmacology for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

US Patents and Regulatory Information for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Teva Pharms OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 077528-001 Jun 19, 2012 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Endo Operations OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 077742-001 Nov 2, 2012 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Endo Operations OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 077742-004 Nov 2, 2012 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Epic Pharma Llc OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 078901-001 Nov 16, 2012 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Olanzapine and Fluoxetine Hydrochloride

Introduction

Olanzapine and fluoxetine hydrochloride, commonly known as the combination therapy Symbyax®, is a significant player in the treatment of mental health disorders, particularly bipolar I disorder and treatment-resistant depression. This article delves into the market dynamics and financial trajectory of this drug combination.

Market Size and Growth

The global olanzapine market, which includes olanzapine and fluoxetine hydrochloride combinations, has been experiencing steady growth. As of 2021, the global olanzapine market was valued at $1.8 billion and is projected to reach $2.2 billion by 2031, growing at a CAGR of 2.3% from 2022 to 2031[3].

Applications and Indications

Olanzapine and fluoxetine hydrochloride are primarily used for the treatment of:

  • Bipolar I Disorder: This combination is approved for the treatment of major depressive episodes associated with bipolar I disorder in adults and children aged 10 to 17 years[4].
  • Treatment-Resistant Depression: The combination therapy has shown efficacy in reducing health care utilization and medical costs for patients with treatment-resistant depression[5].

Market Segmentation

The market is segmented based on application, route of administration, and region.

  • Application: The schizophrenia segment dominated the global market in 2021, driven by the rise in incidences of mental illness. However, bipolar disorder and other applications also contribute significantly to the market[3].
  • Route of Administration: Olanzapine and fluoxetine are available in various forms, including tablets and orally disintegrating tablets[3].
  • Region: North America holds a major market share due to the high prevalence of schizophrenia and the presence of key market players. However, the Asia-Pacific region is expected to witness the highest growth rate during the forecast period due to increasing government initiatives and investments in healthcare infrastructure[3].

Key Market Players

The market is dominated by several key players, including:

  • Eli Lilly and Company
  • Aurobindo Pharma
  • Dr. Reddy’s Laboratories Ltd.
  • Novartis AG
  • Sun Pharmaceutical Industries Ltd.
  • Teva Pharmaceuticals Industries Ltd.
  • Viatris Inc.
  • Alkermes
  • Apotex Inc.[3].

Financial Performance

Historically, olanzapine, marketed as Zyprexa by Eli Lilly and Company, has been a significant contributor to the company's revenue. In 2004, despite challenges such as patent disputes and concerns over side effects, Zyprexa sales accounted for 32% of Lilly’s total net sales, contributing $9.7 billion to the company's revenue[2].

Impact of Side Effects and Legal Challenges

The financial trajectory of olanzapine and fluoxetine hydrochloride has been influenced by concerns over side effects such as weight gain, hyperglycemia, and metabolic syndrome. These concerns led to a decline in sales in the early 2000s and intense legal advertising targeting Zyprexa patients. However, the combination therapy has continued to find its place in the market due to its efficacy in treating severe mental health conditions[2][4].

Economic Impact

The combination therapy of olanzapine and fluoxetine has shown a positive economic impact by reducing health care utilization and medical costs. A study using claims data from a Fortune 100 manufacturer found a statistically significant reduction in health care utilization and overall medical costs by 20% following the initiation of olanzapine therapy in patients already on fluoxetine[5].

Government Initiatives and Healthcare Infrastructure

Government initiatives to improve healthcare infrastructure and increase awareness about mental health disorders have significantly boosted the market growth. In regions like Asia-Pacific, these initiatives have led to an increase in the number of drug stores and retail pharmacies, further driving the market[3].

Research and Development

Continuous research and development activities, including the approval of new indications and formulations, have been crucial for the market growth. For instance, the accelerated FDA approvals for new indications of drugs like Cymbalta and Alimta have set a precedent for similar approvals in the future, which could benefit the olanzapine and fluoxetine market[2].

COVID-19 Impact

The COVID-19 pandemic has highlighted the importance of mental health care, leading to an increased demand for antipsychotic and antidepressant medications. This surge in demand has contributed to the growth of the olanzapine market, despite some logistical challenges during the pandemic[3].

Future Outlook

The future outlook for the olanzapine and fluoxetine hydrochloride market is promising, driven by the rising incidence of mental health disorders and increasing government support for healthcare infrastructure. However, the market must navigate challenges such as high costs and side effects associated with the medication[3].

Key Takeaways

  • The global olanzapine market is projected to grow to $2.2 billion by 2031.
  • Olanzapine and fluoxetine hydrochloride combination therapy is crucial for treating bipolar I disorder and treatment-resistant depression.
  • North America holds a significant market share, but Asia-Pacific is expected to witness the highest growth rate.
  • Key market players include Eli Lilly and Company, Aurobindo Pharma, and others.
  • The combination therapy has a positive economic impact by reducing health care utilization and medical costs.

Frequently Asked Questions

Q: What is the projected market size of the global olanzapine market by 2031? A: The global olanzapine market is projected to reach $2.2 billion by 2031[3].

Q: What are the primary applications of olanzapine and fluoxetine hydrochloride combination therapy? A: The primary applications include the treatment of bipolar I disorder and treatment-resistant depression[4].

Q: Which region is expected to witness the highest growth rate for the olanzapine market? A: The Asia-Pacific region is expected to witness the highest growth rate during the forecast period[3].

Q: How has the COVID-19 pandemic impacted the olanzapine market? A: The pandemic has increased the demand for mental health care, contributing to the growth of the olanzapine market[3].

Q: What are some of the side effects associated with olanzapine and fluoxetine hydrochloride combination therapy? A: Side effects include weight gain, metabolic syndrome, QTc prolongation, and others[4].

Cited Sources

  1. Market Research Future: Olanzapine Market Size, Growth, Trends Report 2032.
  2. Annual Reports: Answers for Shareholders 2004 - Annual Reports.
  3. Allied Market Research: Olanzapine Market Size, Share | Report Forecast By 2031.
  4. FDA: Olanzapine and fluoxetine HCL Clinical PREA.
  5. PubMed: Economic impact of olanzapine plus fluoxetine combination therapy.

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