OLANZAPINE - Generic Drug Details

What are the generic sources for olanzapine and what is the scope of patent protection?

Olanzapine is the generic ingredient in five branded drugs marketed by Am Regent, Aspiro, Eugia Pharma, Sandoz Inc, Cheplapharm, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Chartwell Molecular, Dr Reddys Labs Ltd, Hec Pharm, Hisun Pharm Hangzhou, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orbion Pharms, Strides Pharma, Sun Pharm Inds, Torrent, Zydus Pharms, Alkem Labs Ltd, Cadila Pharms Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Natco Pharma, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, and Alkermes Inc, and is included in forty-seven NDAs. There are thirteen 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. Forty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for OLANZAPINE

US Patents:	13
Tradenames:	5
Applicants:	33
NDAs:	47
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	147
Clinical Trials:	503
Patent Applications:	7,746
Drug Prices:	Drug price trends for OLANZAPINE
Drug Sales Revenues:	Drug sales revenues for OLANZAPINE
What excipients (inactive ingredients) are in OLANZAPINE?	OLANZAPINE excipients list
DailyMed Link:	OLANZAPINE at DailyMed

See drug prices for OLANZAPINE

See drug sales revenues for OLANZAPINE

Recent Clinical Trials for OLANZAPINE

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

Sponsor	Phase
Minerva Neurosciences	Phase 1
Simon Williamson Clinic	Phase 2
Helsinn Healthcare SA	Phase 2

See all OLANZAPINE clinical trials

Generic filers with tentative approvals for OLANZAPINE

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET; 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

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for OLANZAPINE

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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
Hisun Pharm Hangzhou	OLANZAPINE	olanzapine	TABLET;ORAL	206924-004	Dec 31, 2020		DISCN	No	No
Sunshine	OLANZAPINE	olanzapine	TABLET;ORAL	206238-005	Nov 19, 2018		DISCN	No	No
Aurobindo Pharma Ltd	OLANZAPINE	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	203708-002	May 15, 2014	AB	RX	No	No
Macleods Pharms Ltd	OLANZAPINE	olanzapine	TABLET;ORAL	202862-002	Aug 15, 2014	AB	RX	No	No
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No	8,778,960
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021		RX	Yes	No	9,126,977		Y

Expired US Patents for OLANZAPINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-004	Sep 30, 1996	5,817,657*PED
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997	5,919,485*PED
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-001	Sep 30, 1996	5,736,541*PED
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-003	Apr 6, 2000	5,605,897
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997	5,605,897*PED
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-001	Sep 30, 1996	5,627,178*PED

EU/EMA Drug Approvals for OLANZAPINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Zyprexa Velotab	olanzapine	EMEA/H/C/000287 AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.	Authorised	no	no	no	2000-02-03
Eli Lilly Nederland B.V.	Zypadhera	olanzapine	EMEA/H/C/000890 Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.	Authorised	no	no	no	2008-11-19
Eli Lilly Nederland B.V.	Zyprexa	olanzapine	EMEA/H/C/000115 Coated tabletsAdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.InjectionAdultsZyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.	Authorised	no	no	no	1996-09-27
Krka	Zalasta	olanzapine	EMEA/H/C/000792 Olanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.	Authorised	yes	no	no	2007-09-27
Mylan Pharmaceuticals Limited	Olanzapine Mylan	olanzapine	EMEA/H/C/000961 AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.	Authorised	yes	no	no	2008-10-06
Teva B.V.	Olanzapine Teva	olanzapine	EMEA/H/C/000810 AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.	Authorised	yes	no	no	2007-12-12

OLANZAPINE Market Analysis and Financial Projection Experimental

Olanzapine Market Dynamics and Financial Trajectory

Introduction to Olanzapine

Olanzapine is an atypical antipsychotic medication primarily used to manage schizophrenia and bipolar disorder. It works by modulating the effects of neurotransmitters like dopamine and serotonin in the brain, helping to stabilize mood and reduce symptoms such as hallucinations and delusions.

Market Size and Growth Projections

The olanzapine market is experiencing robust growth, driven by several key factors. As of 2023, the market was valued at USD 2.4 billion and is projected to surpass USD 3.6 billion by 2032, indicating a compound annual growth rate (CAGR) of 4.6%[1].

Regional Market Performance

• North America: This region led the market with substantial revenue of USD 864 million in 2023. The well-established healthcare infrastructure, surge in adoption of mental healthcare services, and an increase in the geriatric population contribute to its dominant position[1][4].
• Asia-Pacific: This region is projected to experience impressive growth, with an estimated CAGR of 5.2%. The increase in health awareness, development in healthcare infrastructure, and the rise in the number of hospitals equipped with advanced medical facilities are driving this growth[1][4].

Dominant Applications

• Schizophrenia: This remains the dominant application, accounting for 58% of the market share in 2023. The rise in prevalence of schizophrenia is a significant driver of the olanzapine market[1][4].
• Bipolar Disorder and Other Indications: Olanzapine is also used to treat bipolar disorder and, off-label, major depressive disorder when combined with other antidepressants. Its applications in treating agitation and irritability associated with various psychiatric conditions further expand its market reach[1].

Distribution Channels

• Hospital Pharmacies: These represented 26% of the distribution channel share in 2023. The preference for hospital pharmacies is due to the need for close monitoring and management of patients undergoing treatment with olanzapine[1].

Market Drivers

Growing Awareness and Diagnosis Rates of Mental Health Conditions

The global rise in awareness and improved diagnostic capabilities for mental health conditions are significantly boosting the olanzapine market. Enhanced screening and diagnosis contribute to higher prescription rates, driving market growth[1].

Development of Novel Formulations

The development of novel olanzapine formulations, such as long-acting injections (LAIs), offers significant market opportunities. These formulations enhance patient compliance and reduce side effects, making them a preferred option for treating non-adherent or partially adherent patients with schizophrenia[1][2].

Increased Prevalence of Mental Health Disorders

The projected increase in emotional illness and mental health issues is set to drive the expansion of the olanzapine market. Factors such as the rise in the number of mental disorder clinics and improvements in healthcare infrastructure further support this growth[3][4].

Cost-Effectiveness and Economic Impact

• Olanzapine Long-Acting Injection (LAI): Studies have shown that olanzapine-LAI is more effective and, although more costly, remains within acceptable cost-effective ranges compared to oral olanzapine and other LAI formulations. The estimated incremental cost per quality-adjusted life year (QALY) gained is around $26,824 compared to oral olanzapine[2].
• Comparison with Other Antipsychotics: Olanzapine has been compared to conventional agents like haloperidol, showing that while it may be more expensive, it can yield equivalent savings in other health costs, justifying its expenditures[5].

Market Trends

Enhanced Formulations for Elderly Patients

There is a trend towards developing enhanced formulations tailored for elderly patients, which is expected to drive market growth. These formulations aim to reduce side effects and improve compliance among older adults[3].

Patient Support Programs

The introduction of patient support programs is another notable trend. These programs help in managing the treatment regimen and side effects, thereby enhancing patient outcomes and market growth[3].

Digital Health Solutions

The exploration and implementation of digital health solutions are becoming increasingly important. These solutions can improve adherence, monitoring, and overall patient care, contributing to the market's expansion[3].

Regulatory Scrutiny and Monitoring

Heightened regulatory scrutiny and monitoring are expected to shape the market. This includes stricter guidelines for the approval and use of olanzapine, ensuring safety and efficacy[3].

Competitive Landscape

The olanzapine market is characterized by the presence of key players such as Alkermes, Apotex Inc., Dr. Reddy’s Laboratories Ltd., and Eli Lilly and Company. These companies are driving market growth through product innovations, strategic partnerships, and strong distribution networks[4].

Financial Trajectory

• Current Market Value: The olanzapine market was valued at USD 2.4 billion in 2023[1].
• Future Projections: It is expected to grow to USD 3.6 billion by 2032, with a CAGR of 4.6%[1].
• Regional Growth: The Asia-Pacific region is anticipated to register the highest CAGR during the forecast period, driven by increasing health awareness and improvements in healthcare infrastructure[1][4].

Key Takeaways

• The olanzapine market is driven by growing awareness and diagnosis rates of mental health conditions.
• Novel formulations like long-acting injections are enhancing patient compliance and reducing side effects.
• The market is expected to grow significantly, with the Asia-Pacific region showing the highest growth potential.
• Cost-effectiveness studies indicate that olanzapine-LAI is a viable treatment option despite higher costs.
• Market trends include the development of formulations for elderly patients, patient support programs, and the integration of digital health solutions.

FAQs

Q: What is the primary use of olanzapine? A: Olanzapine is primarily used to manage schizophrenia and bipolar disorder by modulating the effects of neurotransmitters like dopamine and serotonin in the brain.

Q: What is the projected market size of olanzapine by 2032? A: The olanzapine market is projected to surpass USD 3.6 billion by 2032, growing at a CAGR of 4.6% from 2023 to 2032[1].

Q: Which region is expected to show the highest growth in the olanzapine market? A: The Asia-Pacific region is anticipated to register the highest CAGR during the forecast period, driven by increasing health awareness and improvements in healthcare infrastructure[1][4].

Q: What are the key drivers of the olanzapine market? A: The key drivers include growing awareness and diagnosis rates of mental health conditions, development of novel formulations, and an increase in the prevalence of mental health disorders[1][3][4].

Q: How does olanzapine-LAI compare to oral olanzapine in terms of cost-effectiveness? A: Olanzapine-LAI is more effective and, although more costly, remains within acceptable cost-effective ranges compared to oral olanzapine, with an estimated incremental cost per QALY gained of around $26,824[2].

Sources

1. Acumen Research and Consulting - Olanzapine Market Size to Reach USD 3.6 Billion by 2032 growing at 4.6% CAGR - Exclusive Report by Acumen Research and Consulting.
2. PubMed - Cost-effectiveness of olanzapine long-acting injection in the treatment of patients with schizophrenia.
3. GII Research - Olanzapine Global Market Report 2024.
4. Allied Market Research - Olanzapine Market Expected to Reach USD 2.2 Billion by 2031.
5. JAMA Network - Effectiveness and Cost of Olanzapine and Haloperidol in the Treatment of Schizophrenia.