ZYPREXA Drug Patent Profile

Which patents cover Zyprexa, and what generic alternatives are available?

Zyprexa is a drug marketed by Cheplapharm and is included in four NDAs.

The generic ingredient in ZYPREXA is olanzapine pamoate. There are thirty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the olanzapine pamoate profile page.

Summary for ZYPREXA

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	147
Clinical Trials:	130
Patent Applications:	4,698
Drug Prices:	Drug price information for ZYPREXA
What excipients (inactive ingredients) are in ZYPREXA?	ZYPREXA excipients list
DailyMed Link:	ZYPREXA at DailyMed

See drug prices for ZYPREXA

See drug sales revenues for ZYPREXA

Recent Clinical Trials for ZYPREXA

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

Sponsor	Phase
Oregon Health and Science University	Phase 2
OHSU Knight Cancer Institute	Phase 2
Yale University	Phase 2

See all ZYPREXA clinical trials

Pharmacology for ZYPREXA

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ZYPREXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	AB	RX	Yes	No
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997	AB	RX	Yes	No
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-002	Apr 6, 2000	AB	RX	Yes	No
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-004	Apr 6, 2000	AB	RX	Yes	No
Cheplapharm	ZYPREXA	olanzapine	INJECTABLE;INTRAMUSCULAR	021253-001	Mar 29, 2004	AP	RX	Yes	Yes
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-001	Dec 11, 2009		RX	Yes	No

Expired US Patents for ZYPREXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-005	Sep 9, 1997	5,817,655*PED
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997	5,627,178*PED
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-004	Sep 30, 1996	5,919,485*PED
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997	5,736,541*PED
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	5,627,178*PED
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	5,605,897*PED

EU/EMA Drug Approvals for ZYPREXA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
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
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
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
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
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
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

International Patents for ZYPREXA

See the table below for patents covering ZYPREXA around the world.

Country	Patent Number	Title	Estimated Expiration
Estonia	03551	Tahke oraalne preparaat, mis sisaldab toimeainena olansapiini, selle valmistamismeetod ja kasutamine
Eurasian Patent Organization	000149	СПОСОБ ПОЛУЧЕНИЯ 2-МЕТИЛ-ТИЕНОБЕНЗОДИАЗЕПИНА И ЕГО КРИСТАЛЛИЧЕСКИЕ ФОРМЫ (PROCESS AND CRYSTAL FORMS OF 2-METHYL-THIENOBENZODIAZEPINE)
Germany	69714165
Iceland	4564
Israel	139592	PHARMACEUTICAL COMPOSITION CONTAINING AN ATYPICAL ANTIPSYCHOTIC AND A SEROTONIN REUPTAKE INHIBITOR FOR COMBINATION THERAPY OF REFRACTORY DEPRESSION
Norway	20005885

Supplementary Protection Certificates for ZYPREXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454436	9/1997	Austria		PRODUCT NAME: OLANZAPIN ODER EIN SAEUREADDITIONSSALZ HIEVON; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927
0454436	97C0012	Belgium		PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927
0454436	C970015	Netherlands		PRODUCT NAME: OLANZAPINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927
0454436	CA 2001 00042	Denmark
0454436	SPC/GB96/058	United Kingdom		PRODUCT NAME: OLANZAPINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/96/022/001 19960927; UK EU/1/96/022/002 19960927; UK EU/1/96/022/003 19960927; UK EU/1/96/022/004 19960927; UK EU/1/96/022/005 19960927; UK EU/1/96/022/006 19960927; UK EU/1/96/022/007 19960927; UK EU/1/96/022/008 19960927; UK EU/1/96/022/009 19960927; UK EU/1/96/022/010 19960927

Market Dynamics and Financial Trajectory for ZYPREXA (Olanzapine)

Introduction

ZYPREXA, also known as olanzapine, is a widely used antipsychotic medication primarily employed in the treatment of schizophrenia, bipolar disorder, and major depressive disorder. The market for olanzapine has been experiencing significant dynamics driven by various factors, including increasing mental health awareness, advancements in psychiatric treatments, and shifts in market ownership.

Market Size and Growth

The global olanzapine market has been growing steadily. In 2023, the market size was valued at $2.55 billion and is expected to reach $2.62 billion in 2024, with a compound annual growth rate (CAGR) of 3.1%[1].

By 2028, the market is projected to grow to $2.93 billion at a CAGR of 2.8%, driven by factors such as increasing mental health awareness, innovation in psychiatric medications, and global mental health initiatives[1].

Regional Market Performance

North America has been the largest region in the olanzapine market, largely due to the high prevalence of psychiatric illnesses and the presence of major biopharmaceutical companies. However, the Asia-Pacific region is expected to be the fastest-growing during the forecast period, driven by increasing government initiatives to promote mental health and the expansion of drug stores and retail pharmacies[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the olanzapine market:

• Increasing Prevalence of Mental Health Disorders: The rise in mental health disorders such as schizophrenia and bipolar disorder is a significant driver. For instance, the World Health Organization estimates that mental disorders will cost the global economy an estimated $6.0 trillion by 2030[3].
• Growing Awareness and Diagnosis: Enhanced awareness and diagnosis of mental health issues are leading to more patients seeking treatment, thereby increasing the demand for olanzapine[1][3].
• Advancements in Psychiatric Treatments: Innovations in psychiatric medications, including enhanced formulations for elderly patients and the introduction of patient support programs, are contributing to market growth[1].
• Global Mental Health Initiatives: Initiatives aimed at improving mental health services and increasing access to antipsychotic medications are also driving the market forward[1].

Market Trends

Several trends are shaping the future of the olanzapine market:

• Enhanced Formulations: There is a focus on developing formulations that are more suitable for elderly patients, which is expected to increase the market's appeal[1].
• Patient Support Programs: The introduction of patient support programs is aimed at improving adherence to treatment and overall patient outcomes[1].
• Regulatory Scrutiny: Increased regulatory scrutiny and monitoring are expected to impact the market, ensuring higher standards of safety and efficacy[1].
• Digital Health Solutions: The exploration of digital health solutions is another trend, potentially enhancing the delivery and management of antipsychotic treatments[1].

Recent Market Transactions

In April 2023, Cheplapharm Arzneimittel GmbH acquired the worldwide commercial rights for ZYPREXA from Eli Lilly and Company, marking a significant shift in the market ownership. This acquisition strengthened Cheplapharm's portfolio in the central nervous system therapeutic area[1].

Financial Performance of Key Players

Eli Lilly and Company, the previous owner of the ZYPREXA portfolio, reported significant financial impacts from the sale of these rights. In Q3 2023, Eli Lilly's revenue increased by 37%, partly due to the $1.42 billion revenue from the sale of the olanzapine portfolio. Excluding this revenue, the company's total revenue still increased by 24%[5].

In Q3 2024, Eli Lilly reported a 20% increase in worldwide revenue, driven by volume growth from other products like Mounjaro and Zepbound, but partially offset by the absence of revenue from the olanzapine portfolio[2].

Competitive Landscape

The olanzapine market is competitive, with several key players involved:

• Eli Lilly and Company: Although they have sold the commercial rights, they remain a significant player in the pharmaceutical industry.
• Cheplapharm Arzneimittel GmbH: The new owner of the ZYPREXA commercial rights.
• Other Players: Companies like Alkermes, Apotex Inc., Aurobindo Pharma, Dr. Reddy’s Laboratories Ltd., Novartis AG, Sun Pharmaceutical Industries Ltd., Teva Pharmaceuticals Industries Ltd., and Viatris Inc. are also major participants in the market[1][4].

Challenges and Limitations

Despite the growth, the olanzapine market faces challenges such as side effects associated with antipsychotic drugs, including weight gain, increased cholesterol levels, and the risk of diabetes. These side effects can hamper market growth and necessitate ongoing research into safer and more efficient treatments[4].

Future Outlook

The future of the olanzapine market looks promising, driven by increasing demand for antipsychotic medications, technological advancements, and growing awareness of mental health issues. However, the market will need to navigate regulatory scrutiny and the ongoing need for safer and more effective treatments.

Key Takeaways

• The olanzapine market is growing steadily, driven by increasing mental health awareness and advancements in psychiatric treatments.
• North America is the largest market, but the Asia-Pacific region is expected to grow the fastest.
• Recent transactions, such as the acquisition by Cheplapharm, have reshaped the market landscape.
• Key players are focusing on enhanced formulations, patient support programs, and digital health solutions.
• Despite growth, the market faces challenges related to side effects and regulatory scrutiny.

FAQs

What is the current market size of olanzapine?

The global olanzapine market size was valued at $2.55 billion in 2023 and is expected to reach $2.62 billion in 2024[1].

Which region is expected to be the fastest-growing in the olanzapine market?

The Asia-Pacific region is expected to be the fastest-growing during the forecast period, driven by increasing government initiatives and the expansion of drug stores and retail pharmacies[1][4].

What are the key drivers of the olanzapine market growth?

Key drivers include the increasing prevalence of mental health disorders, growing awareness and diagnosis, advancements in psychiatric treatments, and global mental health initiatives[1][3].

Who are the major players in the olanzapine market?

Major players include Eli Lilly and Company, Cheplapharm Arzneimittel GmbH, Alkermes, Apotex Inc., Aurobindo Pharma, Dr. Reddy’s Laboratories Ltd., Novartis AG, Sun Pharmaceutical Industries Ltd., Teva Pharmaceuticals Industries Ltd., and Viatris Inc.[1][4].

What are the challenges faced by the olanzapine market?

Challenges include side effects such as weight gain, increased cholesterol levels, and the risk of diabetes, as well as regulatory scrutiny and the need for ongoing research into safer and more effective treatments[4].

Sources

1. The Business Research Company, "Olanzapine Market Report 2024"
2. Eli Lilly and Company, "Lilly reports Q3 2024 financial results highlighted by strong volume growth"
3. Fortune Business Insights, "Antipsychotic Drugs Market Size, Share | Growth [2024-2032]"
4. Allied Market Research, "Olanzapine Market Size, Share | Report Forecast By 2031"
5. Eli Lilly and Company, "Lilly Reports Third-Quarter 2023 Financial Results, Highlights"