ZYPREXA ZYDIS Drug Patent Profile

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

Zyprexa Zydis is a drug marketed by Cheplapharm and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zyprexa Zydis

A generic version of ZYPREXA ZYDIS was approved as olanzapine by SANDOZ INC on October 24^th, 2011.

Summary for ZYPREXA ZYDIS

US Patents:	0
Applicants:	1
NDAs:	1
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 ZYDIS
DailyMed Link:	ZYPREXA ZYDIS at DailyMed

See drug prices for ZYPREXA ZYDIS

Recent Clinical Trials for ZYPREXA ZYDIS

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 ZYDIS clinical trials

Pharmacology for ZYPREXA ZYDIS

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ZYPREXA ZYDIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-001	Apr 6, 2000	AB	RX	Yes	Yes
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	021086-003	Apr 6, 2000	AB	RX	Yes	No
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-004	Apr 6, 2000	AB	RX	Yes	No

Expired US Patents for ZYPREXA ZYDIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-004	Apr 6, 2000	6,251,895
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-003	Apr 6, 2000	5,627,178
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-003	Apr 6, 2000	5,605,897
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-001	Apr 6, 2000	6,251,895
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-001	Apr 6, 2000	5,817,656

EU/EMA Drug Approvals for ZYPREXA ZYDIS

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
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 ZYDIS

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	828	Process and crystal forms of 2-methyl-thieno-benzodiazepine.
Finland	971316
Ireland	68401	Pharmaceutical compounds
Slovenia	9620040	Postopek in kristalne oblike 2-metil-tieno-benzodiazepina (PROCESS AND CRYSTAL FORMS OF 2-METHYL-THIENO-BENZODIAZEPINE)
Yugoslavia	15499

Supplementary Protection Certificates for ZYPREXA ZYDIS

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 ZYDIS

Introduction to ZYPREXA ZYDIS

ZYPREXA ZYDIS, a formulation of the antipsychotic medication olanzapine, is designed as orally disintegrating tablets (ODTs) that dissolve rapidly in the mouth without the need for water. This unique formulation caters to patients with swallowing difficulties or those who prefer a more convenient and accessible dosage form.

Market Size and Growth

The global olanzapine market, which includes ZYPREXA ZYDIS, is projected to experience significant growth over the coming years. As of 2023, the global olanzapine market was valued at approximately USD 3.34 billion and is expected to grow at a compound annual growth rate (CAGR) of 2.5% from 2024 to 2030, reaching nearly USD 3.97 billion by 2030[5].

Segment Analysis by Product Type

Within the olanzapine market, ZYPREXA ZYDIS is a key segment. This segment emphasizes patient convenience, medication adherence, and treatment flexibility, which are crucial factors driving its adoption in psychiatric care settings worldwide. The orally disintegrating tablets offer immediate or rapid onset of olanzapine action, making them particularly useful in acute psychiatric episodes or emergency situations[1].

Applications and Demand

ZYPREXA ZYDIS is primarily used in the treatment of schizophrenia and bipolar disorder, among other neurological disorders. The increasing prevalence of these conditions, driven by a growing global population and inadequate mental health resources, contributes to the demand for olanzapine-based medications. According to WHO figures, the prevalence of mental health disorders is on the rise, with 10% of the global population affected, which further fuels the market growth[5].

Geographical Distribution

The market for ZYPREXA ZYDIS is distributed across various geographical regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. North America and Europe are significant markets due to their well-established healthcare systems and high awareness of mental health treatments. However, the Asia Pacific region is expected to show substantial growth due to increasing healthcare expenditure and a large patient population[1].

Financial Performance and Revenue Contribution

The financial performance of ZYPREXA ZYDIS is closely tied to the overall performance of the olanzapine market. In 2023, the sale of rights for the olanzapine portfolio, including ZYPREXA ZYDIS, contributed significantly to Eli Lilly's revenue. For instance, in Q3 2023, Eli Lilly reported a revenue increase of 37%, with $1.42 billion from the sale of rights for the olanzapine portfolio[2].

Competitive Landscape

The competitive landscape for ZYPREXA ZYDIS includes major pharmaceutical companies such as Eli Lilly and Company, the original developer of ZYPREXA, and generic manufacturers like Teva Pharmaceutical Industries Ltd. The market is highly competitive, with multiple players focusing on developing extended-release formulations and dose variations to optimize treatment outcomes and improve patient compliance[1].

Drivers and Opportunities

Several factors drive the growth of the ZYPREXA ZYDIS market:

• Increasing Prevalence of Mental Health Disorders: The rising prevalence of schizophrenia and bipolar disorder globally is a significant driver.
• Patient Convenience: The orally disintegrating tablets of ZYPREXA ZYDIS offer convenience and ease of administration, enhancing patient compliance.
• Emergency Use: The rapid onset of action makes ZYPREXA ZYDIS ideal for acute psychiatric episodes and emergency situations.
• Geographical Expansion: Growing healthcare expenditure in emerging markets presents opportunities for market expansion[1][5].

Challenges and Restraints

Despite the growth potential, the market for ZYPREXA ZYDIS faces several challenges:

• Generic Competition: The availability of generic olanzapine can reduce the market share of branded products like ZYPREXA ZYDIS.
• Regulatory Hurdles: Strict regulatory requirements and the need for continuous clinical trials can impact market growth.
• Side Effects and Safety Concerns: Olanzapine is associated with side effects such as weight gain and metabolic changes, which can affect patient adherence and market perception[1][5].

Financial Trajectory

The financial trajectory for ZYPREXA ZYDIS is positive, driven by the overall growth of the olanzapine market. Here are some key financial highlights:

• Revenue Growth: The global olanzapine market is expected to grow from USD 3.34 billion in 2023 to nearly USD 3.97 billion by 2030, indicating a steady revenue stream for ZYPREXA ZYDIS[5].
• Segment Contribution: ZYPREXA ZYDIS contributes significantly to the revenue of the olanzapine market, particularly due to its unique formulation and clinical utility in acute psychiatric care[1].

Key Takeaways

• Market Growth: The global olanzapine market, including ZYPREXA ZYDIS, is projected to grow at a CAGR of 2.5% from 2024 to 2030.
• Segment Importance: ZYPREXA ZYDIS is a crucial segment due to its convenience, rapid onset of action, and patient compliance benefits.
• Geographical Expansion: The market is expanding across various regions, with significant growth expected in the Asia Pacific.
• Competitive Landscape: The market is competitive, with both branded and generic players contributing to its dynamics.

FAQs

Q: What is ZYPREXA ZYDIS used for? A: ZYPREXA ZYDIS is used primarily for the treatment of schizophrenia and bipolar disorder. It is also useful in acute psychiatric episodes and emergency situations due to its rapid onset of action.

Q: How does ZYPREXA ZYDIS differ from other olanzapine formulations? A: ZYPREXA ZYDIS is an orally disintegrating tablet (ODT) that dissolves rapidly in the mouth without water, making it convenient for patients with swallowing difficulties.

Q: What is the expected market size of the global olanzapine market by 2030? A: The global olanzapine market is expected to reach nearly USD 3.97 billion by 2030, growing at a CAGR of 2.5% from 2024 to 2030[5].

Q: Which regions are significant for the ZYPREXA ZYDIS market? A: North America, Europe, and the Asia Pacific are significant regions for the ZYPREXA ZYDIS market, with the Asia Pacific expected to show substantial growth.

Q: Who are the major players in the ZYPREXA ZYDIS market? A: Major players include Eli Lilly and Company, the original developer of ZYPREXA, and generic manufacturers like Teva Pharmaceutical Industries Ltd.[1].

Cited Sources

1. Global Olanzapine Market Growth, Share, Size, Trends and Forecast (2024 - 2030) - Reanin Report Store
2. Lilly Reports Third-Quarter 2023 Financial Results, Highlights - Eli Lilly and Company Investor Relations
3. Eli Lilly and Company 2006 Annual Report - Eli Lilly and Company
4. Olanzapine Market Size, Growth, Trends Report 2032 - Market Research Future
5. Olanzapine Market - Global Industry Analysis and Forecast (2023 - 2029) - Maximize Market Research