ZYPREXA RELPREVV Drug Patent Profile

When do Zyprexa Relprevv patents expire, and when can generic versions of Zyprexa Relprevv launch?

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

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

Summary for ZYPREXA RELPREVV

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Patent Applications:	55
Drug Prices:	Drug price information for ZYPREXA RELPREVV
DailyMed Link:	ZYPREXA RELPREVV at DailyMed

See drug prices for ZYPREXA RELPREVV

US Patents and Regulatory Information for ZYPREXA RELPREVV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-001	Dec 11, 2009		RX	Yes	No
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-002	Dec 11, 2009		RX	Yes	No
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-003	Dec 11, 2009		RX	Yes	Yes

Expired US Patents for ZYPREXA RELPREVV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-003	Dec 11, 2009	5,229,382*PED
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-001	Dec 11, 2009	5,229,382*PED
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-003	Dec 11, 2009	6,169,084
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-002	Dec 11, 2009	6,169,084
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-002	Dec 11, 2009	5,229,382*PED

International Patents for ZYPREXA RELPREVV

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

Country	Patent Number	Title	Estimated Expiration
Norway	20001631
Slovenia	1468689
Spain	2221376
Eurasian Patent Organization	002580	ГОТОВАЯ ПРЕПАРАТИВНАЯ ФОРМА 2-МЕТИЛ-ТИЕНО-БЕНЗОДИАЗЕПИНА (2-METHYL-THIENO-BENZODIAZEPINE FORMULATION)
Brazil	9813228

Supplementary Protection Certificates for ZYPREXA RELPREVV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454436	97C0012	Belgium		PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927
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	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
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

ZYPREXA RELPREVV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZYPREXA RELPREVV

Introduction

ZYPREXA RELPREVV, a long-acting atypical antipsychotic developed by Eli Lilly, has been a significant player in the treatment of schizophrenia. This article delves into the market dynamics and financial trajectory of this drug, highlighting its performance, challenges, and future prospects.

Market Overview

The global olanzapine market, which includes ZYPREXA RELPREVV, is driven by several key factors. The increasing prevalence of mental health disorders, particularly schizophrenia, is a primary driver. As awareness about these conditions grows, so does the demand for effective treatments like olanzapine[3].

Product Profile

ZYPREXA RELPREVV is indicated for the treatment of schizophrenia and is administered via deep intramuscular gluteal injection. The drug has been evaluated in clinical trials, demonstrating its efficacy in managing schizophrenia symptoms. However, it comes with specific dosing recommendations and warnings, such as the risk of post-injection delirium/sedation syndrome[4].

Safety Concerns and Regulatory Environment

The FDA has closely monitored ZYPREXA RELPREVV due to safety concerns. In 2015, the FDA investigated two patient deaths that occurred after receiving injections of the drug. Although the study results were inconclusive, the FDA noted that the deaths could have been caused by rapid, delayed entry of the drug into the bloodstream. Despite these concerns, the FDA did not recommend new limits on the drug's use[1].

Financial Performance

The financial performance of ZYPREXA RELPREVV has been mixed. Following the genericization of the blockbuster ZYPREXA pill, ZYPREXA RELPREVV struggled to fill the gap. In 2014, the Zyprexa franchise saw a 13% drop in sales from 2013, with worldwide sales of $1 billion. However, the key patent for ZYPREXA RELPREVV did not expire until 2018, providing some room for growth during that period[1].

Competitive Landscape

The schizophrenia market is highly competitive, with several other long-acting antipsychotics vying for market share. Drugs like Abilify Maintena from Lundbeck and Otsuka, and Invega Sustenna from Johnson & Johnson, pose significant competition. For instance, Invega Sustenna has already achieved blockbuster sales, and a new three-month dosing option was granted priority review by the FDA in 2015[1].

Market Growth Drivers

The olanzapine market, including ZYPREXA RELPREVV, is expected to grow driven by several factors:

• Increasing Prevalence of Mental Health Disorders: The rising number of cases of mental abnormalities and disorders is a prime factor boosting the market growth[3].
• New Product Approvals: The approval of new products for chronic diseases is projected to augment sales growth[3].
• Growing Awareness and Early Diagnosis: Increased awareness about mental health diseases and the importance of early diagnosis will drive future market demand[3].
• Rising Disposable Incomes: The increase in disposable incomes and the willingness to spend more on healthcare will also contribute to market growth[3].

Financial Projections

The olanzapine market, which includes ZYPREXA RELPREVV, is projected to grow significantly. By 2032, the market is estimated to reach approximately $3.51 billion from $2.625 billion in 2024, with a compound annual growth rate (CAGR)[5].

Challenges and Competition

Despite the growth potential, ZYPREXA RELPREVV faces several challenges:

• Generic Competition: The genericization of the original ZYPREXA pill has significantly impacted sales of ZYPREXA RELPREVV.
• Safety Concerns: The drug's safety profile, particularly the risk of post-injection delirium/sedation syndrome, remains a concern.
• Competitive Products: Other long-acting antipsychotics, such as those from Teva, Lundbeck, Otsuka, and Johnson & Johnson, compete aggressively in the market[1][2].

Recent Market Developments

Teva Pharmaceutical Industries, for example, has recently launched UZEDY, a long-acting treatment for schizophrenia, which is expected to compete with ZYPREXA RELPREVV. Teva's Q2 2023 financial results showed promising growth in their innovative products, including UZEDY, which received positive feedback from healthcare professionals[2].

Key Takeaways

• Market Growth: The olanzapine market is expected to grow driven by increasing mental health disorders, new product approvals, and rising disposable incomes.
• Financial Performance: ZYPREXA RELPREVV has faced challenges post-genericization of the original ZYPREXA pill but retains some growth potential.
• Safety and Regulatory: The drug has safety concerns, but the FDA has not imposed new limits on its use.
• Competition: The market is highly competitive with other long-acting antipsychotics.

FAQs

What is ZYPREXA RELPREVV used for?

ZYPREXA RELPREVV is a long-acting atypical antipsychotic used for the treatment of schizophrenia. It is administered via deep intramuscular gluteal injection[4].

What are the safety concerns associated with ZYPREXA RELPREVV?

The drug is associated with the risk of post-injection delirium/sedation syndrome, which can cause sedation, including coma, and delirium[4].

How has the genericization of ZYPREXA affected ZYPREXA RELPREVV sales?

The genericization of the original ZYPREXA pill led to a significant drop in sales for the ZYPREXA franchise, including ZYPREXA RELPREVV[1].

What is the competitive landscape for ZYPREXA RELPREVV?

The market is highly competitive with other long-acting antipsychotics such as Abilify Maintena, Invega Sustenna, and UZEDY from Teva[1][2].

What are the projected growth drivers for the olanzapine market?

The market is expected to grow due to increasing mental health disorders, new product approvals, growing awareness and early diagnosis, and rising disposable incomes[3].

Sources

1. FDA lets Lilly's long-acting Zyprexa off the hook in patient deaths - FiercePharma
2. Teva Pharmaceutical Industries Ltd. Q2 2023 Financial Results - Teva Pharmaceutical Industries Ltd.
3. Olanzapine Market, Analysis 2031 | Growth Drivers | Innovation - BioSpace
4. ZYPREXA RELPREVV Label - FDA
5. Olanzapine Market Size, Share, Growth and Forecast 2032 - Credence Research