OLANZAPINE; SAMIDORPHAN L-MALATE - Generic Drug Details

What are the generic drug sources for olanzapine; samidorphan l-malate and what is the scope of freedom to operate?

Olanzapine; samidorphan l-malate is the generic ingredient in one branded drug marketed by Alkermes Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olanzapine; samidorphan l-malate has eighty-five patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for OLANZAPINE; SAMIDORPHAN L-MALATE

International Patents:	85
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	OLANZAPINE; SAMIDORPHAN L-MALATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OLANZAPINE; SAMIDORPHAN L-MALATE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for OLANZAPINE; SAMIDORPHAN L-MALATE

Drug Class	Atypical Antipsychotic Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for OLANZAPINE; SAMIDORPHAN L-MALATE

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

US Patents and Regulatory Information for OLANZAPINE; SAMIDORPHAN L-MALATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021		RX	Yes	Yes			Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021		RX	Yes	No
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No			Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No

Expired US Patents for OLANZAPINE; SAMIDORPHAN L-MALATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021

International Patents for OLANZAPINE; SAMIDORPHAN L-MALATE

Country	Patent Number	Title	Estimated Expiration
Australia	2005304950	4-Hydroxybenzomorphans
Finland	3446565
South Korea	20070085723	4-HYDROXYBENZOMORPHANS
European Patent Office	2608670

Supplementary Protection Certificates for OLANZAPINE; SAMIDORPHAN L-MALATE

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

OLANZAPINE; SAMIDORPHAN L-MALATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Olanzapine and Samidorphan L-Malate

Introduction

The combination of olanzapine and samidorphan L-malate, marketed as LYBALVI™, represents a significant advancement in the treatment of schizophrenia and bipolar I disorder. This article delves into the market dynamics and financial trajectory of this drug combination, highlighting its clinical benefits, market approval, and long-term impact.

Clinical Benefits of LYBALVI

LYBALVI combines olanzapine, an effective atypical antipsychotic, with samidorphan, a novel opioid antagonist. This combination is designed to mitigate the weight gain and metabolic dysfunctions associated with olanzapine use. Clinical trials have demonstrated that samidorphan significantly reduces olanzapine-induced weight gain and metabolic issues, making LYBALVI a more tolerable and sustainable treatment option[1][3][4].

Market Approval and Launch

LYBALVI was approved by the FDA on May 28, 2021, for the treatment of adults with schizophrenia and bipolar I disorder. This approval marked a crucial milestone for Alkermes Inc., the company behind the drug. The approval was based on several clinical trials that showed the efficacy and safety of the combination product[1][3][4].

Market Positioning

LYBALVI is positioned as a once-daily, oral atypical antipsychotic drug, offering a unique advantage over traditional antipsychotics due to its weight mitigation properties. This differentiation is critical in a market where medication-induced weight gain is a significant concern for patient adherence and overall health outcomes. The drug is available in fixed-dose combinations, with olanzapine doses ranging from 5 mg to 20 mg and a constant 10 mg dose of samidorphan[3][4].

Long-Term Safety and Efficacy

A recent long-term, open-label extension study demonstrated that LYBALVI is generally well-tolerated with stable body weight and metabolic profiles over up to four years of treatment. This study reinforced the safety profile established in previous trials and highlighted the durable symptom control provided by LYBALVI. More than one-third of the subjects completed four years of treatment, which is noteworthy given the average treatment persistency of less than six months for oral atypical antipsychotics[3].

Financial Trajectory

The financial trajectory of LYBALVI is closely tied to its clinical success and market acceptance. Here are some key financial aspects:

Revenue Potential

Given its unique benefits and FDA approval, LYBALVI has significant revenue potential. The drug addresses a critical need in the psychiatric treatment market, where weight gain and metabolic issues are major concerns. As more patients and healthcare providers become aware of LYBALVI's advantages, its market share is likely to grow.

Market Size

The global market for antipsychotic drugs is substantial, and LYBALVI is poised to capture a significant portion of this market. The drug's approval for both schizophrenia and bipolar I disorder expands its target patient population, further enhancing its revenue potential.

Competitive Landscape

LYBALVI competes in a crowded market dominated by established antipsychotic medications. However, its unique combination of olanzapine and samidorphan sets it apart, offering a compelling alternative for patients and healthcare providers seeking to mitigate weight gain and metabolic side effects. This differentiation is likely to drive market share gains over traditional antipsychotics.

Pricing Strategy

The pricing strategy for LYBALVI will be crucial in determining its financial success. Given its clinical benefits and the value it offers in terms of reduced side effects, LYBALVI is likely to be priced competitively with other atypical antipsychotics while reflecting its unique advantages.

Regulatory Environment

The regulatory environment plays a vital role in the financial trajectory of any pharmaceutical product. LYBALVI's FDA approval and the ongoing submission of long-term study results to peer-reviewed journals are positive indicators of its regulatory standing. However, the drug must continue to meet regulatory standards and guidelines to maintain its market position[3][4].

Patient Adherence and Compliance

Patient adherence to treatment is a critical factor in the financial success of any medication. LYBALVI's ability to mitigate weight gain and metabolic issues is expected to improve patient compliance, as these side effects are often barriers to long-term treatment adherence. Improved compliance can lead to better health outcomes and increased revenue through sustained treatment use[1][3][4].

Industry Expert Insights

Industry experts, such as Craig Hopkinson, M.D., Executive Vice President, Research & Development and Chief Medical Officer at Alkermes, have expressed optimism about LYBALVI's potential. "These data highlight the potential utility of LYBALVI as a foundational maintenance treatment option for people living with schizophrenia or bipolar I disorder and reinforce the safety profile of LYBALVI established in previous studies," Hopkinson noted[3].

Statistical Highlights

• Approval Date: May 28, 2021[1][3][4].
• Long-Term Study: Over one-third of subjects completed four years of treatment, demonstrating sustained treatment effect and tolerability[3].
• Weight Mitigation: Statistically significant reduction in weight gain compared to olanzapine alone[4].
• Market Indications: Approved for schizophrenia and bipolar I disorder, including acute treatment of manic or mixed episodes and maintenance monotherapy or as an adjunct to lithium or valproate[3][4].

Key Takeaways

• Clinical Benefits: LYBALVI mitigates weight gain and metabolic dysfunctions associated with olanzapine use.
• Market Approval: FDA-approved on May 28, 2021, for schizophrenia and bipolar I disorder.
• Long-Term Safety: Demonstrated stability in body weight and metabolic profiles over up to four years.
• Financial Potential: Significant revenue potential due to its unique benefits and market need.
• Regulatory Standing: Strong regulatory position with ongoing submissions to peer-reviewed journals.

FAQs

Q: What is LYBALVI, and how does it differ from traditional antipsychotics?

LYBALVI is a combination of olanzapine and samidorphan L-malate, designed to mitigate the weight gain and metabolic dysfunctions associated with olanzapine use. This differentiation sets it apart from traditional antipsychotics.

Q: What are the approved indications for LYBALVI?

LYBALVI is approved for the treatment of adults with schizophrenia and bipolar I disorder, including acute treatment of manic or mixed episodes and maintenance monotherapy or as an adjunct to lithium or valproate.

Q: How has LYBALVI performed in long-term studies?

LYBALVI has demonstrated sustained treatment effect and tolerability over up to four years, with stability in body weight and metabolic profiles.

Q: What is the pricing strategy for LYBALVI?

The pricing strategy for LYBALVI is expected to be competitive with other atypical antipsychotics, reflecting its unique clinical benefits.

Q: How does LYBALVI impact patient adherence?

LYBALVI's ability to mitigate weight gain and metabolic issues is expected to improve patient compliance, as these side effects are often barriers to long-term treatment adherence.

Sources

1. DrugBank Online: Samidorphan L-malate | DrugBank Online.
2. Regulations.gov: US Patent No. - Regulations.gov.
3. PR Newswire: Alkermes Announces Topline Results From Long-Term, Open-Label Safety and Durability of Treatment Effect Study of LYBALVI.
4. FDA: 213378Orig1s000 213378Orig2s000 - accessdata.fda.gov.