Olanzapine; samidorphan l-malate - Generic Drug Details

What are the generic sources for olanzapine; samidorphan l-malate and what is the scope of patent protection?

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

Olanzapine; samidorphan l-malate has eighty-nine patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for olanzapine; samidorphan l-malate

International Patents:	89
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for olanzapine; samidorphan l-malate
DailyMed Link:	olanzapine; samidorphan l-malate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for olanzapine; samidorphan l-malate

Constraining patent/regulatory exclusivity:

9,119,848

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

Paragraph IV (Patent) Challenges for OLANZAPINE; SAMIDORPHAN L-MALATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYBALVI	Tablets	olanzapine; samidorphan l-malate	5 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg	213378	3	2025-05-28

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	213378-003	May 28, 2021		RX	Yes	No	11,351,166
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021		RX	Yes	Yes
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	9,517,235
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021		RX	Yes	No	9,126,977		Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021		RX	Yes	Yes	12,194,035
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; samidorphan l-malate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021	7,956,187
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021	8,252,929
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021	7,262,298
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021	8,252,929
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021	7,262,298
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021	8,252,929
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021	7,956,187

International Patents for olanzapine; samidorphan l-malate

Country	Patent Number	Title	Estimated Expiration
Norway	340204
Denmark	2251330
Denmark	2506712
Australia	2018202410
Russian Federation	2007120759	4-ГИДРОКСИБЕНЗОМОРФАНЫ
South Korea	20070085723	4-HYDROXYBENZOMORPHANS
Poland	3446565

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

Market dynamics and financial trajectory for the pharmaceutical drug: olanzapine; samidorphan l-malate

Last updated: July 30, 2025

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Introduction

The combination of olanzapine and samidorphan l-malate has garnered significant attention in the pharmaceutical landscape, primarily owing to its potential to address unmet clinical needs in psychiatric disorders such as schizophrenia and bipolar disorder. This article explores the market dynamics, regulatory environment, competitive landscape, and financial trajectory associated with this innovative therapy, focusing on factors influencing its commercial success and strategic positioning.

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Pharmacological Profile and Therapeutic Promise

Olanzapine, a widely used atypical antipsychotic, is approved for schizophrenia and bipolar I disorder. Its efficacy is tempered by notable metabolic side effects such as weight gain and diabetes risk. Samidorphan l-malate, an opioid antagonist, has been studied for its ability to mitigate these metabolic adverse effects when combined with olanzapine. The fixed-dose combination aims to preserve antipsychotic efficacy while improving tolerability, thereby broadening its therapeutic window and adherence potential.

This pharmacological synergy underpins the drug's attractiveness. The combination’s potential to reduce common olanzapine-associated metabolic issues aligns with evolving clinical guidelines emphasizing holistic patient management and tolerability.

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Market Dynamics

Unmet Clinical Need and Patient Demographics

Schizophrenia affects approximately 20 million people worldwide, with bipolar disorder impacting an estimated 45 million globally [1]. Despite the availability of various antipsychotics, treatment adherence remains a challenge, driven by side effects—particularly weight gain and metabolic syndrome.

The olanzapine-samidorphan combination addresses this gap, offering a promising alternative that caters to patients intolerant to metabolic side effects of existing therapies. Its ability to enhance adherence and quality of life could expand the patient population eligible for successful pharmacotherapy.

Regulatory Milestones and Approvals

The drug’s path to market hinges on regulatory approvals. Notably, LYBALVI™ (olanzapine and samidorphan) received FDA approval in the United States in 2021 for schizophrenia and bipolar I disorder [2]. This marks an essential validation, enabling commercialization and access to a large clinical population. Regulatory bodies have reviewed data emphasizing its efficacy and safety, though post-marketing surveillance remains critical.

Regionally, approvals in Europe, Asia, and emerging markets are under consideration, influenced by local regulatory pathways and unmet needs. Market access strategies are vital, considering differing health policies and reimbursement landscapes.

Market Adoption Drivers and Barriers

Drivers include:

• Improved metabolic side-effect profile
• Enhanced adherence owing to better tolerability
• Broader clinical acceptance, supported by robust efficacy data

Barriers include:

• Competition from established atypical antipsychotics (risperidone, aripiprazole, quetiapine)
• Cost considerations, especially in markets prioritizing generic availability
• Prescriber familiarity, requiring educational initiatives to shift established treatment paradigms

Competitive Landscape

The psychiatric drug market is highly competitive, with numerous pharmacological options demonstrating comparable efficacy but variable side-effect profiles. Competitors include:

• Olanzapine monotherapy
• Other atypical antipsychotics with metabolic profile advantages (e.g., aripiprazole)
• Novel agents under development targeting metabolic effects (e.g., fosmetpantotenate)

The unique selling proposition (USP) of the olanzapine-samidorphan combination lies in its integrated approach to efficacy and tolerability, potentially providing a differentiated positioning.

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Financial Trajectory and Commercial Outlook

Market Size and Revenue Estimates

The global antipsychotic drug market was valued at approximately USD 9.7 billion in 2021, projected to grow at a CAGR of 3-4% through 2030 [3]. Olanzapine accounts for a significant share within this segment, with the development of combination therapies poised to further expand it.

The financial prospects for olanzapine-samidorphan hinge on:

• Market penetration rates influenced by efficacy, safety, and prescriber acceptance.
• Pricing strategies balancing value demonstration and market accessibility.
• Reimbursement policies fostering adoption, especially in healthcare systems prioritizing metabolic safety.

Industry analysts forecast the revenue potential for such combination therapies to reach USD 1-2 billion globally within the next five years. Significant revenue streams will emerge from North America, where mental health disorders incur substantial treatment expenditures, and Europe, where regulatory approval has been granted.

Pricing and Reimbursement Considerations

Premium pricing may be justified given the drug’s clinical benefits; however, reimbursement frameworks could challenge uptake, especially in price-sensitive markets. Demonstrating cost-effectiveness through health economics studies is pivotal to gain favorable reimbursement decisions and optimize formulary placements.

Pipeline and Expansion Opportunities

Expanding indications (e.g., treatment-resistant schizophrenia, adjunctive therapy in depression) and formulations (e.g., long-acting injectables, generic versions) can significantly influence financial trajectories. Strategic partnerships or licensing agreements may catalyze market penetration, especially in emerging economies.

Additionally, ongoing clinical trials exploring the combination's efficacy in other neuropsychiatric disorders could unlock new revenue streams, bolstering the long-term financial outlook.

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Regulatory and Market Challenges

Patent Lifespan and Generic Competition

Patent protection for key formulations might expire within the next 5-8 years, risking generic competition. Strategic patent strengthening, including formulation patents and combination-specific exclusivities, is critical to sustain margins.

Post-Marketing Surveillance and Safety

Monitoring for rare adverse events critical to long-term safety will influence market perception and revenue. Any safety concerns may prompt formulary restrictions, affecting financial performance.

Market Penetration Strategies

Companies must navigate physician education, clinical practice behaviors, and reimbursement hurdles. Effective engagement and evidence dissemination are essential to propel adoption and financial success.

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Global Market Considerations

In mature markets like the US and Europe, the focus is on market share acquisition and optimizing reimbursement. In emerging economies, regulatory approvals, cost considerations, and infrastructure for mental health care are pivotal.

Partnerships with local pharmaceutical firms can accelerate access, while tiered pricing models may facilitate broader reach in low-income regions.

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Key Takeaways

• The olanzapine-samidorphan combination addresses critical unmet needs in psychiatric treatment, emphasizing metabolic safety.
• Early regulatory approval in key markets signals strong commercial potential, contingent on effective market penetration.
• Competition from existing antipsychotics and generics necessitates strategic differentiation, emphasizing efficacy and safety profiles.
• Revenue projections are optimistic, with potential for USD 1-2 billion in global sales within five years, driven by expanding indications and geographic reach.
• Navigating patent landscapes, reimbursement challenges, and safety surveillance will be critical to sustaining long-term financial success.

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FAQs

1. How does samidorphan complement olanzapine’s clinical profile?
Samidorphan acts as an opioid antagonist, counteracting olanzapine-induced weight gain and metabolic disturbances, thereby improving overall tolerability without compromising efficacy.

2. What is the regulatory status of olanzapine-samidorphan combination products?
The FDA approved LYBALVI™ (olanzapine and samidorphan) for schizophrenia and bipolar I disorder in 2021. Other regions are reviewing or have approved similar formulations based on regional clinical data.

3. What are the main competitive advantages of this combination therapy?
Its primary advantage lies in mitigating common metabolic side effects associated with olanzapine, potentially improving adherence and treatment outcomes—a significant differentiation over monotherapy options.

4. What are the financial risks associated with this new combination?
Risks include patent expiration leading to generic competition, market acceptance hurdles, and reimbursement challenges, which could impact revenue realization.

5. How might future clinical developments influence this drug’s market trajectory?
Positive results in additional indications or expanded formulations could significantly enhance the drug’s market size, while safety issues or failed trials could dampen growth prospects.

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References

[1] World Health Organization. "Mental health: strengthening our response," 2019.
[2] U.S. Food and Drug Administration. "FDA approves new medication for schizophrenia and bipolar disorder," 2021.
[3] MarketsandMarkets. "Antipsychotic Drugs Market - Global Forecast to 2030," 2022.