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LYBALVI Drug Patent Profile

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

Lybalvi is a drug marketed by Alkermes Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has eighty-five patent family members in twenty-seven countries.

The generic ingredient in LYBALVI is olanzapine; samidorphan l-malate. 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; samidorphan l-malate profile page.

DrugPatentWatch^® Generic Entry Outlook for Lybalvi

Lybalvi will be eligible for patent challenges on May 28, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 30, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LYBALVI

International Patents:	85
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	1
Drug Prices:	Drug price information for LYBALVI
What excipients (inactive ingredients) are in LYBALVI?	LYBALVI excipients list
DailyMed Link:	LYBALVI at DailyMed

See drug prices for LYBALVI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LYBALVI

Constraining patent/regulatory exclusivity:

9,119,848

NDA:

213378

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.

Recent Clinical Trials for LYBALVI

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

Sponsor	Phase
Alkermes, Inc.	Phase 1

See all LYBALVI clinical trials

Pharmacology for LYBALVI

Drug Class	Atypical Antipsychotic Opioid Antagonist
Mechanism of Action	Opioid Antagonists

US Patents and Regulatory Information for LYBALVI

LYBALVI is protected by twenty US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,119,848.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	213378-002	May 28, 2021		RX	Yes	No	9,119,848			Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No	7,262,298			Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No	11,793,805
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	213378-003	May 28, 2021		RX	Yes	No	9,119,848			Y

Expired US Patents for LYBALVI

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	8,252,929
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	213378-004	May 28, 2021	7,956,187
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021	7,956,187
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021	7,956,187

International Patents for LYBALVI

When does loss-of-exclusivity occur for LYBALVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Croatia

Denmark

European Patent Office

Hungary

Japan

Lithuania

Montenegro

New Zealand

Poland

Portugal

Serbia

Slovenia

Spain

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LYBALVI around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2015038139	薬物過量摂取の治療のためのモルヒナン誘導体 (MORPHINAN DERIVATIVES FOR THE TREATMENT OF DRUG OVERDOSE)
Spain	2304477
World Intellectual Property Organization (WIPO)	0236573
Austria	E557006
Norway	20072839

Supplementary Protection Certificates for LYBALVI

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

LYBALVI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LYBALVI

Introduction to LYBALVI

LYBALVI, an oral atypical antipsychotic drug, is developed by Alkermes plc for the treatment of adults with schizophrenia and bipolar I disorder. This drug has been making significant waves in the pharmaceutical market, particularly in the seven major markets including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

Mechanism of Action and Clinical Use

LYBALVI works by modulating the activity of various neurotransmitters in the brain, which helps in managing symptoms of schizophrenia and bipolar I disorder. Its unique mechanism of action sets it apart from other antipsychotic medications, making it a valuable addition to the treatment options available for these conditions[4].

Market Scenario and Forecast

The market for LYBALVI is expected to undergo significant changes in the coming years. Extensive research and incremental healthcare spending globally are anticipated to expand the market size, enabling drug manufacturers to penetrate deeper into the market. This growth is driven by the increasing demand for effective treatments for schizophrenia and bipolar depression[1][4].

Emerging Therapies and Competition

The landscape for LYBALVI is not without challenges. Other emerging products for schizophrenia and bipolar depression are expected to provide tough market competition. The launch of late-stage emerging therapies in the near future will significantly impact the market dynamics, potentially influencing LYBALVI's dominance. Companies are focusing on novel approaches to treat these conditions, which could further intensify the competition[1][4].

Regulatory Milestones and Developmental Activities

LYBALVI has achieved several regulatory milestones, which are crucial for its market presence. Detailed descriptions of these milestones and ongoing developmental activities provide a clear picture of the drug's current development scenario. These activities include ongoing clinical trials, regulatory approvals, and other strategic initiatives aimed at enhancing the drug's efficacy and market position[1][4].

Financial Performance of LYBALVI

Quarterly Revenue Highlights

LYBALVI has shown robust financial performance in recent quarters. For the third quarter of 2024, LYBALVI revenues were $74.7 million, marking a significant increase from the previous year. This growth is part of a broader trend where LYBALVI revenues have been consistently rising, with a 52% increase in revenues and a 44% increase in total prescriptions in the second quarter of 2024 compared to the same period in the previous year[2][5].

Annual Revenue Trends

On an annual basis, LYBALVI's revenues have been steadily increasing. For instance, in the first nine months of 2024, LYBALVI revenues stood at $203.1 million, up from $135.7 million in the same period of the previous year. This growth reflects the drug's increasing acceptance and prescription rates in the market[2].

Impact on Alkermes plc's Financials

The success of LYBALVI has significantly contributed to Alkermes plc's overall financial performance. The company's total revenues, which include contributions from other proprietary products like VIVITROL and ARISTADA, have shown year-over-year growth. For the third quarter of 2024, Alkermes plc reported total revenues of $378.1 million, with LYBALVI being a key driver of this growth[2].

Profitability and Cash Flow

Alkermes plc's financial results also highlight the company's profitability and cash flow. The GAAP net income from continuing operations for the third quarter of 2024 was $92.8 million, and the non-GAAP net income from continuing operations was $121.4 million. These figures indicate that the company is managing its business to deliver significant profitability and cash flow while investing in strategic initiatives, including the advancement of its pipeline products like ALKS 2680[2].

Market Assessments and Forecast Analysis

Detailed market assessments and forecast analyses for LYBALVI are crucial for decision-making in the pharmaceutical industry. These analyses include SWOT analyses, analysts' views, and comprehensive overviews of market competitors. The forecasted sales data from 2023 to 2032 provides a clear picture of the drug's potential market trajectory, helping clients make informed decisions about their therapeutic portfolios[1][4].

Analysts' Views and Competitive Landscape

Analysts view LYBALVI as a significant player in the treatment of schizophrenia and bipolar I disorder. The competitive landscape is dynamic, with other emerging therapies posing potential challenges. However, LYBALVI's unique mechanism of action and its established market presence position it well to maintain a strong market share[1][4].

Conclusion

LYBALVI is a pivotal drug in the treatment of schizophrenia and bipolar I disorder, with a strong market presence and financial trajectory. The drug's growth is driven by increasing demand, extensive research, and incremental healthcare spending. While it faces competition from emerging therapies, LYBALVI's unique mechanism of action and regulatory milestones position it for continued success.

Key Takeaways

• Market Growth: The market for LYBALVI is expected to expand due to increasing demand and healthcare spending.
• Financial Performance: LYBALVI has shown significant revenue growth, contributing to Alkermes plc's overall financial success.
• Regulatory Milestones: The drug has achieved several regulatory milestones, enhancing its market position.
• Competition: LYBALVI faces competition from emerging therapies, but its unique mechanism of action is a strong differentiator.
• Forecast Analysis: Detailed market assessments and forecast analyses indicate a strong potential market trajectory for LYBALVI.

FAQs

What is LYBALVI used for?

LYBALVI is an oral atypical antipsychotic drug used for the treatment of adults with schizophrenia and bipolar I disorder.

Who developed LYBALVI?

LYBALVI was developed by Alkermes plc.

What are the key financial highlights for LYBALVI in recent quarters?

In the third quarter of 2024, LYBALVI revenues were $74.7 million, showing a significant increase from the previous year. The drug's revenues have been consistently rising, with a 52% increase in revenues and a 44% increase in total prescriptions in the second quarter of 2024.

How does LYBALVI impact Alkermes plc's financials?

LYBALVI is a key contributor to Alkermes plc's total revenues and profitability. The company's financial results reflect strong year-over-year growth driven by its proprietary commercial products, including LYBALVI.

What are the market challenges faced by LYBALVI?

LYBALVI faces competition from other emerging therapies for schizophrenia and bipolar depression. The launch of late-stage emerging therapies is expected to significantly impact the market dynamics.

Sources

1. ResearchAndMarkets.com: LYBALVI Market Drug Insight and Market Forecast - 2032
2. Alkermes plc: Third Quarter 2024 Financial Results
3. StockTitan.net: Alkermes plc Reports First Quarter 2024 Financial Results
4. PR Newswire: LYBALVI: An Oral Atypical Antipsychotic Drug for the Treatment of Adults with Schizophrenia and Bipolar I Disorder
5. PR Newswire: Alkermes plc Reports Second Quarter 2024 Financial Results