LIBERVANT Drug Patent Profile

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

Libervant is a drug marketed by Aquestive and is included in one NDA. There is one patent protecting this drug.

This drug has twenty patent family members in eight countries.

The generic ingredient in LIBERVANT is diazepam. There are eight drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the diazepam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Libervant

A generic version of LIBERVANT was approved as diazepam by MYLAN on September 4^th, 1985.

Summary for LIBERVANT

International Patents:	20
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	4,074
What excipients (inactive ingredients) are in LIBERVANT?	LIBERVANT excipients list
DailyMed Link:	LIBERVANT at DailyMed

Pharmacology for LIBERVANT

Drug Class

Benzodiazepine

US Patents and Regulatory Information for LIBERVANT

LIBERVANT is protected by one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aquestive	LIBERVANT	diazepam	FILM;BUCCAL	218623-001	Apr 26, 2024		RX	Yes	No	11,273,131		Y
Aquestive	LIBERVANT	diazepam	FILM;BUCCAL	218623-004	Apr 26, 2024		RX	Yes	No	11,273,131		Y
Aquestive	LIBERVANT	diazepam	FILM;BUCCAL	218623-002	Apr 26, 2024		RX	Yes	No

International Patents for LIBERVANT

See the table below for patents covering LIBERVANT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	7431724
Japan	2024012484	増強された透過を有する医薬組成物
Canada	3076815	COMPOSITIONS PHARMACEUTIQUES A PERMEATION AMELIOREE (PHARMACEUTICAL COMPOSITIONS WITH ENHANCED PERMEATION)

LIBERVANT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Libervant

Introduction to Libervant

Libervant, developed by Aquestive Therapeutics, is a buccal film formulation of diazepam, designed for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity, also known as seizure clusters or acute repetitive seizures. Here’s a detailed look at the market dynamics and financial trajectory of this innovative drug.

FDA Approval and Market Exclusivity

Libervant received tentative approval from the FDA in August 2022 for patients twelve years of age and older. However, its full approval is currently subject to an orphan drug market exclusivity block until January 2027, due to an FDA-approved nasal spray product by another company[1][4].

Expansion of Patient Population

Aquestive is working towards expanding Libervant's market presence to include patients between the ages of six to twelve. The company plans to file for FDA approval for this age group before the orphan drug market exclusivity block expires[2][4].

Commercial Launch and Distribution

Libervant has already been launched for patients between the ages of two and five, with plans to expand this launch further. Aquestive anticipates achieving national retail distribution capabilities by the fourth quarter of 2024. This expansion includes broadening Medicaid and commercial coverage, which is crucial since Medicaid accounts for up to 50% of prescriptions among this pediatric patient population[1][2].

Sales Force and Reimbursement Coverage

Aquestive has deployed a dedicated sales force to enhance Libervant's market presence. The company has also secured nationwide reimbursement coverage, positioning itself for continued growth in the market[2][4].

Financial Performance

The financial performance of Libervant is closely tied to Aquestive's overall revenue and expense structure.

Revenue Growth

In the second quarter of 2024, Aquestive saw a 52% increase in total revenues, partly driven by increases in license and royalty revenue. However, manufacture and supply revenue, which includes Libervant, decreased due to various factors such as changes in licensing agreements and product sales[5].

For the third quarter of 2024, total revenues increased by 4% compared to the same period in 2023, primarily due to increases in license and royalty revenue. Manufacture and supply revenue, which includes Libervant, decreased to $10.7 million from $11.4 million in the third quarter of 2023[2][4].

Expense Structure

Research and development expenses have increased due to clinical trial costs and product research expenses associated with Libervant and other pipeline products like Anaphylm. Selling, general, and administrative expenses have also risen, driven by increased commercial spending and regulatory fees related to the approval and commercial preparations for Libervant[2][4].

Guidance and Outlook

Aquestive's full-year 2024 financial guidance does not include any revenue from Libervant due to the ongoing market exclusivity block. However, the company expects total revenue to range between $57 million and $60 million, with a non-GAAP adjusted EBITDA loss of $20 million to $23 million[2].

Market Potential

Despite the current market exclusivity block, Libervant holds significant market potential. Once fully approved and launched for the broader patient population, it is expected to contribute substantially to Aquestive's revenue. The company believes that Libervant, along with other product candidates like Anaphylm, positions Aquestive for continued growth over the next several years[1][3].

Competitive Landscape

The competitive landscape for seizure treatments is complex, with various products already in the market. However, Libervant's unique buccal film formulation offers a convenient and potentially more effective treatment option for patients, which could differentiate it from existing treatments[1][4].

Patient Benefits

Libervant is designed to provide rapid and effective treatment for seizure clusters, which can be life-threatening. Its ease of administration and potential for better patient compliance make it a valuable addition to the treatment options available for epilepsy patients[1][4].

Key Takeaways

• Tentative FDA Approval: Libervant received tentative approval in August 2022 for patients twelve years and older.
• Market Exclusivity: Full approval is blocked until January 2027 due to an orphan drug market exclusivity.
• Expansion Plans: Aquestive plans to expand Libervant's market presence to include patients between six to twelve years old.
• Commercial Launch: National retail distribution is anticipated by the fourth quarter of 2024.
• Financial Impact: Revenue growth is expected once the market exclusivity block is lifted.
• Competitive Advantage: Unique buccal film formulation offers convenience and potential effectiveness.

FAQs

1. What is Libervant used for? Libervant is used for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity, or seizure clusters, in epilepsy patients.

2. What is the current status of FDA approval for Libervant? Libervant received tentative FDA approval in August 2022 for patients twelve years and older but is subject to an orphan drug market exclusivity block until January 2027.

3. When is national retail distribution of Libervant expected? National retail distribution of Libervant is anticipated by the fourth quarter of 2024.

4. How does Libervant's administration differ from other seizure treatments? Libervant is administered via a buccal film, which is placed inside the cheek, offering a convenient and potentially more effective treatment option.

5. What are the financial expectations for Libervant once it is fully approved? Once fully approved and launched, Libervant is expected to contribute significantly to Aquestive's revenue, positioning the company for continued growth.

Cited Sources

1. Aquestive Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update - Biospace
2. Aquestive Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update - GlobeNewswire
3. Aquestive Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update - Aquestive Therapeutics
4. Aquestive Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update - Biospace
5. Aquestive Therapeutics Reports Second Quarter 2024 Financial Results - Aquestive Therapeutics Investor Relations