SYMPAZAN Drug Patent Profile

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

Sympazan is a drug marketed by Otter Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and sixty-eight patent family members in nineteen countries.

The generic ingredient in SYMPAZAN is clobazam. There are ten drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the clobazam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sympazan

A generic version of SYMPAZAN was approved as clobazam by AMNEAL on October 22^nd, 2018.

Summary for SYMPAZAN

International Patents:	168
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Patent Applications:	4,144
Drug Prices:	Drug price information for SYMPAZAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMPAZAN
What excipients (inactive ingredients) are in SYMPAZAN?	SYMPAZAN excipients list
DailyMed Link:	SYMPAZAN at DailyMed

See drug prices for SYMPAZAN

Pharmacology for SYMPAZAN

Drug Class	Benzodiazepine
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for SYMPAZAN

SYMPAZAN is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018		RX	Yes	No	11,541,002		Y
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018		RX	Yes	Yes	11,541,002		Y
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018		RX	Yes	No	11,541,002		Y

Expired US Patents for SYMPAZAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018	8,603,514
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018	8,603,514
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018	8,603,514

International Patents for SYMPAZAN

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2332523	Films uniformes pour la forme de dosage de dissolution rapide incorporant des compositions de masquage du goût (Uniform films for rapid dissolve dosage form incorporating taste-masking compositions)
European Patent Office	3210601	FILMS À BASE D'OXYDE DE POLYÉTHYLÈNE ET SYSTÈMES D'ADMINISTRATION DE MÉDICAMENT FABRIQUÉS À PARTIR DE CEUX-CI (POLYETHYLENE OXIDE-BASED FILMS AND DRUG DELIVERY SYSTEM MADE THEREFROM)
Australia	2006287342	Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions

Market Dynamics and Financial Trajectory for Sympazan

Introduction

Sympazan, a clobazam oral film formulation, has been a significant player in the pharmaceutical market, particularly for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS). Developed and initially commercialized by Aquestive Therapeutics, this drug has undergone several key developments that have impacted its market dynamics and financial trajectory.

Product Overview

Sympazan is indicated for the adjunctive treatment of seizures associated with LGS in patients aged 2 years and older. It was launched in December 2018 as an alternative to traditional tablet or liquid suspension forms of clobazam, addressing the specific needs of LGS patients who often have difficulty swallowing pills or large volume suspensions[3][4].

Market Performance

Revenue Growth

In 2021, Sympazan saw a significant increase in revenue. For the full year, Sympazan net revenue increased by 51% compared to the prior year, despite market access limitations due to COVID-19 and the Omicron variant. This growth was a key contributor to Aquestive Therapeutics' total revenue, which increased by 11% from $45.8 million in 2020 to $50.8 million in 2021[1].

Quarterly Performance

In the fourth quarter of 2021, Sympazan net revenue increased by 77% compared to the same period in 2020. This robust growth was part of the overall increase in Aquestive's total revenues, which rose by 55% from $7.1 million to $11.1 million during the same period[1].

Licensing and Acquisitions

Assertio Holdings Acquisition

In October 2022, Assertio Holdings, Inc. acquired an exclusive license for Sympazan from Aquestive Therapeutics for an upfront payment of $9.0 million, with additional payments of $6.0 million upon patent allowance. This transaction was part of Assertio's strategy to diversify its product portfolio and leverage its non-personal digital platform to enhance Sympazan's market presence[4].

Strategic Impact

The acquisition by Assertio is expected to extend the patent life of Sympazan, potentially up to 2039, and aligns with Assertio's growth plans. Sympazan is anticipated to contribute significantly to Assertio's goal of achieving $40 million in gross profit by 2024[4].

Financial Trajectory

Revenue Projections

As of the trailing 12 months ended June 30, 2022, Sympazan generated approximately $9.5 million in revenue. Assertio expects Sympazan to add around 20% to their gross profit goal by 2024, indicating a positive financial outlook for the product[4].

Cost and Expense Management

Aquestive Therapeutics' financial reports show that while Sympazan's revenue has been increasing, the company has also managed to reduce certain costs and expenses. For instance, in the first quarter of 2022, Aquestive saw a decrease in interest expense and non-cash interest expense related to the KYNMOBI royalty monetization transaction, which helped offset higher costs and expenses[5].

Net Loss and EBITDA

Despite the revenue growth, Aquestive Therapeutics reported a net loss for the full year 2021 of $70.5 million, or $1.85 loss per share, which was influenced by a one-time non-cash loss on extinguishment of debt. However, the non-GAAP Adjusted EBITDA loss improved from $32.9 million in 2020 to $24.9 million in 2021, reflecting better operational efficiency[1].

Market Dynamics

Competitive Landscape

Sympazan competes in a market where generic film-based products have gained significant traction. For example, generic film products for buprenorphine-naloxone have penetrated the market, reducing the market share of branded products like Suboxone. However, Sympazan's unique oral film formulation and low carbohydrate content provide it with a competitive edge, especially for LGS patients on restricted carbohydrate diets[3].

Regulatory Environment

The regulatory environment continues to play a crucial role in Sympazan's market dynamics. The product's patent protection, which could extend up to 2039, provides a significant barrier to entry for generic competitors. Additionally, any changes in FDA regulations or approvals can impact the product's market position and revenue potential[4].

Future Outlook

Growth Initiatives

Assertio Holdings is focused on internal growth initiatives and business development transactions to maximize the value of Sympazan. This includes enhancing commercial and channel strategies, investing in digital promotion programs, and improving payor coverage and patient access[2].

R&D and Pipeline Development

Aquestive Therapeutics continues to invest in research and development, including the development of AQST-109, which is expected to accelerate in 2022. While Sympazan is a key product, the company's pipeline development is crucial for long-term growth and market sustainability[1].

Key Takeaways

• Revenue Growth: Sympazan has shown significant revenue growth, with a 51% increase in 2021 and a 77% increase in the fourth quarter of 2021.
• Licensing and Acquisitions: Assertio Holdings acquired an exclusive license for Sympazan, aiming to extend its patent life and enhance market presence.
• Financial Performance: Despite revenue growth, Aquestive Therapeutics reported net losses, but improved EBITDA performance indicates better operational efficiency.
• Market Dynamics: Sympazan's unique formulation and regulatory protections provide a competitive edge, but the market is subject to generic competition and regulatory changes.
• Future Outlook: Assertio is focused on growth initiatives, and Aquestive continues to invest in R&D to sustain long-term market presence.

FAQs

What is Sympazan used for?

Sympazan is used for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients aged 2 years and older[4].

Who acquired the exclusive license for Sympazan?

Assertio Holdings, Inc. acquired the exclusive license for Sympazan from Aquestive Therapeutics in October 2022[4].

What was the upfront payment for the Sympazan license?

Assertio paid an upfront payment of $9.0 million, with additional payments of $6.0 million upon patent allowance[4].

How has Sympazan's revenue performed?

Sympazan's revenue increased by 51% in 2021 and by 77% in the fourth quarter of 2021 compared to the prior year periods[1].

What is the potential patent life extension for Sympazan?

The patent life for Sympazan could be extended up to 2039, providing significant protection against generic competition[4].

Sources

1. Aquestive Therapeutics Reports Full Year 2021 Results Exceeding Revenue and EBITDA Guidance. Aquestive Therapeutics.
2. Assertio-IR-Overview-March-2023. Assertio Holdings, Inc.
3. Aquestive Therapeutics, Inc. - Annual Reports. Annual Reports.
4. Assertio Holdings, Inc. Signs Exclusive License for Sympazan (clobazam) Oral Film from Aquestive Therapeutics, Inc.. GlobeNewswire.
5. Aquestive Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update. Aquestive Therapeutics.