EXSERVAN Drug Patent Profile

Which patents cover Exservan, and what generic alternatives are available?

Exservan is a drug marketed by Aquestive and is included in one NDA.

The generic ingredient in EXSERVAN is riluzole. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the riluzole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Exservan

A generic version of EXSERVAN was approved as riluzole by IMPAX LABS on January 29^th, 2003.

Summary for EXSERVAN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	166
Patent Applications:	4,232
Drug Prices:	Drug price information for EXSERVAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXSERVAN
What excipients (inactive ingredients) are in EXSERVAN?	EXSERVAN excipients list
DailyMed Link:	EXSERVAN at DailyMed

See drug prices for EXSERVAN

US Patents and Regulatory Information for EXSERVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019		DISCN	Yes	No

Expired US Patents for EXSERVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019	8,603,514
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019	8,765,167

EU/EMA Drug Approvals for EXSERVAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi Mature IP	Rilutek	riluzole	EMEA/H/C/000109 Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).Clinical trials have demonstrated that Rilutek extends survival for patients with ALS.Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.Rilutek has not been shown to be effective in the late stages of ALS.Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor-neurone disease.	Authorised	no	no	no	1996-06-10
Zentiva k.s.	Riluzole Zentiva	riluzole	EMEA/H/C/002622 Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS.Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease.	Authorised	no	no	no	2012-05-07

International Patents for EXSERVAN

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

Country	Patent Number	Title	Estimated Expiration
Australia	2014227693	Sublingual and buccal film compositions
Australia	2017200626	SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
Australia	2002332118
European Patent Office	2568975	COMPOSITIONS EN FILM POUR LA DISTRIBUTION D'AGENTS ACTIFS (FILM COMPOSITIONS FOR DELIVERY OF ACTIVES)
Japan	2009518405
Japan	6035369
World Intellectual Property Organization (WIPO)	2011143424

Market Dynamics and Financial Trajectory for Exservan

Introduction to Exservan

Exservan is an oral film formulation of the drug riluzole, which was originally approved by the FDA in 1995 under the brand name Rilutek for the treatment of amyotrophic lateral sclerosis (ALS). The oral film version of riluzole, Exservan, was approved in 2019, offering a more convenient and easier-to-administer alternative for ALS patients who struggle with swallowing tablets or using oral suspensions[4].

Market Segmentation and Competition

The ALS therapeutics market is segmented based on drug type, with Exservan falling under the category of riluzole formulations. This market segment competes with other ALS treatments such as edaravone (Radicava), tofersen, and riluzole in other forms like Tiglutik (oral suspension)[1].

Route of Administration and Patient Preference

Exservan's oral film formulation is a significant advantage, as it can be easily administered by dissolving under the tongue, making it more accessible for ALS patients with swallowing difficulties. This convenience is expected to drive patient preference and adherence to treatment[4].

Pricing and Cost Considerations

The cost of Exservan is a critical factor in its market dynamics. Initially, the pricing was expected to be in line with Tiglutik, another oral formulation of riluzole, which costs around $25,000 annually. However, the actual cost of Exservan for a supply of 60 films is approximately $3,291, which is competitive with its primary competitor, Tiglutik[4].

Distribution Strategy

Mitsubishi Tanabe Pharma America has adopted an exclusive distribution strategy for Exservan, partnering with PANTHERx Rare as the specialty pharmacy provider. This limited distribution approach is aimed at ensuring controlled and efficient access to the medication for ALS patients[4].

Market Growth and Forecast

The global ALS therapeutics market, which includes Exservan, is projected to grow significantly. The market size is expected to increase from $0.77 billion in 2024 to $1.80 billion by 2032, with a CAGR of 11.3% during the forecast period. The oral segment, which includes Exservan, dominated the market in 2023 and is expected to continue growing due to the increasing number of oral pipeline drugs[1].

Regional Market Performance

The market growth for ALS therapeutics, including Exservan, varies by region. Europe accounted for a substantial market share in 2023, driven by the commercialization of drugs like Radicava and the expected approval of pipeline drugs. The Asia Pacific region is anticipated to grow at the fastest CAGR during the forecast period due to increasing awareness and market player focus on clinical trials in the region[1].

Financial Performance and Revenue Projections

While specific financial data for Exservan alone is not readily available, the overall ALS therapeutics market provides a context for its financial trajectory. The market's growth is driven by the increasing prevalence of ALS and the approval of new drugs. The edaravone segment, which is a key competitor, is expected to dominate the market, but the oral segment, where Exservan belongs, is also anticipated to grow significantly due to the convenience and accessibility of oral formulations[1].

Impact of Regulatory Approvals and Clinical Trials

Regulatory approvals play a crucial role in the financial trajectory of Exservan. The FDA approval in 2019 was a significant milestone, and any future approvals or updates in clinical trials for ALS treatments can impact the market dynamics and revenue projections for Exservan. The withdrawal of other drugs, such as Relyvrio, due to clinical trial failures, also affects the competitive landscape and can benefit Exservan if it maintains its safety and efficacy profile[1].

Market Players and Competitive Landscape

Major players in the ALS therapeutics market include Biogen, Mitsubishi Tanabe Pharma, and Sanofi. These companies focus on commercializing their products globally and investing in research and development to enhance their product portfolios. Mitsubishi Tanabe Pharma's strategic distribution deal for Exservan highlights their commitment to making this drug accessible to ALS patients[1].

Challenges and Opportunities

Despite the advantages of Exservan's oral film formulation, there are challenges such as competition from other ALS treatments and the high cost of these medications. However, the increasing awareness about ALS and the growing focus on rare diseases present opportunities for market growth. The failure of other drugs in late-stage clinical trials can also create a window of opportunity for Exservan to capture a larger market share[1][4].

Key Takeaways

• Market Growth: The ALS therapeutics market is expected to grow significantly, driven by the increasing prevalence of ALS and the approval of new drugs.
• Oral Segment Dominance: The oral segment, which includes Exservan, dominated the market in 2023 and is expected to continue growing.
• Pricing and Distribution: Exservan's pricing is competitive, and its exclusive distribution strategy aims to ensure controlled access.
• Regulatory Impact: FDA approvals and clinical trial outcomes are crucial for the financial trajectory of Exservan.
• Competitive Landscape: Major players like Mitsubishi Tanabe Pharma are focusing on commercialization and R&D to enhance their product portfolios.

FAQs

1. What is Exservan, and how is it different from other ALS treatments? Exservan is an oral film formulation of riluzole, making it easier to administer for ALS patients who struggle with swallowing tablets or using oral suspensions.

2. How much does Exservan cost, and how does it compare to other ALS treatments? Exservan costs approximately $3,291 for a supply of 60 films, which is competitive with other oral formulations like Tiglutik.

3. Who is the primary distributor of Exservan, and what is their distribution strategy? Mitsubishi Tanabe Pharma America has partnered with PANTHERx Rare as the exclusive specialty pharmacy provider for Exservan, adopting a limited distribution approach.

4. What is the projected market growth for ALS therapeutics, and how does Exservan fit into this growth? The ALS therapeutics market is expected to grow from $0.77 billion in 2024 to $1.80 billion by 2032, with the oral segment, including Exservan, expected to contribute significantly to this growth.

5. How do regulatory approvals and clinical trials impact the financial trajectory of Exservan? Regulatory approvals and clinical trial outcomes are critical for the financial trajectory of Exservan, as they influence market dynamics, competition, and revenue projections.

Cited Sources:

1. Fortune Business Insights: Amyotrophic Lateral Sclerosis Therapeutics Market Size [2032]
2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results
3. Annual Reports: United States Securities and Exchange Commission - Annual Reports
4. Anton Health: Exclusive Distribution Deal for FDA Rx Approved in 2019