RILUZOLE - Generic Drug Details

What are the generic drug sources for riluzole and what is the scope of freedom to operate?

Riluzole is the generic ingredient in four branded drugs marketed by Aquestive, Alkem Labs Ltd, Italfarmaco Sa, Covis, Apotex Corp, Daito Pharms Co Ltd, Glenmark Pharms Ltd, Impax Labs, Kenton, Pharmobedient, and Sun Pharm Inds Ltd, and is included in twelve NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Riluzole has twenty-five patent family members in twenty-one countries.

There are nine drug master file entries for riluzole. Six suppliers are listed for this compound.

Summary for RILUZOLE

International Patents:	25
US Patents:	1
Tradenames:	4
Applicants:	11
NDAs:	12
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	144
Patent Applications:	7,356
Drug Prices:	Drug price trends for RILUZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RILUZOLE
What excipients (inactive ingredients) are in RILUZOLE?	RILUZOLE excipients list
DailyMed Link:	RILUZOLE at DailyMed

See drug prices for RILUZOLE

Recent Clinical Trials for RILUZOLE

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

Sponsor	Phase
AB Science	PHASE3
PhenoNet, Inc.	PHASE2
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.	PHASE2

See all RILUZOLE clinical trials

Pharmacology for RILUZOLE

Drug Class

Benzothiazole

Medical Subject Heading (MeSH) Categories for RILUZOLE

Anticonvulsants

Excitatory Amino Acid Antagonists

Neuroprotective Agents

Anatomical Therapeutic Chemical (ATC) Classes for RILUZOLE

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for RILUZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIGLUTIK KIT	Oral Suspension	riluzole	50 mg/10 mL	209080	1	2021-03-12

US Patents and Regulatory Information for RILUZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Corp	RILUZOLE	riluzole	TABLET;ORAL	091300-001	Jun 18, 2013		DISCN	No	No
Alkem Labs Ltd	RILUZOLE	riluzole	SUSPENSION;ORAL	216035-001	Aug 22, 2024	AB	RX	No	No
Impax Labs	RILUZOLE	riluzole	TABLET;ORAL	076173-001	Jan 29, 2003	AB	RX	No	No
Italfarmaco Sa	TIGLUTIK KIT	riluzole	SUSPENSION;ORAL	209080-001	Sep 5, 2018	AB	RX	Yes	Yes			Y
Sun Pharm Inds Ltd	RILUZOLE	riluzole	TABLET;ORAL	091417-001	Jun 18, 2013		DISCN	No	No
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019		DISCN	Yes	No

Expired US Patents for RILUZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019
Covis	RILUTEK	riluzole	TABLET;ORAL	020599-001	Dec 12, 1995
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019

EU/EMA Drug Approvals for RILUZOLE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi Mature IP	Rilutek	riluzole	EMEA/H/C/000109Rilutek 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/002622Riluzole 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 RILUZOLE

Country	Patent Number	Title	Estimated Expiration
Portugal	2405890
Canada	2748856
World Intellectual Property Organization (WIPO)	2010102923
Denmark	2405890
San Marino	T201300022	Sospensioni liquide di riluzolo
Spain	2400349

Market Dynamics and Financial Trajectory for Riluzole

Last updated: July 27, 2025

Introduction

Riluzole remains a landmark in neurodegenerative disease therapeutics, primarily approved for the management of amyotrophic lateral sclerosis (ALS). Since its initial approval by the U.S. Food and Drug Administration (FDA) in 1995, riluzole's market presence has been shaped by evolving clinical insights, regulatory landscapes, and competitive pressures. This analysis explores the dynamic market environment for riluzole, projecting its financial trajectory and identifying key factors influencing its commercial prospects.

Market Overview and Clinical Indication

Riluzole is a neuroprotective agent that modulates glutamate activity, delaying disease progression in ALS patients. ALS is an incurable, rapidly progressive neurodegenerative disorder affecting motor neurons, with an estimated prevalence of 5 in 100,000 globally. Despite its limited efficacy—extending median survival by merely 2-3 months—riluzole has retained its position as a standard-of-care treatment, owing to its unique mechanism of action and regulatory approval status.

The current global ALS market was valued at approximately USD 130 million in 2022, with riluzole accounting for the majority share, especially in North America and Europe [1].

Market Dynamics

Regulatory Landscape and Patent Considerations

Initially developed by Sanofi, riluzole's patent has long expired, opening the door for generic formulations. This patent expiry has precipitated a decline in branded sales and increased price competition, thereby constraining revenue growth. However, regulatory data exclusivity in certain regions temporarily delayed generic entry, but most markets now feature multiple versions of riluzole at significantly reduced prices.

The absence of patent protection has incentivized off-label uses and formulation innovations, including sustained-release versions, which may extend the product lifecycle marginally. Regulatory agencies continue to scrutinize off-label prescribing, but genuine updates and indications could provide incremental revenue streams [2].

Market Penetration and Prescriber Preferences

Riluzole's prescribing remains entrenched due to clinical familiarity, albeit challenged by newer therapies under development. Clinicians weigh its modest survival benefit against cost and side-effect profiles. Increasing awareness about early diagnosis of ALS and supportive care strategies may sustain demand, especially in regions with established healthcare infrastructure. Conversely, in emerging markets, affordability and regulatory barriers limit its penetration.

Competitive Landscape

While riluzole monopolized ALS treatment for decades, recent entrants include other neuroprotective agents, combination therapies, and gene-based interventions, albeit none yet approved for widespread use. Experimental drugs targeting underlying disease mechanisms—such as Tofersen (sod1 antisense oligonucleotide)—are poised to supplement or replace riluzole as more efficacious options emerge. The introduction of such therapies could redefine market dynamics, exerting downward pressure on riluzole's revenue.

Pricing and Reimbursement

Post-patent expiry, pricing has plummeted. In the U.S., generic riluzole tablets are priced at approximately USD 0.50–1.00 per tablet, leading to low out-of-pocket costs for patients covered by insurance. Price sensitivity in developing countries and limited reimbursement frameworks restrain revenue growth globally. Coverage policies can significantly influence dispensed quantities, affecting overall sales.

R&D and Pipeline Developments

Research into new indications and delivery methods sustains some market interest. Trials focusing on neurodegenerative disorders beyond ALS—such as Parkinson’s disease—have been inconclusive or halted, limiting off-label expansion prospects. Nonetheless, pipeline drugs mimicking riluzole’s mechanism or enhancing its efficacy might influence future market dynamics.

Financial Trajectory Analysis

Historical Sales Performance

Following initial revenues of roughly USD 150 million in the late 1990s, sales peaked at approximately USD 180 million in 2005. Since then, sales have plateaued or declined marginally, predominantly due to generic competition. Recent estimates indicate global sales hovering around USD 80–90 million in 2022 [1].

Projected Revenue Trends

Forecasts suggest a continued decline in riluzole's revenues over the next five years, with compounded annual growth rates (CAGR) of approximately -4% to -6%. Such decline is attributed to:

• Market saturation.
• Off-label competition.
• Introduction of novel therapies.

However, revenue stabilization is possible if regulators approve new formulations, or if rare indications or combination therapies gain acceptance. The emergence of Alzheimer’s disease clinical trials and neurodegeneration studies presents an ancillary opportunity, albeit speculative at this stage [3].

Emerging Market Opportunities

Growing healthcare infrastructure and increasing neurologist awareness in Asia-Pacific and Latin America could expand riluzole’s usage, especially if prices remain low. Strategic partnerships and licensing agreements could bolster sales, particularly in regions where disease awareness campaigns are emerging.

Impact of Biosimilars and Generics

The proliferation of generic riluzole formulations has significantly diminished healthcare costs but challenged branded manufacturers’ profitability. Investments in pharmacovigilance, formulation improvements, and value-added indications are potential strategies to sustain revenues amidst generic competition.

Strategic Considerations for Stakeholders

• Pharmaceutical Developers: Focus on improving delivery mechanisms or developing combination products to differentiate from generics.
• Investors: Monitor regulatory approvals for new formulations, label expansions, or combination therapies that can extend market life.
• Healthcare Payers: Evaluate cost-effectiveness in light of limited clinical benefit; consider formulary restrictions to manage expenditures.
• Regulatory Bodies: Balance timely approval of innovative treatments against rigorous efficacy and safety assessments.

Key Market Challenges and Opportunities

Challenges	Opportunities
Patent expiration leading to generic competition	Development of new formulations or delivery systems
Modest clinical benefits limiting demand	Expansion into other neurodegenerative diseases
Competitive emergence of novel therapies	Strategic regional expansion in underserved markets
Limited reimbursement and affordability	Price reductions increasing access in emerging markets

Conclusion

The market for riluzole faces significant headwinds due to patent expiry, modest clinical benefits, and competitive innovation. Its financial trajectory is predominantly bearish in the near to medium term, with expected declines compounded by generics and evolving treatment paradigms. Nonetheless, strategic adaptation—through formulation advances, regional expansion, and exploring new indications—may mitigate revenue erosion and sustain its place within the neurodegenerative therapeutic landscape.

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Key Takeaways

• Market Saturation: Riluzole’s revenues are declining due to patent expiration and generic competition, with a forecasted CAGR of approximately -5% over the next five years.
• Clinical Limitations: The drug's limited efficacy constrains growth, emphasizing the need for innovative formulations or combination therapies.
• Emerging Opportunities: Opportunities exist in regional expansion and new indications, particularly in neurodegenerative diseases beyond ALS.
• Competitive Dynamics: The development of newer therapies and gene-based interventions could further displace riluzole’s market share.
• Strategic Focus: Stakeholders should prioritize formulations enhancement, geographic diversification, and pipeline development to prolong market relevance.

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FAQs

1. What are the primary drivers influencing riluzole’s market decline?
Patent expiry, availability of generic formulations, modest clinical efficacy, and competition from emerging therapies are principal factors.

2. Are there any new formulations or delivery methods for riluzole in development?
While some sustained-release and alternative delivery systems have been explored, no major new formulations have received recent regulatory approval. Ongoing research focuses on improving bioavailability and tolerability.

3. Can riluzole be used for conditions beyond ALS?
Current evidence limits riluzole’s approved use to ALS. Investigations into other neurodegenerative diseases show limited success; future approvals are unlikely without compelling clinical data.

4. How does pricing impact riluzole’s market dynamics?
Post-generic entry, prices have significantly decreased, limiting revenue potential but improving patient access. Price sensitivity varies regionally, influencing sales volumes.

5. Will the emergence of gene therapies replace riluzole entirely?
Gene therapies targeting underlying disease mechanisms are promising but remain in early stages. They could eventually displace riluzole if proven safe and effective, but currently serve as complementary or alternative options rather than outright replacements.

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References

[1] GlobalData. "ALS Market Analysis," 2022.
[2] FDA Regulatory Filings. "Riluzole Approvals and Patent Data," 2023.
[3] ClinicalTrials.gov. "Neurodegeneration Therapeutics Pipeline," 2023.