RILUTEK Drug Patent Profile

Which patents cover Rilutek, and when can generic versions of Rilutek launch?

Rilutek is a drug marketed by Covis and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rilutek

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

Summary for RILUTEK

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	33
Patent Applications:	4,520
Drug Prices:	Drug price information for RILUTEK
What excipients (inactive ingredients) are in RILUTEK?	RILUTEK excipients list
DailyMed Link:	RILUTEK at DailyMed

See drug prices for RILUTEK

Recent Clinical Trials for RILUTEK

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

Sponsor	Phase
Beijing Tiantan Hospital	PHASE1
Neurodawn Pharmaceutical Co., Ltd.	PHASE1
Oliver Blanchard	PHASE2

See all RILUTEK clinical trials

US Patents and Regulatory Information for RILUTEK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	RILUTEK	riluzole	TABLET;ORAL	020599-001	Dec 12, 1995		DISCN	Yes	No

Expired US Patents for RILUTEK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	RILUTEK	riluzole	TABLET;ORAL	020599-001	Dec 12, 1995	5,527,814

EU/EMA Drug Approvals for RILUTEK

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 RILUTEK

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	281293	Použití 2-amino-6-trifluormethoxybenzothiazolu pro získání léčiva určeného pro léčení nemocí hybného neuronu (THE USE OF 2-AMINO-6-TRIFLUOROMETHOXYBENZOTHIAZOLE FOR OBTAINING A MEDICAMENT DETERMINED FOR TREATING DISEASES OF MOTOR NEURON)
Japan	2713384
World Intellectual Property Organization (WIPO)	9317683

Market Dynamics and Financial Trajectory for Rilutek (Riluzole)

Last updated: August 1, 2025

Introduction

Rilutek, branded as Riluzole, is a pharmaceutical medication primarily approved for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Since its initial US approval in 1995, Riluzole has experienced a complex market evolution shaped by scientific advances, competitive dynamics, regulatory shifts, and evolving treatment paradigms. This analysis assesses the current market landscape and projects the financial trajectory for Rilutek within it.

Pharmacological Profile and Therapeutic Value

Riluzole functions as a neuroprotective agent, modulating glutamatergic neurotransmission to slow neuronal degeneration associated with ALS. Although Riluzole does not halt disease progression, it extends survival by approximately 2-3 months and delays time to tracheostomy or permanent ventilation [1]. Its mechanism lends itself to a niche yet critical role in neurodegenerative disease management, underpinning its sustained relevance.

Market Dynamics

1. Disease Epidemiology and Patient Population

ALS affects approximately 2-3 per 100,000 individuals worldwide, with about 20,000-30,000 cases in the United States [2]. The disease predominantly manifests in adults aged 40-70, with a slight male predilection. The relatively small patient population constrains the overall market size; however, high unmet needs sustain demand.

2. Competitive Landscape

While RiluteK remains the cornerstone therapy, emerging treatments and pipeline candidates challenge its dominance:

• Edaravone (Radicava): Approved by FDA in 2017, it offers an alternative neuroprotective approach, mildly extending survival and functional scales. Its annual sales in ALS indications have reached approximately $300 million globally [3].

• Other pipeline agents: Several antisense therapies and gene-editing strategies are progressing through clinical development, aiming for longer-term effects or disease-modifying capabilities.

The introduction of these alternatives threatens RiluteK's market share gradually. Nonetheless, as of 2023, RiluteK maintains a significant position due to its early approval and established clinical adoption.

3. Pricing, Reimbursement, and Market Access

Rilutin's pricing varies globally, often ranging between $1,000 to $3,000 per month, contingent on healthcare system reimbursement policies. In the U.S., Medicare and insurance coverage sustain stable revenue streams. However, rising concerns over drug affordability and policy reforms for high-cost therapies could influence future pricing strategies and reimbursement levels.

4. Regulatory and Patent Landscape

Riluzole's patent protections have long expired, enabling generic competition in multiple jurisdictions. Generic versions have significantly reduced the drug’s price, intensifying market competition and pressuring brand sales.

Regulatory challenges include approval of biosimilars or competing molecules, which could erode premiums and threaten exclusivity. Nonetheless, adherence to clinical guidelines and the lack of long-term alternatives strengthen Rilutex's positioning.

5. Clinical and Safety Considerations

The safety profile of Riluzole is well-characterized, with potential adverse effects including elevated liver enzymes and fatigue. Its safety advantage over emerging therapies may sustain its use, especially among specific patient subgroups contraindicated for newer agents.

Financial Trajectory Analysis

1. Revenue Trends

Historically, Rilutek generated peak annual revenues of approximately $200-300 million globally, driven predominantly by the U.S. and European markets [4]. Following patent expirations and increased generic competition, global revenues declined sharply beginning around 2010.

In the current landscape, annual sales are estimated to be in the $50-70 million range, primarily driven by existing prescriptions, with limited growth prospects.

2. Impact of Generic Competition

The entry of generics has compressed margins, with prices falling by over 80% in some markets. This scenario limits the revenue potential for branded formulations but ensures broader medicine access, which could moderate decline rates.

3. Market Expansion Opportunities

Limited due to the small patient population. However, off-label use in other neurodegenerative diseases or combination therapies could create marginal growth avenues. Clinical trials exploring Rilustat in other indications (e.g., depression, schizophrenia) could open off-label or new markets, though evidence remains preliminary.

4. Growth Drivers and Risks

• Growth Drivers: Increasing awareness of ALS among clinicians, improvements in diagnostics, and potential inclusion in combination treatments.

• Risks: Intense generic competition, reimbursement constraints, regulatory hurdles for new indications, and emerging therapies offering superior efficacy.

Forecast Summary

Given the current market conditions, the financial outlook for Rilutek suggests continued revenue stability over the next 3-5 years, with gradual decline attributable to generic erosion. Any significant upward trajectory relies on potential future approvals of novel formulations, expanded indications, or label improvements, none of which are imminent.

Regulatory and Market Strategy Considerations

Pharmaceutical companies holding Riluzione's rights should consider:

• Cost-effective pricing strategies in mature markets to retain volume.

• Investments in lifecycle management, potentially developing new formulations or combination therapies.

• Collaborations with research institutions to explore novel indications, which could rejuvenate demand.

Conclusion

Rilutek’s market dynamics are emblematic of mature, small-population drugs in the neurodegenerative space, facing declining revenues due to generic competition yet maintaining a firm niche due to clinical efficacy and safety. The financial trajectory suggests a plateauing or modest decline, contingent upon ongoing patent challenges and competitive innovations.

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Key Takeaways

• Rilutek’s initial blockbuster status has waned with patent expiries, but it remains clinically relevant for ALS management.

• The small patient population limits growth prospects, though demand remains stable for now due to unmet needs.

• Generic competition has significantly lowered prices, constraining revenue and margins.

• Future growth hinges on demonstrating added value, expanding indications, or developing combination therapies.

• Companies should strategize around lifecycle management and cost optimization to sustain profitability.

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FAQs

1. What is the current global market size for Rilutek?
The global market size for Rilutek is estimated at approximately $50-70 million annually, primarily driven by established markets like the U.S. and Europe, with ongoing declines due to generic competition.

2. How does the emergence of new ALS therapies impact Rilutek’s market share?
New therapies, especially those with longer survival benefits or disease-modifying effects, threaten Rilutek’s dominance. However, Rilutek’s well-established safety profile and clinician familiarity help sustain its use.

3. Are there any approved pipeline drugs that could replace Rilutek?
While several pipeline agents, including antisense therapies and neuroprotective compounds, are in development, none have yet supplanted Rilutex’s market position comprehensively.

4. How do pricing strategies affect Rilutex’s profitability amid generic competition?
Price reductions driven by generic entry have compressed margins. Focused pricing strategies, patient access programs, and lifecycle approaches are crucial for maintaining profitability.

5. Could Rilutek’s market expand into other neurological diseases?
Currently, no significant regulatory approvals support broader indications. Off-label use remains limited; future research could unlock new opportunities but remains uncertain.

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References

[1] Miller, R. G., et al. (2007). "Riluzole for ALS: an overview." Alzheimer’s & Dementia.
[2] Chiò, A., et al. (2013). "Epidemiology of ALS." Progress in Brain Research.
[3] (Global Sales Data for Radicava). EvaluatePharma Reports.
[4] Drug Sales Reports, IMS Health.

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Note: All financial figures and data are approximate estimates based on industry reports and available market analyses as of 2023.