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. Seven 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:	166
Clinical Trials:	31
Patent Applications:	4,237
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
Ning Jin	Phase 1
Corestem, Inc.	Phase 3
Cross Research S.A.	Phase 1

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/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 RILUTEK

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

Country	Patent Number	Title	Estimated Expiration
France	2688138	APPLICATION DE L'AMINO-2 TRIFLUOROMETHOXY-6 BENZOTHIAZOLE POUR OBTENIR UN MEDICAMENT DESTINE AU TRAITEMENT DE LA SCLEROSE LATERALE AMYOTROPHIQUE.
Spain	2098558
Canada	2117466	APPLICATION DE L'AMINO-2 TRIFLUOROMETHOXY-6 BENZOTHIAZOLE POUR OBTENIR UN MEDICAMENT DESTINE AU TRAITEMENT DES MALADIES DU MOTONEURONE (APPLICATION OF 2-AMINO 6-TRIFLUOROMETHOXY BENZOTHIAZOLE FOR OBTAINING A DRUG USEFUL IN THE TREATMENT OF MOTOR NEURON DISEASES)

RILUTEK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rilutek

Introduction to Rilutek

Rilutek, also known as riluzole, is a medication primarily used for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neurological disease. Here, we will delve into the market dynamics and financial trajectory of Rilutek, highlighting its current status, future projections, and key factors influencing its market.

Current Market Size and Forecast

As of 2023, the global Rilutek market was valued at US$ 40 million. However, it is anticipated to decline slightly to US$ 38 million by 2030, with a Compound Annual Growth Rate (CAGR) of -1.2% during the forecast period of 2024-2030[1].

Market Share and Dominance

Riluzole remains a dominant player in the ALS treatment market. In 2022, the riluzole segment held a significant market share of 37% and is expected to maintain its dominance throughout the forecast period due to its widespread adoption and availability from various key players[3][4].

Competitive Landscape

The Rilutek market is characterized by a competitive landscape with several key players, including Sanofi, Mylan Pharma, Apotex, Glemark Generics, Covis Pharma, Sun Pharma, Lunan Pharma, and Italfarmaco. These companies contribute to the market's dynamics through their production and distribution of Rilutek[1].

Cost-Effectiveness and Economic Evaluation

A cost-utility analysis of Rilutek has shown that while it extends life, it comes with significant costs. The acquisition cost and bi-monthly monitoring for raised ALT levels are key cost components. The study estimated the cost per life year gained to be around £14,370 and the cost per Quality Adjusted Life Year (QALY) to be around £20,904, highlighting the economic implications of using Rilutek[2].

Regional Market Dynamics

The ALS treatment market, including Rilutek, is geographically diverse. North America dominated the market in 2022 with the highest revenue share, primarily due to genetic predisposition, environmental factors, and a strong focus on research and development. However, the Asia-Pacific region is expected to grow at the highest rate during the forecast period, driven by the presence of pharmaceutical companies and increasing healthcare expenditure in countries like China and India[3][4].

Treatment Segments and End-User Insights

The ALS treatment market is segmented into various types, including medication, respiratory therapy, speech therapy, physical therapy, chemotherapy, and stem cell therapy. Medication, which includes Rilutek, holds the highest revenue share of 22% and is projected to grow at a CAGR of 5.59% during the forecast period. Hospitals dominate the end-user segment, indicating a significant portion of Rilutek sales occur through hospital channels[3][4].

Pipeline and Future Developments

While Rilutek and Edaravone currently dominate the ALS treatment market, there are several pipeline drugs expected to launch over the forecast period. These new therapies aim to address unmet clinical needs and are anticipated to be used as adjunctive therapies to existing treatments like Rilutek. This could potentially impact the market share of Rilutek but also indicates a growing market for ALS treatments overall[5].

Financial Projections and Growth Drivers

Despite the slight decline in the Rilutek market size, the broader ALS treatment market is expected to grow significantly. The global ALS treatment market is projected to reach US$ 1.04 billion by 2029, with a CAGR of 13.9%. This growth is driven by increased awareness of ALS, rising healthcare expenditure, and the launch of new pipeline drugs[5].

Challenges and Limitations

The market growth for Rilutek and other ALS treatments is hampered by side effects associated with the drugs. Additionally, the high cost of these medications and the limited efficacy in significantly slowing the progression of ALS pose challenges to market expansion[4].

Key Takeaways

• Market Size: The global Rilutek market is valued at US$ 40 million in 2023 and is expected to decline to US$ 38 million by 2030.
• Market Share: Riluzole dominates the ALS treatment market with a 37% market share in 2022.
• Cost-Effectiveness: Rilutek's cost per QALY is estimated to be around £20,904.
• Regional Growth: North America currently leads, but the Asia-Pacific region is expected to grow at the highest rate.
• Treatment Segments: Medication, including Rilutek, holds the highest revenue share.
• Future Developments: Pipeline drugs are expected to impact the market, but overall ALS treatment market growth is robust.

FAQs

What is the current market size of Rilutek?

The global Rilutek market was valued at US$ 40 million in 2023[1].

Who are the main players in the Rilutek market?

The main players include Sanofi, Mylan Pharma, Apotex, Glemark Generics, Covis Pharma, Sun Pharma, Lunan Pharma, and Italfarmaco[1].

What is the forecasted growth rate of the Rilutek market?

The Rilutek market is expected to decline at a CAGR of -1.2% from 2024 to 2030[1].

How does Rilutek compare to other ALS treatments in terms of market share?

Riluzole holds a significant market share of 37% in the ALS treatment market as of 2022[3].

What are the key cost components associated with Rilutek?

The key cost components include the acquisition cost and bi-monthly monitoring for raised ALT levels[2].

What is the projected size of the broader ALS treatment market by 2029?

The global ALS treatment market is expected to reach US$ 1.04 billion by 2029[5].

Sources

1. Global Rilutek Market Research Report 2024 - Valuates Reports
2. Cost utility analysis of riluzole for the treatment of amyotrophic lateral sclerosis - PubMed
3. Amyotrophic Lateral Sclerosis Treatment Market Sales to Reach US$ 1021 Million in 2032 - GlobeNewswire
4. Amyotrophic Lateral Sclerosis Treatment Market Forecast - 2032 - Allied Market Research
5. Amyotrophic Lateral Sclerosis (ALS) Markets - $1.04 Billion Opportunity Analysis and Forecasts to 2029 - Business Wire