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, Mylan Pharms Inc, and Sun Pharm Inds Ltd, and is included in twelve NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Riluzole has one hundred and eighty-seven patent family members in twenty-nine countries.

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

Summary for RILUZOLE

International Patents:	187
US Patents:	3
Tradenames:	4
Applicants:	11
NDAs:	12
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	130
Patent Applications:	6,721
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
University of Sydney	Phase 2/Phase 3
FightMND	Phase 2/Phase 3
Mario Negri Institute for Pharmacological Research	Phase 2/Phase 3

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
Italfarmaco Sa	TIGLUTIK KIT	riluzole	SUSPENSION;ORAL	209080-001	Sep 5, 2018	AB	RX	Yes	Yes	8,765,150		Y
Sun Pharm Inds Ltd	RILUZOLE	riluzole	TABLET;ORAL	091417-001	Jun 18, 2013		DISCN	No	No
Covis	RILUTEK	riluzole	TABLET;ORAL	020599-001	Dec 12, 1995		DISCN	Yes	No

Expired US Patents for RILUZOLE

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
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 RILUZOLE

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 RILUZOLE

Country	Patent Number	Title	Estimated Expiration
Croatia	P20130021
Russian Federation	2015143647	ПЛЕНОЧНЫЕ КОМПОЗИЦИИ ДЛЯ СУБЛИНГВАЛЬНОГО И БУККАЛЬНОГО ВВЕДЕНИЯ
Australia	2006329819	pH modulated films for delivery of actives

RILUZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Riluzole

Introduction

Riluzole, a small molecule drug developed by Sanofi, is primarily used in the treatment of Amyotrophic Lateral Sclerosis (ALS), a neurodegenerative disease affecting nerve cells in the brain and spinal cord. Here, we delve into the market dynamics and financial trajectory of Riluzole, exploring its current market status, future projections, and the factors influencing its economic viability.

Market Size and Forecast

The global Riluzole Tablet market was valued at US$ 40 million in 2023 and is anticipated to reach US$ 38 million by 2030, experiencing a Compound Annual Growth Rate (CAGR) of -1.2% during the forecast period of 2024-2030[1].

Key Players

The Riluzole market is dominated by several key players, including Sanofi, Mylan Pharma, Apotex, Glemark Generics, Covis Pharma, Sun Pharma, Lunan Pharma, and Italfarmaco. These companies play a crucial role in the production, distribution, and marketing of Riluzole tablets[1].

Applications and Types

Riluzole is primarily used in hospitals and pharmacies. The drug is available in two main types: film-coated and non-film-coated tablets. These variations cater to different patient needs and preferences[1].

Therapeutic Areas

Riluzole falls under the therapeutic areas of Nervous System Diseases, Endocrinology, and Metabolic Disease. Its approval in 1995 marked a significant milestone in ALS treatment, providing patients with a viable option to manage their condition[3].

Cost-Benefit Analysis

A cost-benefit analysis of Riluzole therapy reveals that while the drug increases patient survival by approximately 3 months, it also imposes additional costs on health services. The cost per patient for Riluzole is around $US2247, resulting in an extra burden of $US757 on health services. However, the overall resource benefits to society, including increased productivity and the valuation of extra months of life, outweigh the costs, with a benefit:cost ratio of 2.89:1[2].

Market Drivers

The demand for Riluzole is driven by several factors:

• Increasing Adoption: The riluzole segment dominates the global ALS treatment market, and this trend is expected to continue due to the increased adoption of Riluzole for ALS treatment[4].
• Healthcare Expenditure: Improved healthcare expenditure in emerging markets and the rise in unmet healthcare needs contribute to the growth of the ALS treatment market, including Riluzole[4].
• Awareness and Early Diagnosis: Increased awareness among patients about the importance of early diagnosis and treatment of ALS drives the demand for ALS drugs like Riluzole[4].

Market Challenges

Despite its dominance, the Riluzole market faces several challenges:

• Negative Growth Rate: The global Riluzole Tablet market is expected to decline at a CAGR of -1.2% from 2024 to 2030, indicating a potential slowdown in market growth[1].
• Competition from New Treatments: The approval of new ALS treatments, such as RELYVRIO (sodium phenylbutyrate and taurursodiol), could potentially compete with Riluzole and impact its market share[4].

Adherence and Patient Outcomes

Studies on adherence to Riluzole therapy, such as the CAESAR study, indicate that most ALS patients adhere to the therapy during the first year. However, patients who discontinue therapy early show greater fragility and higher mortality rates. This highlights the importance of patient adherence for optimal outcomes[5].

Distribution Channels

The distribution of Riluzole is primarily through hospitals and pharmacies. The market is bifurcated into sporadic ALS and familial ALS segments, with sporadic ALS dominating due to higher incidence rates[4].

Financial Implications

The financial trajectory of Riluzole is influenced by its cost, benefits, and market dynamics. While the drug imposes additional costs on health services, the overall societal benefits, including increased productivity and extended life expectancy, justify its use. The cost per life-year gained is approximately $US12,013, but the total benefits to society, including productivity and the valuation of extra life months, amount to $US6483, making it a cost-effective treatment from a societal perspective[2].

Conclusion

Riluzole remains a crucial drug in the treatment of ALS, despite the anticipated decline in its market size. Its dominance in the ALS treatment market is driven by its effectiveness and the lack of alternative treatments. However, the emergence of new treatments and the need for continuous patient adherence are key factors that will shape its future market dynamics.

Key Takeaways

• Market Size: The global Riluzole Tablet market is expected to decline from US$ 40 million in 2023 to US$ 38 million by 2030.
• Key Players: Sanofi, Mylan Pharma, Apotex, and others dominate the market.
• Therapeutic Areas: Riluzole is used in Nervous System Diseases, Endocrinology, and Metabolic Disease.
• Cost-Benefit Analysis: The drug offers significant societal benefits despite additional health service costs.
• Market Drivers: Increased adoption, healthcare expenditure, and awareness drive demand.
• Challenges: Negative growth rate and competition from new treatments are potential challenges.

FAQs

Q: What is the current market size of the Riluzole Tablet market? A: The global Riluzole Tablet market was valued at US$ 40 million in 2023[1].

Q: Who are the main players in the Riluzole market? A: The main players include Sanofi, Mylan Pharma, Apotex, Glemark Generics, Covis Pharma, Sun Pharma, Lunan Pharma, and Italfarmaco[1].

Q: What are the primary therapeutic areas for Riluzole? A: Riluzole is used in the therapeutic areas of Nervous System Diseases, Endocrinology, and Metabolic Disease[3].

Q: How does Riluzole impact patient survival? A: Riluzole increases patient survival by approximately 3 months and delays the need for mechanical ventilation[2][5].

Q: What are the key drivers of the Riluzole market? A: The market is driven by increased adoption, improved healthcare expenditure, and increased awareness about early diagnosis and treatment of ALS[4].

Sources

1. Global Riluzole Tablet Market Research Report 2024 - Valuates Reports
2. Cost-benefit analysis of riluzole for the treatment of amyotrophic lateral sclerosis - PubMed
3. Decoding Riluzole: A Comprehensive Study of its R&D Trends and Market - Synapse Patsnap
4. Amyotrophic Lateral Sclerosis Treatment Market Forecast - 2032 - Allied Market Research
5. Adherence to riluzole therapy in patients with amyotrophic lateral sclerosis in three Italian regions—The CAESAR study - Wiley Online Library