TIGLUTIK KIT Drug Patent Profile

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

Tiglutik Kit is a drug marketed by Italfarmaco Sa and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in twenty-one countries.

The generic ingredient in TIGLUTIK KIT 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 Tiglutik Kit

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

Summary for TIGLUTIK KIT

International Patents:	25
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	165
Patent Applications:	4,188
DailyMed Link:	TIGLUTIK KIT at DailyMed

Pharmacology for TIGLUTIK KIT

Drug Class

Benzothiazole

Paragraph IV (Patent) Challenges for TIGLUTIK KIT

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 TIGLUTIK KIT

TIGLUTIK KIT is protected by one US patents.

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			Y

EU/EMA Drug Approvals for TIGLUTIK KIT

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 TIGLUTIK KIT

See the table below for patents covering TIGLUTIK KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20130021
Hong Kong	1161985	RILUZOLE AQUEOUS SUSPENSIONS
Chile	2011002217	Suspension acuosa oral que comprende riluzol, un tensioactivo seleccionado de tensioactivos anionicos, tensioactivos no ionicos o una mezcla de ellos, y un agente de suspension seleccionado de arcillas esmectitas, celulosa microcristalina, gomas naturales o sus mezclas; y su uso para tratar esclerosis amiotrofica lateral.
Peru	20120649	SUSPENSIONES ACUOSAS DE RILUZOL

TIGLUTIK KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TIGLUTIK Kit

Introduction to TIGLUTIK Kit

TIGLUTIK is a formulation of riluzole, a drug used in the treatment of Amyotrophic Lateral Sclerosis (ALS). It was developed by ITF Pharma and approved by the FDA in 2018 as an oral suspension, addressing the needs of advanced-stage ALS patients who often suffer from dysphagia (difficulty swallowing)[1].

Market Positioning

Current Market Landscape

TIGLUTIK is part of a limited but growing market for ALS treatments. The global ALS market is expected to grow significantly, with projected sales reaching $1.04 billion by 2029 at a Compound Annual Growth Rate (CAGR) of 13.9%[1].

Competitors and Alternatives

TIGLUTIK competes with other formulations of riluzole, such as Sanofi's Rilutek and Aquestive Therapeutics' Exservan. However, its unique formulation as an oral suspension makes it particularly appealing for patients with swallowing difficulties. Additionally, it can be administered via percutaneous endoscopic gastrostomy (PEG) tubes, which is a significant advantage over traditional tablet forms[1].

Financial Performance

Initial Market Impact

Upon its approval in 2018, TIGLUTIK entered a market dominated by Rilutek and Radicava. The initial sales were part of the broader ALS market, which was approximately $282 million in 2019 across the 8 major markets (8MM), with the US being the largest market[1].

Revenue Contribution

While specific revenue figures for TIGLUTIK alone are not detailed, it is part of the overall riluzole market segment. The sales of riluzole-based drugs contribute significantly to the ALS market revenue. For instance, in 2019, the highest-selling drug in the ALS market was Mitsubishi's Radicava, but riluzole formulations, including TIGLUTIK, also played a crucial role[1].

Growth Prospects

Market Expansion

The ALS market is expected to grow substantially, driven by the launch of new therapies and the increasing demand for more effective treatments. TIGLUTIK, being a convenient and patient-friendly formulation, is likely to benefit from this growth. The forecast suggests that the ALS market will surpass $4 billion by 2034, with emerging therapies contributing significantly to this growth[2].

Pipeline and Future Developments

While TIGLUTIK itself is not a new drug but a reformulation, the overall ALS pipeline is rich with promising therapies. The success of these pipeline drugs will likely drive the market forward, and TIGLUTIK, as a part of the existing treatment landscape, will continue to play a role, especially for patients with specific needs such as dysphagia[2].

Challenges and Opportunities

Unmet Needs

Despite the availability of TIGLUTIK and other riluzole formulations, the ALS market still faces significant unmet needs. There is a lack of curative drugs and effective biomarkers, which presents opportunities for pharmaceutical companies to develop novel therapies. TIGLUTIK addresses some of these needs by providing a more manageable form of riluzole, but the market is ripe for more innovative solutions[1].

Regulatory and Market Dynamics

The ALS market is subject to regulatory scrutiny and market dynamics. For example, the decline in sales of RADICAVA due to its high cost and the introduction of generics in Japan highlights the challenges faced by ALS drugs. However, the approval of RADICAVA ORS, an oral suspension similar to TIGLUTIK, shows that reformulations can revitalize sales and patient adoption[2].

Key Takeaways

• Market Growth: The ALS market is expected to grow significantly, reaching $1.04 billion by 2029 and potentially surpassing $4 billion by 2034.
• Competitive Advantage: TIGLUTIK's unique formulation addresses the needs of advanced-stage ALS patients with dysphagia, providing a competitive edge.
• Revenue Contribution: While specific figures are not available, TIGLUTIK contributes to the overall revenue of riluzole-based treatments in the ALS market.
• Future Prospects: The drug will continue to play a role in the ALS treatment landscape, especially with the launch of new therapies and the growing demand for patient-friendly treatments.

FAQs

1. What is TIGLUTIK Kit used for? TIGLUTIK Kit is used for the treatment of Amyotrophic Lateral Sclerosis (ALS) and is specifically formulated as an oral suspension to help patients with difficulty swallowing.

2. How does TIGLUTIK Kit differ from other riluzole formulations? TIGLUTIK Kit is the first liquid formulation of riluzole and can be administered via PEG tubes, making it more accessible for patients with advanced-stage ALS and dysphagia.

3. What is the current market size for ALS treatments? The current market size for ALS treatments in the US was estimated to be around $920 million in 2023 and is expected to grow during the forecast period (2024–2034)[5].

4. What are the growth prospects for the ALS market? The ALS market is expected to grow significantly, reaching $1.04 billion by 2029 and potentially surpassing $4 billion by 2034, driven by new therapies and increasing demand[1][2].

5. What are the main challenges in the ALS treatment market? The main challenges include the lack of curative drugs, effective biomarkers, and the high failure rate in clinical trials due to the unclear etiology and complex pathophysiology of ALS[1][2].

Sources

1. ResearchAndMarkets.com - "Amyotrophic Lateral Sclerosis (ALS) - Opportunity Analysis and Forecasts to 2029"
2. DelveInsight - "Evolving Treatment Landscape of Amyotrophic Lateral Sclerosis"
3. Annual Reports - United States Securities and Exchange Commission
4. DelveInsight - "Amyotrophic Lateral Sclerosis Market Size"
5. DelveInsight - "Amyotrophic lateral sclerosis (ALS) Market Size, Share"