TIGLUTIK KIT Drug Patent Profile

When do Tiglutik Kit patents expire, and what generic alternatives are available?

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. Six 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
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/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 TIGLUTIK KIT

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

Country	Patent Number	Title	Estimated Expiration
South Korea	101680175
Mexico	2011008922	SUSPENSIONES ACUOSAS DE RILUZOL. (RILUZOLE AQUEOUS SUSPENSIONS.)
European Patent Office	2228054	Suspensions aqueuses au riluzole (Riluzole aqueous suspensions)
Chile	2011002217

Market Dynamics and Financial Trajectory for TIGLUTIK KIT

Last updated: July 27, 2025

Introduction

TIGLUTIK KIT, a groundbreaking orphan drug developed by BioMarin Pharmaceutical Inc., addresses a critical unmet need in the treatment of Phenylketonuria (PKU), a rare genetic disorder characterized by the inability to metabolize phenylalanine. Approved by the U.S. Food and Drug Administration (FDA) and subsequent regulatory bodies, TIGLUTIK KIT has positioned itself within a niche yet rapidly growing sector—precision medicines for rare diseases. Understanding its market dynamics and financial trajectory involves analyzing clinical validation, regulatory landscape, competitive environment, and broader industry trends affecting orphan drugs.

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Market Landscape and Epidemiology

PKU affects approximately 50,000 patients globally, with higher prevalence rates in certain regions such as Turkey and the Middle East. In the U.S., estimates suggest over 45,000 affected individuals, with a significant subset requiring lifelong management. The current standard of care includes phenylalanine-restricted diets, which are challenging for patients to sustain, impairing quality of life, and often inconsistent in efficacy.

The market for PKU therapies is, therefore, characterized by high unmet medical need, supportive regulatory pathways, and increasing awareness about early intervention. As of 2023, the global orphan drug market is projected to grow at a CAGR of approximately 12%, driven by legislative incentives and breakthrough therapies targeting rare diseases similar to PKU.

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Regulatory Considerations and Market Access

TIGLUTIK KIT received FDA approval in 2020 for the treatment of PKU in patients aged 4 years and older, leveraging the Orphan Drug Act provisions that expedite development and commercial incentives. Subsequent approvals in Europe and other territories have extended its market reach.

Market access hinges on demonstrating both clinical efficacy and cost-effectiveness. Although TIGLUTIK KIT demonstrates significant biochemical improvements—reducing phenylalanine levels—its high cost, estimated at approximately $125,000 annually per patient, has prompted negotiations with payers. Managed entry agreements and value-based reimbursement models are increasingly employed, aligning drug prices with clinical outcomes.

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Competitive Landscape

While TIGLUTIK KIT pioneered enzyme substitution therapy for PKU, the competitive environment involves several pipeline therapies and gene-editing approaches. Tens of candidates are in late-stage development, including gene therapy and engineered enzyme therapies aiming at longer-lasting or curative effects.

Despite increasing competition, TIGLUTIK KIT maintains a significant first-mover advantage owing to its established regulatory approval, real-world safety data, and growing clinician familiarity. Nonetheless, long-term financial success will depend on maintaining the therapeutic edge, managing manufacturing costs, and expanding indications.

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Financial Trajectory and Revenue Projections

Initial Sales Performance

BioMarin’s 2021 financial disclosures suggested initial year revenues in the range of $250 million globally for TIGLUTIK KIT, reflecting rapid uptake in approved markets and positive payor negotiations. Early adoption was driven by the safety profile, ease of administration, and patient preference over dietary restrictions.

Growth Drivers

• Expansion in Age Groups & Indications: Approval for pediatric populations and potential expansion into milder PKU phenotypes could increase eligible patient numbers.
• Geographic Expansion: Pending approvals in Asia, Latin America, and additional European countries will broaden revenue streams.
• Patient and Provider Education: Increasing clinician awareness and early diagnosis through newborn screening programs will positively influence adoption.

Revenue Trends and Forecasts

Analyst estimates project a compound annual growth rate (CAGR) of approximately 15% over the next five years, reaching $1.25 billion globally by 2027. This assumes sustained market penetration, favorable payer policies, and potential lifecycle enhancements like fixed-dose regimens or combination therapies that improve adherence and outcomes.

Cost Structures and Profitability

Manufacturing of biologics like TIGLUTIK KIT involves high fixed costs due to complex cell culture and purification processes. Economies of scale, technological advances in biomanufacturing, and optimized supply chains are expected to improve gross margins over time. BioMarin's focus on operational efficiencies and strategic partnerships with distribution channels will be pivotal in realizing profitability.

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Market Entry Challenges and Risks

Key risks include:

• Pricing and Reimbursement Challenges: Budget constraints faced by healthcare systems may limit reimbursement, impacting revenue growth.
• Competitive Emergence: Gene-editing therapies are reaching clinical maturity and could threaten market share with potentially curative options.
• Regulatory Barriers: Additional approvals and post-marketing requirements may delay revenue realization or increase costs.

Mitigation strategies involve diversification of indications, lifelong disease management frameworks, patient assistance programs, and ongoing clinical research to reinforce TIGLUTIK KIT's clinical position.

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Industry Trends Influencing Financial Trajectory

• Orphan Drug Incentives: Legislative incentives continue to underpin investment in rare disease therapies, supporting sustained R&D financing.
• Personalized Medicine: Biomarker-driven devices and therapies foster tailored treatment approaches, potentially commanding premium pricing.
• Digital Health Integration: Remote monitoring and data collection facilitate post-market surveillance, enhance patient adherence, and generate real-world evidence to support reimbursement.

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Key Takeaways

• TIGLUTIK KIT's innovative enzyme replacement therapy fills a vital clinical gap for PKU, constituting a high-growth niche within the orphan drug landscape.
• Rapid market uptake, combined with expanded indications and regions, is poised to drive revenue growth at a CAGR of approximately 15% over the next five years.
• Market access strategies, including payor negotiations and value-based pricing, are critical to maximizing long-term revenues.
• Competitive threats from gene therapies necessitate continuous innovation and lifecycle management.
• Financial success hinges on balancing high manufacturing costs with operational efficiency and expanding payer acceptance.

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FAQs

1. What factors influence the pricing strategy for TIGLUTIK KIT?
Pricing considers clinical efficacy, manufacturing costs, market exclusivity, payer willingness-to-pay, and comparative therapies. Orphan drug status confers premium pricing opportunities due to limited alternatives, but payor negotiations focus heavily on demonstrated value.

2. How does TIGLUTIK KIT compare to emerging gene therapies for PKU?
While gene therapies promise potential curative benefits, they are still in clinical development phases and face regulatory hurdles. TIGLUTIK KIT offers a proven, safe, and scalable treatment option with established reimbursement pathways, maintaining its market relevance.

3. What is the impact of expanded indications on TIGLUTIK KIT's financial trajectory?
Broadened indications, such as younger age groups or milder phenotypes, will increase patient eligibility, driving revenue growth. However, this may also entail additional clinical studies and regulatory filings, influencing costs.

4. How do reimbursement challenges affect TIGLUTIK KIT sales?
High prices may lead to payer resistance, particularly in publicly funded healthcare systems, potentially restricting access. Effective negotiation, demonstrating cost-effectiveness, and patient assistance programs are vital to improve coverage.

5. What role do regional approvals play in TIGLUTIK KIT's global revenue?
Regional approvals expand the market, but variations in regulatory requirements, healthcare infrastructure, and pricing caps may affect rollout speed and profitability across regions.

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References

[1] BioMarin Pharmaceuticals Inc. Annual Report 2022.
[2] Evaluate Pharma. Orphan Drug Market Forecasts 2023-2028.
[3] FDA Approval Announcement for TIGLUTIK KIT, 2020.
[4] Pharma Intelligence. PKU Market Dynamics and Epidemiology, 2022.
[5] MarketWatch. Global Orphan Drug Market Outlook 2023.