NDAORALSUSPENSION
Approved
Sep 2018
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
5/8 — Partial
Drug Shortage Active
TIGLUTIK KIT is currently in shortage. Reason: Unavailable. This may impact manufacturing, supply chain, and quality hiring at the manufacturer.
TIGLUTIK KIT (riluzole) by Italfarmaco Research is 12. Approved for amyotrophic lateral sclerosis. First approved in 2018.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIGLUTIK KIT is an oral suspension formulation of riluzole, a benzothiazole small molecule indicated for amyotrophic lateral sclerosis (ALS). The mechanism of action remains unknown, though riluzole is believed to modulate neuronal excitability in ALS patients. This is a re-formulation of the original tablet-based RILUTEK, designed for improved patient administration.
LOE Approaching2.9 years to LOE
TIGLUTIK is approaching loss of exclusivity (LOE) in 2.9 years, signaling a contraction phase requiring defensive positioning and likely reduced team investment as generic competition emerges.
Mechanism of Action
12.1 Mechanism of Action The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown. 12.2 Pharmacodynamics The clinical pharmacodynamics of riluzole has not been determined in humans. 12.3 Pharmacokinetics Table 2 displays the pharmacokinetic parameters of…
Pharmacologic Class:
Benzothiazole
Indications (1)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.