NDAORALTABLET
Approved
Jan 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
GRALISE (gabapentin) by Almatica Pharma is analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). First approved in 2011.
Drug data last refreshed 21h ago · AI intelligence enriched 23h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GRALISE is an extended-release oral tablet formulation of gabapentin, a small-molecule analgesic approved in 2011 for neuropathic pain management. It works by binding to voltage-activated calcium channel subunits and is hypothesized to block excitatory synapse formation, reducing allodynia and hyperalgesia. The drug does not interact with GABA receptors or major neurotransmitter systems despite structural similarity to GABA.
$23MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D utilization; commercial teams should prepare for generic competition and market contraction.
Mechanism of Action
analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). Gabapentin prevents pain-related responses in several models of neuropathic pain in rats and mice (e.g., spinal nerve ligation…
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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.