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 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GRALISE is an oral gabapentin tablet approved in 2011 for neuropathic pain management. It works by binding to voltage-activated calcium channel subunits and potentially blocking thrombospondin-mediated excitatory synapse formation, reducing allodynia and hyperalgesia. The mechanism prevents abnormal pain signaling in neuropathic conditions without directly modulating GABA receptors.
$0.023BPart D
LOE ApproachingProduct approaching loss of exclusivity with moderate Part D spending; marketing teams should prepare for generic transition and cost-containment strategies.
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…
Worked on GRALISE at Almatica Pharma? Share your interview experience or compensation data (+7 days Pro)
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.