NDAORALCAPSULEPriority Review
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
LYRICA (pregabalin) by Viatris is (pregabalin) binds with high affinity to the alpha 2 -delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. First approved in 2004.
Drug data last refreshed 2m ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYRICA (pregabalin) is an oral small-molecule anticonvulsant and analgesic approved in 2004 that binds to alpha-2-delta subunits of voltage-gated calcium channels in the central nervous system. It is indicated for neuropathic pain, fibromyalgia, and seizure disorders by reducing pro-nociceptive neurotransmitter release and modulating descending pain pathways. The mechanism involves calcium channel disruption and interactions with brainstem noradrenergic and serotonergic systems rather than direct GABA receptor binding.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team consolidation and focus shift toward generic transition management.
Mechanism of Action
(pregabalin) binds with high affinity to the alpha 2 -delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds…
Indications
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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.