NDAORALSYRUP
Approved
Apr 1951
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
BENTYL (dicyclomine hydrochloride) by Teva is tract. Approved for functional bowel/irritable bowel syndrome (). First approved in 1951.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BENTYL (dicyclomine hydrochloride) is an oral anticholinergic/antispasmodic agent approved in 1951 for functional bowel disorder and irritable bowel syndrome. It works via dual mechanism: antimuscarinic activity at acetylcholine receptors (approximately 1/8 the potency of atropine) combined with direct smooth muscle relaxation effects. The drug reduces intestinal spasm and GI motility disturbances in patients with IBS.
$0.051MPart D
LOE ApproachingMature product with minimal spending ($51K Part D, 39 claims in 2023) and approaching loss of exclusivity, indicating shrinking team size and defensive positioning.
Mechanism of Action
tract. Animal studies indicate that this action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine ( in vitro , guinea pig ileum); and a direct effect upon smooth muscle…
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.