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 Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BENTYL (dicyclomine hydrochloride) is an oral anticholinergic agent approved in 1951 for functional bowel disorder and irritable bowel syndrome. It works through dual mechanism: antimuscarinic activity at acetylcholine receptors (approximately 1/8 the potency of atropine) and direct smooth muscle relaxation. The combination produces antispasmodic effects with minimal systemic anticholinergic side effects.
$0.051MPart D
LOE ApproachingDeclining
Small, stable team managing legacy brand with minimal growth opportunity; career risk if employed on brand team due to approaching LOE and limited claims.
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.