NDAINJECTIONINJECTABLE
Approved
Aug 1952
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
BENTYL (dicyclomine hydrochloride) by AbbVie is tract. Approved for functional bowel/irritable bowel syndrome (). First approved in 1952.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BENTYL (dicyclomine hydrochloride) is an anticholinergic/antispasmodic agent approved in 1952 for functional bowel disorder and irritable bowel syndrome. It works via dual mechanism: antimuscarinic activity at acetylcholine receptors (1/8 the potency of atropine) and direct smooth muscle relaxation, reducing intestinal spasms.
LOE Approaching
As an approaching LOE product with moderate competitive pressure (30), brand teams should expect contraction; focus shifts to margin defense and cost-efficiency initiatives rather than growth.
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.