NDAINJECTIONINJECTABLE
Approved
Aug 1952
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
BENTYL PRESERVATIVE FREE (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 PRESERVATIVE FREE is an injectable dicyclomine hydrochloride formulation for treating functional bowel/irritable bowel syndrome. It works through dual mechanism: anticholinergic (antimuscarinic) effects at acetylcholine receptors and direct musculotropic effects on smooth muscle. The preservative-free formulation represents a specialized variant of a 70-year-old drug class.
LOE Approaching
Product approaching loss of exclusivity with minimal current spending signals a declining commercial footprint and likely smaller, consolidating team.
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.