PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
LOE Approachingpromethazine hydrochloride and dextromethorphan hydrobromide
NDAORALSYRUP
Approved
Dec 1957
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (promethazine hydrochloride and dextromethorphan hydrobromide) by ANI Pharmaceuticals is clinical pharmacology promethazine promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. First approved in 1957.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Promethazine hydrochloride and dextromethorphan hydrobromide is a fixed-dose combination oral syrup that combines an H1 receptor antagonist with antihistaminic and sedative properties with a non-narcotic antitussive agent. The combination is indicated for cough suppression and allergy symptom relief, with promethazine providing antiemetic and sedative effects while dextromethorphan acts centrally to elevate the cough threshold. This is a legacy combination product approved in 1957 that remains in clinical use for symptomatic relief of cough and upper respiratory symptoms.
LOE Approaching
As a legacy product approaching loss of exclusivity with moderate competitive pressure (30%), the brand team is likely focused on cost management and market defense rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY PROMETHAZINE Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of…
Indications
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
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