NDAORALTABLET, EXTENDED RELEASE
Approved
Dec 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Drug data last refreshed 16h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUDAFED 24 HOUR is an extended-release oral tablet containing pseudoephedrine hydrochloride, a sympathomimetic decongestant used to relieve nasal congestion associated with colds, allergies, and sinusitis. It works by constricting blood vessels in the nasal passages to reduce swelling and improve airflow. This OTC product has been a staple in the decongestant market since its 1992 approval.
LOE Approaching
As an OTC product nearing loss of exclusivity with moderate competitive pressure (30%), the brand team is likely focused on defending market share through line extensions and consumer loyalty rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.
Started Jan 2015
53 enrolled
Common Cold
Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions
Started Dec 2014
80 enrolled
Healthy
Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets
Started Apr 2014
66 enrolled
Pain, HeadPain, AcutePain, Back+1 more
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions
Started Jul 2005
40 enrolled
Allergies
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions
Started Jun 2005
40 enrolled
Allergies
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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.