Last reviewed · How we verify
PHENYLPROPANOLAMINE HYDROCHLORIDE
Phenylpropanolamine Hydrochloride is a marketed drug with a key composition patent expiring in 2028. The drug's market position and primary indication are not specified, but the patent expiry presents a significant competitive advantage by maintaining exclusivity until 2028. The primary risk is the potential for increased competition post-patent expiry in 2028.
At a glance
| Generic name | PHENYLPROPANOLAMINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1958 |
Approved indications
Common side effects
Key clinical trials
- A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement (PHASE3)
- Preventing Frequent Sinus Infections in HIV-Infected Patients (PHASE2)
- Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI (PHASE4)
- Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion (PHASE3)
- Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions (PHASE1)
- A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms (PHASE1)
- Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections. (PHASE3)
- Phase 4 Study - Mucinex D as Adjunct Therapy (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PHENYLPROPANOLAMINE HYDROCHLORIDE CI brief — competitive landscape report
- PHENYLPROPANOLAMINE HYDROCHLORIDE updates RSS · CI watch RSS