Last reviewed · How we verify
DEXTROMETHORPHAN HYDROBROMIDE
Dextromethorphan Hydrobromide is a marketed drug primarily indicated for nasal congestion relief, with a key composition patent expiring in 2028. Its primary strength lies in its established market presence and long-standing use for nasal congestion. The primary risk is the potential increase in competition following the patent expiry in 2028.
At a glance
| Generic name | DEXTROMETHORPHAN HYDROBROMIDE |
|---|---|
| Drug class | Expectorant [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1984 |
Approved indications
- Nasal Congestion Relief
- Sinus Congestion and Pressure Relief
- Cough Relief
- Pain Relief
- Headache Relief
- Fever Reduction
- Sore Throat Relief
- Reduction of Nasal Swelling
- Improved Nasal Breathing
- Nasal and Sinus Drainage
- Phlegm Loosening
- Productive Cough Promotion
Common side effects
Key clinical trials
- Dextromethorphan for Treatment of Postoperative Pain (NA)
- Psilocybin-facilitated Treatment for Chronic Pain (EARLY_PHASE1)
- KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism (NA)
- Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia (PHASE2, PHASE3)
- Investigation of Psychedelic Effects in Psychoactive Substances (PHASE1)
- A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin (PHASE4)
- An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study (PHASE3)
- Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates (PHASE1)
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:
- DEXTROMETHORPHAN HYDROBROMIDE CI brief — competitive landscape report
- DEXTROMETHORPHAN HYDROBROMIDE updates RSS · CI watch RSS