Last reviewed · How we verify
DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride is a marketed antihistamine with a well-established presence in the over-the-counter (OTC) market. The key composition patent is set to expire in 2028, providing a significant period of market exclusivity. The primary risk is the potential increase in generic competition following the patent expiry.
At a glance
| Generic name | DIPHENHYDRAMINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1946 |
Approved indications
Common side effects
Key clinical trials
- Trial of Diphenhydramine for Sleep in Children With Autism (PHASE2)
- Trial of Zolpidem for Sleep in Children With Autism (PHASE2)
- Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007) (PHASE3)
- A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma (PHASE2)
- A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003) (PHASE1, PHASE2)
- Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer (PHASE2)
- Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG) (PHASE1)
- IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patient's Quality Of Life (NA)
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:
- DIPHENHYDRAMINE HYDROCHLORIDE CI brief — competitive landscape report
- DIPHENHYDRAMINE HYDROCHLORIDE updates RSS · CI watch RSS