Wednesday, July 8, 2026

Drug profile · INN

diphenhydramine hydrochloride

diphenhydramine hydrochloride (DIPHENHYDRAMINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 20
Pipeline programs 34
News articles 0
Drug details — diphenhydramine hydrochloride
US status
approved
Class
Route
INJECTION
Patents
20
Programs
34
Data quality
0.89

Quick answer

diphenhydramine hydrochloride (DIPHENHYDRAMINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN diphenhydramine hydrochloride
Brand DIPHENHYDRAMINE HYDROCHLORIDE
Mechanism Histamine H1 receptor antagonist
Target Histamine H1 receptor
Route INJECTION
Formulation CAPSULE

Mechanism of action

Histamine H1 receptor antagonist

Primary target: Histamine H1 receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 299IG301 Phase 3 · Biogen · IgA nephropathy
  2. BN42082 Phase 3 · HOFFMANN-LA ROCHE · Relapsing Multiple Sclerosis (MS)
  3. BN42083 Phase 3 · HOFFMANN-LA ROCHE · Primary Progressive Multiple Sclerosis (PPMS)
  4. CA41705 Phase 3 · HOFFMANN-LA ROCHE · Lupus Nephritis (LN)
  5. EFC15992 Phase 3 · Sanofi-Aventis U.S · Plasma cell myeloma
  6. GCT3013-05 Phase 3 · Genmab · B-cell Lymphoma
  7. M22-574 Phase 3 · AbbVie Deutschland GmbH · Relapsed or Refractory Multiple Myeloma (RRMM)
  8. MN39158 Phase 3 · HOFFMANN-LA ROCHE · Multiple sclerosis (MS)

Related & competitor drugs

  1. azelastine hydrochloride Histamine H1 receptor antagonist
  2. brompheniramine maleate Histamine H1 receptor antagonist
  3. carbinoxamine maleate Histamine H1 receptor antagonist
  4. cetirizine hydrochloride Histamine H1 receptor antagonist
  5. chlorpheniramine maleate Histamine H1 receptor antagonist
  6. clemastine fumarate Histamine H1 receptor antagonist
  1. US 12331126

    OX40-binding polypeptides and uses thereof

    Expires Mon Jun 12 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12084502

    CD33-binding polypeptides and uses thereof

    Expires Mon Sep 05 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12043667

    CLEC12a binding polypeptides and uses thereof

    Expires Mon Jul 18 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12012459

    OX40-binding polypeptides and uses thereof

    Expires Mon Jun 13 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11965017

    Serpin fusion polypeptides and methods of use thereof

    Expires Mon Apr 18 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11919963

    CD123-binding polypeptides and uses thereof

    Expires Mon Feb 29 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11866507

    Multispecific polypeptide constructs having constrained CD3 binding and methods of using the same

    Expires Mon Jan 04 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11827691

    Serpin fusion polypeptides and methods of use thereof

    Expires Mon Nov 23 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11566078

    PDL1-binding proteins

    Expires Mon Jan 26 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 11560428

    CD33-binding polypeptides and uses thereof

    Expires Mon Jan 19 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 11434297

    CD123-binding polypeptides and uses thereof

    Expires Mon Sep 01 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 11046752

    Serpin fusion polypeptides and methods of use thereof

    Expires Mon Jun 24 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 10745466

    Type III secretion system targeting molecules

    Expires Mon Aug 13 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 10730929

    Serpin fusion polypeptides and methods of use thereof

    Expires Mon Jul 30 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 10723785

    Serpin fusion polypeptides and methods of use thereof

    Expires Mon Jul 23 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 10400029

    Serpin fusion polypeptides and methods of use thereof

    Expires Mon Aug 29 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 10344078

    Type III secretion system targeting molecules

    Expires Mon Jul 04 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 10093742

    Multispecific GITR-binding fusion proteins and methods of use thereof

    Expires Mon Oct 04 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 9920109

    Serpin fusion polypeptides and methods of purification thereof

    Expires Mon Mar 15 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 9914765

    WAP domain fusion polypeptides and methods of use thereof

    Expires Mon Mar 08 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is diphenhydramine hydrochloride?

diphenhydramine hydrochloride (DIPHENHYDRAMINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for diphenhydramine hydrochloride?

DIPHENHYDRAMINE HYDROCHLORIDE is a marketed brand name for diphenhydramine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of diphenhydramine hydrochloride?

diphenhydramine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.