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BENADRYL

NDA

DIPHENHYDRAMINE HYDROCHLORIDE | N005845 | MCNEIL CONSUMER HEALTHCARE

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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)NCT06170788	Phase 3	Recruiting	Merck Sharp & Dohme LLC	614	2023-12-15 → 2030-05-27
KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C)NCT04165096	Phase 2	Completed	Merck Sharp & Dohme LLC	128	2020-01-21 → 2025-05-28

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain5 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

BEIJING TAIYANG PHARMACEUTICAL INDUSTRY CO LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 197372006

WANBURY LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 205722007

SUPRIYA LIFESCIENCE LTDDIPHENHYDRAMINE HYDROCHLORIDE USP

DMF 351742020

GLAND PHARMA LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 359532021

S. S. PHARMACHEMDIPHENHYDRAMINE

DMF 421072025

GANES CHEMICALS INC PENNSVILLE DIVInactiveDIPHENHYDRAMINE HYDROCHLORIDE

DMF 12371968

UNICHEM LABORATORIES LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE

DMF 56531984

UNICHEM LABORATORIES LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE

DMF 76611988

KAMUD DRUGS PVT LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE USP

DMF 226012009

SOUVIN PHARMACEUTICAL I PVT LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE USP

DMF 267722012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (3)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#004 — 12.5MG/5ML

0 patents0 exclusivities▾

ELIXIR;ORAL | Approved: Approved Prior to Jan 1, 1982

#007 — 25MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982