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BENADRYL

NDA

DIPHENHYDRAMINE HYDROCHLORIDE | N006146 | MCNEIL CONSUMER HEALTHCARE

2 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Emcure Pharmaceuticals USA Inc. - Citizen Petition FDA-2013-P-0336 · 3 docket documents Emcure Pharmaceuticals USA Inc. filed this petition requesting that the FDA accept Abbreviated New Drug Applications (ANDAs) for Diphenhydramine Hydrochloride Injection USP, 50 mg/mL in single-dose vial and multi-dose vial formulations. The petitioner seeks approval to reference the discontinued Ben	Other	2013-04-04	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

137 trials from ClinicalTrials.gov — 1 recruiting, 7 active, 99 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis NCT04221477	Phase 3	Active	Hoffmann-La Roche	271	2020-08-10 → 2031-03-02
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma NCT04270409	Phase 3	Active	Sanofi	337	2020-06-16 → 2033-10-21
Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia NCT03805932	Phase 1	Active	National Cancer Institute (NCI)	18	2019-10-03 → 2029-06-30
Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia NCT01059786	Phase 2	Active	National Cancer Institute (NCI)	69	2010-07-01 → 2027-12-31
A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma NCT04268498	Phase 2	Active	University of Miami	310	2020-02-11 → 2027-02-01
Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT NCT00840853	Phase 1	Active	Baylor College of Medicine	68	2009-04 → 2031-04
Chicago Social Drinking Project NCT00961792	N/A	Active	University of Chicago	800	2004-03 → 2027-10
Stem Cell Transplantation in Crohn's Disease NCT04224558	Phase 1/2	Recruiting	Cedars-Sinai Medical Center	15	2019-11-15 → 2027-09-30
Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer NCT03107182	Phase 2	Completed	University of Chicago	72	2017-06-27 → 2024-09-06
Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep NCT04093271	Phase 1	Completed	LifeSeasons Inc.	27	2019-09-24 → 2019-12-23

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

API Supply Chain6 active DMFs6 inactive

6 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

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 437752026

GANES CHEMICALS INC PENNSVILLE DIVInactiveDIPHENHYDRAMINE HYDROCHLORIDE

DMF 12371968

FOURTH PHARMACEUTICAL WORKSInactiveDIPHENHYDRAMINE, BULK FORM (SYNTHESIS)

DMF 40741981

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 (2)

Sort:

#001 — 10MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982