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Last Updated: November 21, 2024

Diphenhydramine hydrochloride - Generic Drug Details

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What are the generic sources for diphenhydramine hydrochloride and what is the scope of patent protection?

Diphenhydramine hydrochloride is the generic ingredient in seventeen branded drugs marketed by Mcneil Cons, Alra, Anabolic, Elkins Sinn, Fosun Pharma, Halsey, Heather, Heritage Pharma, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lederle, LNK, Mk Labs, Mutual Pharm, Newtron Pharms, Nexgen Pharma Inc, Perrigo, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Teva, Valeant Pharm Intl, Vangard, Watson Labs, Whiteworth Town Plsn, Cenci, Usl Pharma, Bundy, Kv Pharm, Naska, Pharm Assoc, Alpharma Us Pharms, App Pharms, Bel Mar, Dr Reddys, Gland Pharma Ltd, Hikma, Hospira, Lyphomed, Micro Labs, Mylan Institutional, West-ward Pharms Int, Wyeth Ayerst, Abraxis Pharm, Fresenius Kabi Usa, Intl Medication, Parke Davis, Morton Grove, Cumberland Swan, Sciegen Pharms Inc, Lannett Co Inc, Warner Chilcott, Haleon Us Holdings, Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Bayer Hlthcare, Amneal Pharms Co, Corepharma, Granules, P And L, and Perrigo R And D, and is included in one hundred NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for diphenhydramine hydrochloride. Fourteen suppliers are listed for this compound.

Summary for diphenhydramine hydrochloride

US Patents:	0
Tradenames:	17
Applicants:	67
NDAs:	100
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	304
What excipients (inactive ingredients) are in diphenhydramine hydrochloride?	diphenhydramine hydrochloride excipients list
DailyMed Link:	diphenhydramine hydrochloride at DailyMed

Drug Sales Revenue Trends for diphenhydramine hydrochloride

See drug sales revenues for diphenhydramine hydrochloride

Recent Clinical Trials for diphenhydramine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alabama at Birmingham	Phase 1
Assertio Holdings, Inc	Phase 2
Washington University School of Medicine	Phase 2

See all diphenhydramine hydrochloride clinical trials

Pharmacology for diphenhydramine hydrochloride

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for diphenhydramine hydrochloride

Anesthetics, Local
Anti-Allergic Agents
Antiemetics
Histamine H1 Antagonists
Hypnotics and Sedatives
Sleep Aids, Pharmaceutical

Anatomical Therapeutic Chemical (ATC) Classes for diphenhydramine hydrochloride

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for diphenhydramine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fosun Pharma	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	080832-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alpharma Us Pharms	HYDRAMINE	diphenhydramine hydrochloride	ELIXIR;ORAL	080763-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	089488-001	Jan 2, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	INJECTABLE;INJECTION	083533-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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