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Last Updated: April 14, 2021

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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, Eurohlth Intl Sarl, Hospira, Lyphomed, Micro Labs, Mylan Institutional, West-ward Pharms Int, Wyeth Ayerst, Abraxis Pharm, Fresenius Kabi Usa, Intl Medication, Parke Davis, Morton Grove, Akorn, Cumberland Swan, Lannett Co Inc, Warner Chilcott, Glaxosmithkline, Aurobindo Pharma Ltd, Bionpharma Inc, Strides Pharma, Bayer Hlthcare, Amneal Pharms Co, Apotex, Granules, P And L, and Perrigo R And D, and is included in ninety-nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for diphenhydramine hydrochloride. Twelve suppliers are listed for this compound.

Summary for diphenhydramine hydrochloride
US Patents:2
Tradenames:17
Applicants:66
NDAs:99
Drug Master File Entries: 23
Suppliers / Packagers: 12
Bulk Api Vendors: 114
Clinical Trials: 265
Patent Applications: 7,309
Formulation / Manufacturing:see details
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

SponsorPhase
Aalborg UniversityN/A
City of Hope Medical CenterPhase 1
University of Colorado, DenverPhase 4

See all diphenhydramine hydrochloride clinical trials

Pharmacology for diphenhydramine hydrochloride
Medical Subject Heading (MeSH) Categories for diphenhydramine hydrochloride

US Patents and Regulatory Information for diphenhydramine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pvt Form DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride ELIXIR;ORAL 085287-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride ELIXIR;ORAL 083237-001 Jan 25, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Valeant Pharm Intl DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 080592-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 080868-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharma DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 080738-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Mcneil Cons BENADRYL PRESERVATIVE FREE diphenhydramine hydrochloride INJECTABLE;INJECTION 009486-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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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