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Last Updated: June 6, 2020

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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, Cumberland Swan, Hi Tech Pharma, Lannett Co Inc, Warner Chilcott, Glaxosmithkline, Aurobindo Pharma Ltd, Bionpharma Inc, Strides Pharma, Bayer Hlthcare, Amneal Pharms Co, Apotex, P And L, and Perrigo R And D, and is included in ninety-eight 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. Sixteen suppliers are listed for this compound.

Drug Sales Revenue Trends for diphenhydramine hydrochloride

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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
Perrigo ANTITUSSIVE diphenhydramine hydrochloride SYRUP;ORAL 071292-001 Apr 10, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Anabolic DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 083275-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Perrigo R And D NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; naproxen sodium TABLET;ORAL 208499-001 May 10, 2019 OTC No No   Start Trial   Start Trial   Start Trial
Nexgen Pharma Inc DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 083634-001 Approved Prior to Jan 1, 1982 DISCN No 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
McKinsey
Dow
Merck
Harvard Business School

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