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Last Updated: November 2, 2024

DIPHENHYDRAMINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Diphenhydramine Hydrochloride, and when can generic versions of Diphenhydramine Hydrochloride launch?

Diphenhydramine Hydrochloride is a drug marketed by 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, Bundy, Cenci, Kv Pharm, Naska, Pharm Assoc, App Pharms, Bel Mar, Dr Reddys, Gland Pharma Ltd, Hikma, Hospira, Lyphomed, Micro Labs, Mylan Institutional, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Sciegen Pharms Inc, Abraxis Pharm, Fresenius Kabi Usa, and Intl Medication. and is included in seventy-five NDAs.

The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Diphenhydramine Hydrochloride

A generic version of DIPHENHYDRAMINE HYDROCHLORIDE was approved as diphenhydramine hydrochloride by WEST-WARD PHARMS INT on December 31st, 1969.

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Summary for DIPHENHYDRAMINE HYDROCHLORIDE
Drug patent expirations by year for DIPHENHYDRAMINE HYDROCHLORIDE
Drug Sales Revenue Trends for DIPHENHYDRAMINE HYDROCHLORIDE

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Recent Clinical Trials for DIPHENHYDRAMINE HYDROCHLORIDE

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

SponsorPhase
University of Alabama at BirminghamPhase 1
Washington University School of MedicinePhase 2
Assertio Holdings, IncPhase 2

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
Dr Reddys DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride INJECTABLE;INJECTION 080873-001 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
Perrigo DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 083061-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abraxis Pharm DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE diphenhydramine hydrochloride INJECTABLE;INJECTION 080586-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vangard DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 088034-001 Oct 27, 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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