DIPHENHYDRAMINE Drug Patent Profile

When do Diphenhydramine patents expire, and what generic alternatives are available?

Diphenhydramine 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, Avet Lifesciences, Bel Mar, Dr Reddys, Gland, Hikma, Hospira, Lyphomed, Micro Labs, Pharmobedient, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Sciegen Pharms, Abraxis Pharm, Fresenius Kabi Usa, and Intl Medication. and is included in seventy-eight NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diphenhydramine

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

Summary for DIPHENHYDRAMINE

US Patents:	0
Applicants:	52
NDAs:	78
Drug Prices:	Drug price information for DIPHENHYDRAMINE
DailyMed Link:	DIPHENHYDRAMINE at DailyMed

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US Patents and Regulatory Information for DIPHENHYDRAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avet Lifesciences	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	INJECTABLE;INJECTION	205337-001	Nov 14, 2025	AP	RX	No	No
Sun Pharm Industries	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	089488-001	Jan 2, 1987		DISCN	No	No
Perrigo	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	083061-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Alpharma Us Pharms	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	SYRUP;ORAL	070497-001	Apr 25, 1989		DISCN	No	No
Vangard	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	088034-001	Oct 27, 1982		DISCN	No	No