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Last Updated: April 24, 2024

DIPHEN Drug Patent Profile

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

Diphen is a drug marketed by Usl Pharma, Morton Grove, 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, Eurohlth Intl Sarl, Hospira, Lyphomed, Micro Labs, Mylan Institutional, West-ward Pharms Int, Wyeth Ayerst, Akorn, Alpharma Us Pharms, Cumberland Swan, Abraxis Pharm, Fresenius Kabi Usa, Intl Medication, Hikma, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Chartwell Rx, Dr Reddys Labs Sa, Inwood Labs, Leading, Mylan, Parke Davis, R And S Pharma, Specgx Llc, Strides Pharma, Upsher Smith Labs, Winder Labs Llc, Scherer Rp, and Chartwell Molecular. and is included in one hundred and six NDAs.

The generic ingredient in DIPHEN is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diphen

A generic version of DIPHEN was approved as phenytoin sodium by WEST-WARD PHARMS INT on December 31^st, 1969.

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Summary for DIPHEN

US Patents:	0
Applicants:	70
NDAs:	106
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	2
Patent Applications:	1,760
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DIPHEN
Drug Sales Revenues:	Drug sales revenues for DIPHEN
DailyMed Link:	DIPHEN at DailyMed

Drug patent expirations by year for DIPHEN

Drug Prices for DIPHEN

Recent Clinical Trials for DIPHEN

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Sponsor	Phase
Hospira, Inc.	Phase 4
University of Pennsylvania	Phase 4
Hospira, now a wholly owned subsidiary of Pfizer	Phase 4

See all DIPHEN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DIPHEN

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 DIPHEN

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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
App Pharms	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	INJECTABLE;INJECTION	040466-001	May 28, 2002	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Inwood Labs	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085509-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pvt Form	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	083027-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Newtron Pharms	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	086544-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cumberland Swan	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	SYRUP;ORAL	073611-001	Aug 20, 1992		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	210571-001	Aug 31, 2018		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Valeant Pharm Intl	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	080596-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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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