Diphenhydramine hydrochloride; naproxen sodium - Generic Drug Details

What are the generic drug sources for diphenhydramine hydrochloride; naproxen sodium and what is the scope of patent protection?

Diphenhydramine hydrochloride; naproxen sodium is the generic ingredient in two branded drugs marketed by Bayer Hlthcare, Amneal Pharms Co, Corepharma, Granules, P And L, and Perrigo R And D, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-two suppliers are listed for this compound.

Summary for diphenhydramine hydrochloride; naproxen sodium

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	22
Clinical Trials:	9
DailyMed Link:	diphenhydramine hydrochloride; naproxen sodium at DailyMed

Recent Clinical Trials for diphenhydramine hydrochloride; naproxen sodium

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

Sponsor	Phase
Ciusss de L'Est de l'Île de Montréal	N/A
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2

See all diphenhydramine hydrochloride; naproxen sodium clinical trials

Pharmacology for diphenhydramine hydrochloride; naproxen sodium

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for diphenhydramine hydrochloride; naproxen sodium

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for diphenhydramine hydrochloride; naproxen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Perrigo R And D	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	208499-001	May 10, 2019		OTC	No	No
Amneal Pharms Co	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	209726-001	Oct 23, 2018		OTC	No	No
Corepharma	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	211830-001	Aug 22, 2019		OTC	No	No
Granules	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	213663-001	Sep 24, 2020		OTC	No	No
Bayer Hlthcare	ALEVE PM	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	205352-001	Jan 17, 2014		OTC	Yes	Yes