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
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	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
Amneal Pharms Co	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	209726-001	Oct 23, 2018		OTC	No	No
Perrigo R And D	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	208499-001	May 10, 2019		OTC	No	No
Corepharma	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	211830-001	Aug 22, 2019		OTC	No	No