Naproxen sodium; pseudoephedrine hydrochloride - Generic Drug Details

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

Naproxen sodium; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Bayer, Aurobindo Pharma, Dr Reddys Labs Inc, and Perrigo, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for naproxen sodium; pseudoephedrine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	10
Clinical Trials:	2
DailyMed Link:	naproxen sodium; pseudoephedrine hydrochloride at DailyMed

Recent Clinical Trials for naproxen sodium; pseudoephedrine hydrochloride

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

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 1

See all naproxen sodium; pseudoephedrine hydrochloride clinical trials

Pharmacology for naproxen sodium; pseudoephedrine hydrochloride

Drug Class	Nonsteroidal Anti-inflammatory Drug alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Cyclooxygenase Inhibitors

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

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

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

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for naproxen sodium; pseudoephedrine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	naproxen sodium; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	211360-001	Jun 1, 2022		OTC	No	No
Dr Reddys Labs Inc	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	naproxen sodium; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077381-001	Sep 27, 2006		OTC	No	No
Bayer	ALEVE-D SINUS & COLD	naproxen sodium; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021076-001	Nov 29, 1999		DISCN	Yes	No
Perrigo	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	naproxen sodium; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076518-001	Mar 17, 2004		OTC	No	Yes