SUDAFED 24 HOUR Drug Patent Profile

When do Sudafed 24 Hour patents expire, and what generic alternatives are available?

Sudafed 24 Hour is a drug marketed by J And J Consumer Inc and is included in one NDA.

The generic ingredient in SUDAFED 24 HOUR is pseudoephedrine hydrochloride. There are forty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sudafed 24 Hour

A generic version of SUDAFED 24 HOUR was approved as pseudoephedrine hydrochloride by L PERRIGO CO on February 26^th, 1999.

Summary for SUDAFED 24 HOUR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	10
Patent Applications:	1,413
Formulation / Manufacturing:	see details
DailyMed Link:	SUDAFED 24 HOUR at DailyMed

Recent Clinical Trials for SUDAFED 24 HOUR

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1
National Center for Advancing Translational Science (NCATS)	Early Phase 1
Vanderbilt University	Early Phase 1

See all SUDAFED 24 HOUR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SUDAFED 24 HOUR

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular 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 SUDAFED 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992		OTC	Yes	Yes

Expired US Patents for SUDAFED 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992

International Patents for SUDAFED 24 HOUR

See the table below for patents covering SUDAFED 24 HOUR around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	8400259
Mexico	9203560	UNA FORMA DE DOSIS PARA SURTIR PSEUDOEFEDRINA.
Italy	1182253	DISPOSITIVO AD AZIONE OSMOTICA PER LA SOMMINISTRAZIONE DI UN AGENTE BENEFICO ALL AMBIENTE CIRCOSTANTE PARTICOLARMENTE PER LA SOMMINISTRAZIONE DI FARMACI IN AMBITO GASTROINTE STINALE
Japan	S63258409	PSEUDOEPHEDRINE ADMINISTRATIVE MEDICINE
Germany	3407873

Supplementary Protection Certificates for SUDAFED 24 HOUR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730