SUDAFED 24 HOUR Drug Patent Profile

« Back to Dashboard

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

Sudafed 24 Hour is a drug marketed by Kenvue Brands and is included in one NDA.

The generic ingredient in SUDAFED 24 HOUR is pseudoephedrine hydrochloride. There is one drug master file entry for this compound. Thirty 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:	1
Clinical Trials:	11
Patent Applications:	1,703
DailyMed Link:	SUDAFED 24 HOUR at DailyMed

Recent Clinical Trials for SUDAFED 24 HOUR

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

Sponsor	Phase
John Muir Health	N/A
Vanderbilt University	Early Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1

See all SUDAFED 24 HOUR clinical trials

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
Kenvue Brands	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992		DISCN	Yes	No

Expired US Patents for SUDAFED 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992
Kenvue Brands	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
Austria	396056
Austria	397179
Austria	A150889
Austria	A72784
Australia	2306884
Australia	568621
Belgium	898820

Supplementary Protection Certificates for SUDAFED 24 HOUR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
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.