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Last Updated: August 19, 2022

SUDAFED 24 HOUR Drug Patent Profile


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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.

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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 See Plans and Pricing
Mexico 9203560 UNA FORMA DE DOSIS PARA SURTIR PSEUDOEFEDRINA. See Plans and Pricing
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 See Plans and Pricing
Japan S63258409 PSEUDOEPHEDRINE ADMINISTRATIVE MEDICINE See Plans and Pricing
Germany 3407873 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SUDAFED 24 HOUR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 SPC/GB08/005 United Kingdom See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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