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.
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 26th, 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 |
Anatomical Therapeutic Chemical (ATC) Classes for SUDAFED 24 HOUR
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 |