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SUDAFED 24 HOUR Drug Profile
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» See Plans and PricingWhen 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-one suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.
US ANDA 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 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 27 |
| Clinical Trials: | 9 |
| Patent Applications: | 1,321 |
| 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 |
|---|---|
| Vanderbilt University | Phase 0 |
| National Center for Advancing Translational Science (NCATS) | Phase 0 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 0 |
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 | Start Trial | Start Trial | Start Trial | ||||
| >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 | Start Trial | Start Trial |
| J And J Consumer Inc | SUDAFED 24 HOUR | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020021-002 | Dec 15, 1992 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SUDAFED 24 HOUR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 8400259 | Start Trial |
| Germany | 3774264 | Start Trial |
| Brazil | 8400997 | Start Trial |
| Netherlands | 8400670 | Start Trial |
| Spain | 8503499 | Start Trial |
| Belgium | 898820 | Start Trial |
| Austria | 396056 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SUDAFED 24 HOUR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1110543 | 08C0004 | France | Start Trial | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 |
| 1110543 | SPC/GB08/005 | United Kingdom | Start Trial | 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. |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
