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-one 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.
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Questions you can ask:
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Summary for SUDAFED 24 HOUR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 11 |
| Patent Applications: | 1,488 |
| 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 |
| National Center for Advancing Translational Science (NCATS) | Early Phase 1 |
| Vanderbilt University | Early Phase 1 |
Pharmacology for SUDAFED 24 HOUR
| Drug Class | alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| J And J Consumer Inc | SUDAFED 24 HOUR | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020021-002 | Dec 15, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Spain | 2025668 | ⤷ Sign Up | |
| Ireland | 56606 | OSMOTIC SYSTEM WITH INSTANT DRUG AVAILABILITY | ⤷ Sign Up |
| Sweden | 8401185 | ⤷ Sign Up | |
| Denmark | 162470 | ⤷ Sign Up | |
| Belgium | 898820 | ⤷ Sign Up | |
| European Patent Office | 0279976 | PSEUDOEPHEDRINE DOSAGE FORM | ⤷ Sign Up |
| Norway | 170667 | ⤷ Sign Up | |
| >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 | 08C0004 | France | ⤷ Sign Up | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 |
| 1110543 | SPC/GB08/005 | United Kingdom | ⤷ Sign Up | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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