SUDAFED 12 HOUR Drug Patent Profile
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When do Sudafed 12 Hour patents expire, and what generic alternatives are available?
Sudafed 12 Hour is a drug marketed by Glaxosmithkline and Mcneil Cons and is included in two NDAs.
The generic ingredient in SUDAFED 12 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 12 Hour
A generic version of SUDAFED 12 HOUR was approved as pseudoephedrine hydrochloride by L PERRIGO CO on February 26th, 1999.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SUDAFED 12 HOUR?
- What are the global sales for SUDAFED 12 HOUR?
- What is Average Wholesale Price for SUDAFED 12 HOUR?
Summary for SUDAFED 12 HOUR
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 11 |
| Patent Applications: | 1,488 |
| DailyMed Link: | SUDAFED 12 HOUR at DailyMed |
Recent Clinical Trials for SUDAFED 12 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 |
US Patents and Regulatory Information for SUDAFED 12 HOUR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | SUDAFED 12 HOUR | pseudoephedrine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 017941-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mcneil Cons | SUDAFED 12 HOUR | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 073585-001 | Oct 31, 1991 | DISCN | No | No | ⤷ 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 |
