SUDAFED Drug Patent Profile
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Which patents cover Sudafed, and when can generic versions of Sudafed launch?
Sudafed is a drug marketed by Glaxosmithkline, Mcneil Cons, and Kenvue Brands. and is included in three NDAs.
The generic ingredient in SUDAFED is pseudoephedrine hydrochloride. There are forty-nine drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sudafed
A generic version of SUDAFED was approved as pseudoephedrine hydrochloride by L PERRIGO CO on February 26th, 1999.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for SUDAFED?
- What are the global sales for SUDAFED?
- What is Average Wholesale Price for SUDAFED?
Summary for SUDAFED
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Sales Revenues: | Drug sales revenues for SUDAFED |
| What excipients (inactive ingredients) are in SUDAFED? | SUDAFED excipients list |
| DailyMed Link: | SUDAFED at DailyMed |
US Patents and Regulatory Information for SUDAFED
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mcneil Cons | SUDAFED 12 HOUR | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 073585-001 | Oct 31, 1991 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Kenvue Brands | SUDAFED 24 HOUR | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020021-002 | Dec 15, 1992 | DISCN | Yes | No | ⤷ 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 |

