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TYLENOL W/ CODEINE Drug Profile
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Which patents cover Tylenol W/ Codeine, and what generic alternatives are available?
Tylenol W/ Codeine is a drug marketed by Ortho Mcneil Pharm and Janssen Pharms and is included in five NDAs.
The generic ingredient in TYLENOL W/ CODEINE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tylenol W/ Codeine
A generic version of TYLENOL W/ CODEINE was approved as acetaminophen; codeine phosphate by VINTAGE on September 30th, 1988.
Summary for TYLENOL W/ CODEINE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 5 |
| Clinical Trials: | 21 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TYLENOL W/ CODEINE at DailyMed |
Recent Clinical Trials for TYLENOL W/ CODEINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Humber River Hospital | Phase 4 |
| University of South Florida | N/A |
| Mahidol University | Phase 2 |
US Patents and Regulatory Information for TYLENOL W/ CODEINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ortho Mcneil Pharm | TYLENOL W/ CODEINE | acetaminophen; codeine phosphate | SOLUTION;ORAL | 085057-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Janssen Pharms | TYLENOL W/ CODEINE NO. 2 | acetaminophen; codeine phosphate | TABLET;ORAL | 085055-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ortho Mcneil Pharm | TYLENOL W/ CODEINE | acetaminophen; codeine phosphate | TABLET;ORAL | 085056-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ortho Mcneil Pharm | TYLENOL W/ CODEINE NO. 3 | acetaminophen; codeine phosphate | CAPSULE;ORAL | 087422-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ortho Mcneil Pharm | TYLENOL W/ CODEINE | acetaminophen; codeine phosphate | TABLET;ORAL | 085056-001 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 |
