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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-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for TYLENOL W/ CODEINE

US Patents:	0
Applicants:	2
NDAs:	5
Clinical Trials:	20
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
University of South Florida	N/A
Mahidol University	Phase 2
Children's Hospital of Michigan Foundation	N/A

See all TYLENOL W/ CODEINE clinical trials

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
Janssen Pharms	TYLENOL W/ CODEINE NO. 2	acetaminophen; codeine phosphate	TABLET;ORAL	085055-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Ortho Mcneil Pharm	TYLENOL W/ CODEINE	acetaminophen; codeine phosphate	TABLET;ORAL	085056-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Ortho Mcneil Pharm	TYLENOL W/ CODEINE NO. 3	acetaminophen; codeine phosphate	CAPSULE;ORAL	087422-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ortho Mcneil Pharm	TYLENOL W/ CODEINE	acetaminophen; codeine phosphate	TABLET;ORAL	085056-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ortho Mcneil Pharm	TYLENOL W/ CODEINE	acetaminophen; codeine phosphate	TABLET;ORAL	085056-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Janssen Pharms	TYLENOL W/ CODEINE NO. 1	acetaminophen; codeine phosphate	TABLET;ORAL	085055-001	Approved Prior to Jan 1, 1982		DISCN	No	No