TYLENOL W/ CODEINE Drug Patent Profile

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-two 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 SUN PHARM INDS LTD on December 31^st, 1969.

Summary for TYLENOL W/ CODEINE

US Patents:	0
Applicants:	2
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	24
Patent Applications:	7
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
Eurofarma Laboratorios S.A.	Phase 3
University of Toronto	Phase 4
Humber River Hospital	Phase 4

See all TYLENOL W/ CODEINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TYLENOL W/ CODEINE

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

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	Yes	No
Janssen Pharms	TYLENOL W/ CODEINE NO. 2	acetaminophen; codeine phosphate	TABLET;ORAL	085055-002	Approved Prior to Jan 1, 1982		DISCN	Yes	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