TYLENOL Drug Patent Profile

Which patents cover Tylenol, and what generic alternatives are available?

Tylenol is a drug marketed by J And J Consumer Inc, Ortho Mcneil Pharm, and Janssen Pharms. and is included in seven NDAs.

The generic ingredient in TYLENOL is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty 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

A generic version of TYLENOL was approved as acetaminophen; codeine phosphate by SUN PHARM INDS LTD on December 31^st, 1969.

Summary for TYLENOL

US Patents:	0
Applicants:	3
NDAs:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	165
Clinical Trials:	329
Patent Applications:	6,294
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for TYLENOL
DailyMed Link:	TYLENOL at DailyMed

See drug sales revenues for TYLENOL

Recent Clinical Trials for TYLENOL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hamilton Health Sciences Corporation	Phase 3
McMaster University	Phase 3
Baylor College of Medicine	Phase 4

See all TYLENOL clinical trials

US Patents and Regulatory Information for TYLENOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
J And J Consumer Inc	TYLENOL	acetaminophen	SUPPOSITORY;RECTAL	017756-002	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
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-002	Jan 11, 2001		OTC	Yes	Yes
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	085056-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Ortho Mcneil Pharm	TYLENOL W/ CODEINE NO. 4	acetaminophen; codeine phosphate	CAPSULE;ORAL	087421-001	Approved Prior to Jan 1, 1982		DISCN	No	No
J And J Consumer Inc	TYLENOL	acetaminophen	SUPPOSITORY;RECTAL	017756-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for TYLENOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994

International Patents for TYLENOL

See the table below for patents covering TYLENOL around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	62831	Orally sustained-release acetaminophen formulation and process to obtain it
European Patent Office	0305051	ORALLY SUSTAINED-RELEASE ACETAMINOPHEN FORMULATION AND PROCESS TO OBTAIN IT
Australia	611704
Japan	2720932
Germany	3880762
South Africa	8805460
New Zealand	225402	ORAL SUSTAINED RELEASE ACETAMINOPHEN FORMULATIONS