TYLENOL Drug Patent Profile

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

A generic version of TYLENOL was approved as acetaminophen; codeine phosphate by WES PHARMA INC on June 27^th, 2019.

US Patents:	0
Applicants:	3
NDAs:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	179
Clinical Trials:	332
Patent Applications:	3,399
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for TYLENOL
DailyMed Link:	TYLENOL at DailyMed

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

Sponsor	Phase
University of Miami	Phase 2
Mayo Clinic	Phase 4
Hamilton Health Sciences Corporation	Phase 3

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

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

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

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Country	Patent Number	Title	Estimated Expiration
South Africa	8805460		⤷ Try a Trial
New Zealand	225402	ORAL SUSTAINED RELEASE ACETAMINOPHEN FORMULATIONS	⤷ Try a Trial
Ireland	882286		⤷ Try a Trial
Germany	3880762		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration