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Last Updated: August 6, 2020

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TYLENOL Drug Profile

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Drug patent expirations by year for TYLENOL
Drug Sales Revenue Trends for TYLENOL

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Recent Clinical Trials for TYLENOL

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SponsorPhase
State University of New York at BuffaloPhase 3
National Institutes of Health (NIH)Phase 2
Tufts Medical CenterPhase 2

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Paragraph IV (Patent) Challenges for TYLENOL
Tradename Dosage Ingredient NDA Submissiondate
TYLENOL TABLET, EXTENDED RELEASE;ORAL acetaminophen 019872

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   Start Trial   Start Trial   Start Trial
Ortho Mcneil Pharm TYLENOL W/ CODEINE acetaminophen; codeine phosphate TABLET;ORAL 085056-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
J And J Consumer Inc TYLENOL acetaminophen TABLET, EXTENDED RELEASE;ORAL 019872-002 Jan 11, 2001 OTC Yes Yes   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 085056-003 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

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

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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Dow
McKesson
McKinsey
Harvard Business School

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