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Last Updated: February 23, 2024

TYLENOL W/ CODEINE NO. 4 Drug Patent Profile


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When do Tylenol W/ Codeine No. 4 patents expire, and what generic alternatives are available?

Tylenol W/ Codeine No. 4 is a drug marketed by Ortho Mcneil Pharm and Janssen Pharms and is included in two NDAs.

The generic ingredient in TYLENOL W/ CODEINE NO. 4 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tylenol W/ Codeine No. 4

A generic version of TYLENOL W/ CODEINE NO. 4 was approved as acetaminophen; codeine phosphate by WES PHARMA INC on June 27th, 2019.

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Drug patent expirations by year for TYLENOL W/ CODEINE NO. 4
Recent Clinical Trials for TYLENOL W/ CODEINE NO. 4

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SponsorPhase
Eurofarma Laboratorios S.A.Phase 3
University of TorontoPhase 4
Humber River HospitalPhase 4

See all TYLENOL W/ CODEINE NO. 4 clinical trials

US Patents and Regulatory Information for TYLENOL W/ CODEINE NO. 4

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 NO. 4 acetaminophen; codeine phosphate CAPSULE;ORAL 087421-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TYLENOL W/ CODEINE NO. 4 acetaminophen; codeine phosphate TABLET;ORAL 085055-004 Approved Prior to Jan 1, 1982 DISCN Yes 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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