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Last Updated: September 25, 2022

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. 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 No. 4

A generic version of TYLENOL W/ CODEINE NO. 4 was approved as acetaminophen; codeine phosphate by SUN PHARM INDS LTD on December 31st, 1969.

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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
Humber River HospitalPhase 4
Blake RaggioPhase 4

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Pharmacology for TYLENOL W/ CODEINE NO. 4
Drug Class Opioid Agonist
Mechanism of ActionFull Opioid Agonists

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms TYLENOL W/ CODEINE NO. 4 acetaminophen; codeine phosphate TABLET;ORAL 085055-004 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.