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Last Updated: May 24, 2022

ACETAMINOPHEN; CODEINE PHOSPHATE - Generic Drug Details


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What are the generic sources for acetaminophen; codeine phosphate and what is the scope of patent protection?

Acetaminophen; codeine phosphate is the generic ingredient in seventeen branded drugs marketed by Teva, Robins Ah, Solvay, Ortho Mcneil Pharm, ACI, Actavis Mid Atlantic, Akorn, Dava Pharms Inc, Lannett Co Inc, Mikart, Pharm Assoc, Wockhardt Bio Ag, Valeant Pharms Llc, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Chartwell, Duramed Pharms Barr, Elite Labs Inc, Everylife, Eywa, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, and Janssen Pharms, and is included in one hundred and eight NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-two suppliers are listed for this compound.

Summary for ACETAMINOPHEN; CODEINE PHOSPHATE
Recent Clinical Trials for ACETAMINOPHEN; CODEINE PHOSPHATE

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SponsorPhase
Roxane LaboratoriesPhase 1

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Pharmacology for ACETAMINOPHEN; CODEINE PHOSPHATE
Drug Class Opioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for ACETAMINOPHEN; CODEINE PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Usl Pharma ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 087919-001 Jun 22, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Warner Chilcott ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 085992-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eywa ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 211610-003 Jun 27, 2019 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Able ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 040452-001 Aug 1, 2002 DISCN No 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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