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Last Updated: April 17, 2021

DrugPatentWatch Database Preview

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 Healthcare Ltd, Actavis Mid Atlantic, Akorn, Anda Repository, Dava Pharms Inc, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Valeant Pharms Llc, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Eywa, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vintage Pharms, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, and Janssen Pharms, and is included in one hundred and ten NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; codeine phosphate. Thirty-three suppliers are listed for this compound.

Summary for acetaminophen; codeine phosphate
Recent Clinical Trials for acetaminophen; codeine phosphate

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

SponsorPhase
Roxane LaboratoriesPhase 1

See all acetaminophen; codeine phosphate clinical trials

Pharmacology for acetaminophen; codeine phosphate
Drug ClassOpioid 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
Mutual Pharm ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 085795-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Nostrum Labs Inc ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 088627-001 Mar 6, 1985 AA RX No No   Start Trial   Start Trial   Start Trial
Ortho Mcneil Pharm TYLENOL W/ CODEINE acetaminophen; codeine phosphate TABLET;ORAL 085056-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Eywa ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 211610-003 Jun 27, 2019 AA RX No No   Start Trial   Start Trial   Start Trial
Mikart ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089363-001 Sep 9, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Mid Atlantic CAPITAL AND CODEINE acetaminophen; codeine phosphate SUSPENSION;ORAL 085883-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Anda Repository ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate SOLUTION;ORAL 089450-001 Oct 27, 1992 AA RX 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

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