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Last Updated: March 30, 2020

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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, Anda Repository, Dava Pharms Inc, Hi Tech Pharma, 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, 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-eight 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

See all acetaminophen; codeine phosphate clinical trials

Synonyms for acetaminophen; codeine phosphate
C18H21NO3.C8H9NO2.H3O4P
Co-codamol
LS-178487
Q4357608
SCHEMBL218798

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 087920-001 Jun 22, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 202800-003 Apr 15, 2013 AA RX No No   Start Trial   Start Trial   Start Trial
Able ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 040459-001 Aug 1, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Hi Tech Pharma ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate SOLUTION;ORAL 040119-001 Apr 26, 1996 AA RX No No   Start Trial   Start Trial   Start Trial
Aci Healthcare Ltd ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate SOLUTION;ORAL 086366-001 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

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Serving leading biopharmaceutical companies globally:

Dow
McKinsey
Colorcon
McKesson
Johnson and Johnson
Medtronic

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