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Last Updated: April 17, 2024

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, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Wockhardt Bio Ag, Valeant Pharms Llc, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, 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, Wes Pharma Inc, 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.

Twenty-nine 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

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
Am Therap ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089483-001 Mar 3, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurolife Pharma Llc ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 202800-001 Apr 15, 2013 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Superpharm ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089253-001 May 19, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Robins Ah PHENAPHEN W/ CODEINE NO. 2 acetaminophen; codeine phosphate CAPSULE;ORAL 084444-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Ltd ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 087083-001 Approved Prior to Jan 1, 1982 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ortho Mcneil Pharm TYLENOL W/ CODEINE acetaminophen; codeine phosphate TABLET;ORAL 085056-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 085291-002 Approved Prior to Jan 1, 1982 DISCN No 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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