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Last Updated: March 3, 2024

Acetaminophen; oxycodone hydrochloride - Generic Drug Details


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What are the generic drug sources for acetaminophen; oxycodone hydrochloride and what is the scope of patent protection?

Acetaminophen; oxycodone hydrochloride is the generic ingredient in twelve branded drugs marketed by Actavis Elizabeth, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Roxane, Janssen Pharms, Ortho Mcneil Pharm, Abhai Llc, Mikart, Nostrum Labs Inc, Specgx Llc, Hikma, Mallinckrodt Inc, Bristol Myers Squibb, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Cerovene Inc, Chartwell, Dr Reddys Labs Sa, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in sixty-six NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetaminophen; oxycodone hydrochloride has thirty-one patent family members in thirteen countries.

Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for acetaminophen; oxycodone hydrochloride
Recent Clinical Trials for acetaminophen; oxycodone hydrochloride

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

SponsorPhase
Ciusss de L'Est de l'Île de MontréalN/A
Lee A. KralPhase 4
University of TennesseePhase 4

See all acetaminophen; oxycodone hydrochloride clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial325MG; 7.5MGTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for acetaminophen; oxycodone hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Anatomical Therapeutic Chemical (ATC) Classes for acetaminophen; oxycodone hydrochloride

US Patents and Regulatory Information for acetaminophen; oxycodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nostrum Labs Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 209385-003 Jul 2, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040371-001 Dec 29, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mutual Pharm OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride CAPSULE;ORAL 040219-001 Jan 22, 1998 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

International Patents for acetaminophen; oxycodone hydrochloride

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 03035041 ⤷  Try a Trial
Canada 2822553 PROCEDES DE PRODUCTION DE COMPOSITIONS PHARMACEUTIQUES DOSIFIEES SOLIDES STABILISEES CONTENANT DES MORPHINANES (METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS) ⤷  Try a Trial
European Patent Office 1439826 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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