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Last Updated: March 19, 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
Cerovene Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 207574-001 Dec 13, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nesher Pharms OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 210079-002 Dec 28, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vintage Pharms OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040105-001 Jul 30, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nostrum Labs Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 209385-002 Jul 2, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wes Pharma Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 207510-002 Mar 21, 2018 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rhodes Pharms OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201278-003 Aug 28, 2014 AA RX 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
South Korea 20140021992 METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS ⤷  Try a Trial
Canada 2720108 FORMES MEDICAMENTEUSES A LIBERATION ETENDUE DE RETENTION GASTRIQUE COMPRENANT DES COMBINAISONS D'UN ANALGESIQUE NON OPIOIDE ET D'UN ANALGESIQUE OPIOIDE (GASTRIC RETENTIVE EXTENDED-RELEASE DOSAGE FORMS COMPRISING COMBINATIONS OF A NON-OPIOID ANALGESIC AND AN OPIOID ANALGESIC) ⤷  Try a Trial
China 102105136 Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic ⤷  Try a Trial
Russian Federation 2013132138 СПОСОБЫ ПОЛУЧЕНИЯ СТАБИЛИЗИРОВАННОЙ ТВЁРДОЙ ДОЗИРОВАННОЙ ФОРМЫ ФАРМАЦЕВТИЧЕСКИХ КОМПОЗИЦИЙ, СОДЕРЖАЩИХ МОРФИНАНЫ ⤷  Try a Trial
European Patent Office 1439826 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009114648 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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