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Last Updated: November 4, 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 freedom to operate?

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, Endo Operations, Hikma, Mallinckrodt Inc, Bristol Myers Squibb, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell, Dr Reddys Labs Sa, Elite Labs Inc, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sanaluz, 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
Henry Ford Health SystemPhase 4
Jessyka LighthallPhase 3
Universidad Simón BolívarPhase 3

See all ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up325MG; 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
Specgx Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040545-001 Jun 30, 2004 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abhai Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 210644-004 Feb 9, 2018 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 090177-006 Oct 20, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurolife Pharma Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201972-002 Jul 15, 2013 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Epic Pharma Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 203864-003 Jul 2, 2018 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations PERCOCET acetaminophen; oxycodone hydrochloride TABLET;ORAL 040330-001 Jun 25, 1999 AA RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Japan 2014500315 ⤷  Sign Up
Mexico 2013007057 METODOS PARA PRODUCIR COMPOSICIONES FARMACEUTICAS ESTABILIZADAS DE DOSIS SOLIDA QUE CONTIENEN MORFINANOS. (METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS.) ⤷  Sign Up
European Patent Office 2262484 FORMES MÉDICAMENTEUSES À LIBÉRATION ÉTENDUE DE RÉTENTION GASTRIQUE COMPRENANT DES COMBINAISONS D'UN ANALGÉSIQUE NON OPIOÏDE ET D'UN ANALGÉSIQUE OPIOÏDE (GASTRIC RETENTIVE EXTENDED-RELEASE DOSAGE FORMS COMPRISING COMBINATIONS OF A NON-OPIOID ANALGESIC AND AN OPIOID ANALGESIC) ⤷  Sign Up
China 103402499 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans ⤷  Sign Up
South Korea 101748906 ⤷  Sign Up
Australia 2009223061 Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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