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Last Updated: December 13, 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, 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
Ortho Mcneil Pharm TYLOX-325 acetaminophen; oxycodone hydrochloride CAPSULE;ORAL 088246-001 Nov 8, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lannett Co Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 207333-001 Sep 25, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lannett Co Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 207333-002 Sep 25, 2017 DISCN No No ⤷  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
World Intellectual Property Organization (WIPO) 2012087377 ⤷  Sign Up
Japan 5607550 ⤷  Sign Up
Mexico 2010009990 FORMAS DE DOSIFICACIÓN GÁSTRICAS RETENTIVAS DE LIBERACIÓN PROLONGADA QUE COMPRENDEN COMBINACIONES DE UN ANALGÉSICO NO OPIOIDE Y UN ANALGÉSICO OPIOIDE. (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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