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Last Updated: June 24, 2022

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, Epic Pharma Llc, Granules, Lannett Co Inc, Mayne Pharma 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-one 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
Albany Medical CollegePhase 4
Bhupesh Parashar, MDPhase 2
University of California, IrvinePhase 4

See all acetaminophen; oxycodone hydrochloride clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing325MG; 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 Class Opioid 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
Vintage Pharms OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride CAPSULE;ORAL 040106-001 Jul 30, 1996 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms TYLOX acetaminophen; oxycodone hydrochloride CAPSULE;ORAL 088790-001 Dec 12, 1984 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lannett Co Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 207333-002 Sep 25, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040545-001 Jun 30, 2004 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride SOLUTION;ORAL 040680-001 Sep 29, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Australia 2009223061 Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic See Plans and Pricing
China 102105136 Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009114648 See Plans and Pricing
Japan 2011513499 See Plans and Pricing
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) See Plans and Pricing
Hong Kong 1152469 GASTRIC RETENTIVE EXTENDED-RELEASE DOSAGE FORMS COMPRISING COMBINATIONS OF A NON-OPIOID ANALGESIC AND AN OPIOID ANALGESIC See Plans and Pricing
World Intellectual Property Organization (WIPO) 2012087377 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Mallinckrodt
Medtronic
Johnson and Johnson
Boehringer Ingelheim

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