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Last Updated: May 10, 2021

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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 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 Pharms, Lannett Co Inc, Mayne Pharma Inc, Mikart, Nesher Pharms, Nostrum Labs Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in sixty-five 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 patent family members in thirteen countries.

There are sixty-six drug master file entries for acetaminophen; oxycodone hydrochloride. Thirty suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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

SponsorPhase
University of OklahomaEarly Phase 1
NYU Langone HealthPhase 4
State University of New York at BuffaloPhase 3

See all ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $10325MG; 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

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
Alvogen OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 202677-003 Mar 8, 2016 AA RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Duramed Pharms Barr OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040272-001 Jun 30, 1998 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Ortho Mcneil Pharm TYLOX-325 acetaminophen; oxycodone hydrochloride CAPSULE;ORAL 088246-001 Nov 8, 1984 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Novel Labs Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 204407-003 Feb 24, 2017 AA RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Vintage Pharms Llc PERCOCET acetaminophen; oxycodone hydrochloride TABLET;ORAL 040330-004 Nov 23, 2001 AA RX No Yes   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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