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Last Updated: April 17, 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 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 Inc, Specgx Llc, Hikma, Mallinckrodt Inc, Bristol Myers Squibb, Alvogen, Amneal Pharms, Amneal Pharms Ny, Anda Repository, Ascent Pharms Inc, Aurolife Pharma Llc, Cerovene Inc, 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 thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetaminophen; oxycodone hydrochloride has forty-nine patent family members in twenty 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.

Summary for acetaminophen; oxycodone hydrochloride
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
  Start Trial  Start 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

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
Aurolife Pharma Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201972-001 Jul 15, 2013 AA RX No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201972-004 Jul 15, 2013 AA RX No No   Start Trial   Start Trial   Start Trial
Vintage Pharms Llc PERCOCET acetaminophen; oxycodone hydrochloride TABLET;ORAL 085106-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Alvogen OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 202677-003 Mar 8, 2016 AA RX No No   Start Trial   Start Trial   Start Trial
Ascent Pharms Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 207419-004 Mar 22, 2017 AA RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

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