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Last Updated: November 12, 2019

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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, West-ward Pharms Int, Mallinckrodt Inc, Bristol Myers Squibb, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Epic Pharma Llc, Halo Pharm Canada, Lannett Co Inc, Mayne Pharma Inc, Mikart, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sun Pharm Inds Inc, Wes Pharma Inc, and Xiromed, and is included in sixty-four 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-eight patent family members in nineteen countries.

There are sixty-six drug master file entries for acetaminophen; oxycodone hydrochloride. Forty-three 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

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SponsorPhase
Northwestern UniversityPhase 4
Dean EltermanPhase 4
University of UtahPhase 4

See all acetaminophen; oxycodone hydrochloride clinical trials

Recent Litigation for acetaminophen; oxycodone hydrochloride

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District Court Litigation
Case NameDate
MALLINCKRODT LLC v. WATSON LABORATORIES, INC.- FLORIDA2015-06-05
Depomed Inc. v. Watson Laboratories Inc. - Florida2013-02-28
Purdue Pharma LP v. Sandoz Inc.2012-10-10

See all acetaminophen; oxycodone hydrochloride litigation

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
Watson Labs OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride CAPSULE;ORAL 040234-001 Oct 30, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201447-004 Apr 12, 2013 AA RX No No   Start Trial   Start Trial   Start Trial
Mayne Pharma Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 090177-006 Oct 20, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Janssen Pharms TYLOX acetaminophen; oxycodone hydrochloride CAPSULE;ORAL 088790-001 Dec 12, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Mikart OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040608-002 Dec 30, 2005 RX No Yes   Start Trial   Start Trial   Start Trial
Vintage Pharms Llc PERCOCET acetaminophen; oxycodone hydrochloride TABLET;ORAL 040330-001 Jun 25, 1999 AA RX No Yes   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
>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

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