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Acetaminophen; oxycodone hydrochlorideis 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
|Drug Master File Entries:||66|
|Suppliers / Packagers:||30|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for acetaminophen; oxycodone hydrochloride|
|DailyMed Link:||acetaminophen; oxycodone hydrochloride at DailyMed|
Recent Clinical Trials for acetaminophen; oxycodone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|University of Oklahoma||Early Phase 1|
|NYU Langone Health||Phase 4|
|State University of New York at Buffalo||Phase 3|
Generic filers with tentative approvals for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
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 Action||Full Opioid Agonists |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Mallinckrodt Inc||XARTEMIS XR||acetaminophen; oxycodone hydrochloride||TABLET, EXTENDED RELEASE;ORAL||204031-001||Mar 11, 2014||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
|Country||Patent Number||Estimated Expiration|
|South Korea||20030023876||Start Trial|
|European Patent Office||2262484||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|
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