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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, 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
|Finished Product Suppliers / Packagers:||31|
|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
|Albany Medical College||Phase 4|
|Bhupesh Parashar, MD||Phase 2|
|University of California, Irvine||Phase 4|
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 |
Anatomical Therapeutic Chemical (ATC) Classes for acetaminophen; oxycodone hydrochloride
|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||See Plans and Pricing||See Plans and Pricing|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
|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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