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Acetaminophen; oxycodone hydrochloride - Generic Drug Details

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Acetaminophen; oxycodone hydrochloride is the generic ingredient in twelve branded drugs marketed by Actavis Elizabeth, Vintage Pharms Llc, Roxane, Barr, Vintage Pharms, Mikart, Bristol Myers Squibb, Mutual Pharm, Mallinckrodt Inc, Watson Labs, Sun Pharm Inds Inc, Mallinckrodt, Ortho Mcneil Pharm, Aurolife Pharma Llc, Duramed Pharms Barr, Alvogen Malta, Amneal Pharms Ny, Mayne Pharma Inc, Rhodes Pharms, Janssen Pharms, and Halsey, and is included in fifty-three NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-three patent family members in nineteen countries.

There are sixty-five drug master file entries for acetaminophen; oxycodone hydrochloride. Forty-four suppliers are listed for this compound.

Summary for Generic Name: acetaminophen; oxycodone hydrochloride

Tradenames:12
Patents:12
Applicants:21
NDAs:53
Drug Master File Entries: see list65
Suppliers / Packaging: see list44
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: acetaminophen; oxycodone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Inc
XARTEMIS XR
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014RXYes8,372,432► subscribeY ► subscribe
Mikart
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL040679-001May 16, 2006DISCNNo► subscribe► subscribe
Vintage Pharms
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL090734-001Jul 11, 2013RXNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: acetaminophen; oxycodone hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,858,963Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► subscribe
9,198,861Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans► subscribe
8,790,694Gastric retentive extended release pharmaceutical compositions► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: acetaminophen; oxycodone hydrochloride

Country Document Number Estimated Expiration
New Zealand523214► subscribe
European Patent Office2262484► subscribe
China103402499► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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