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Serving leading biopharmaceutical companies globally:

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Generated: December 12, 2017

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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 acetaminophen; oxycodone hydrochloride 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, Mallinckrodt Inc, West-ward Pharms Int, Bristol Myers Squibb, Alvogen Malta, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Cerovene Inc, Lannett Holdings Inc, Mayne Pharma Inc, Mikart, Novel Labs Inc, Rhodes Pharms, and Sun Pharm Inds Inc, and is included in fifty-six 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. Fifty-one suppliers are listed for this compound.

Summary for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Pharmacology for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Ascent Pharms IncOXYCODONE AND ACETAMINOPHENacetaminophen; oxycodone hydrochlorideTABLET;ORAL207419-004Mar 22, 2017AARXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsOXYCODONE AND ACETAMINOPHENacetaminophen; oxycodone hydrochlorideTABLET;ORAL040535-001Sep 5, 2003AARXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mutual PharmOXYCODONE AND ACETAMINOPHENacetaminophen; oxycodone hydrochlorideCAPSULE;ORAL040219-001Jan 22, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
West-ward Pharms IntROXICETacetaminophen; oxycodone hydrochlorideTABLET;ORAL087003-001Approved Prior to Jan 1, 1982AARXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Amneal Pharms NyOXYCODONE AND ACETAMINOPHENacetaminophen; oxycodone hydrochlorideTABLET;ORAL040789-001Nov 27, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MikartOXYCODONE AND ACETAMINOPHENacetaminophen; oxycodone hydrochlorideTABLET;ORAL040698-001Apr 27, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurolife Pharma LlcOXYCODONE AND ACETAMINOPHENacetaminophen; oxycodone hydrochlorideTABLET;ORAL201972-004Jul 15, 2013AARXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis ElizabethOXYCODONE AND ACETAMINOPHENacetaminophen; oxycodone hydrochlorideTABLET;ORAL040203-001Mar 15, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
BarrOXYCODONE AND ACETAMINOPHENacetaminophen; oxycodone hydrochlorideCAPSULE;ORAL040304-001Oct 2, 2000DISCNNoNo► Subscribe► Subscribe► 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
8,790,694Gastric retentive extended release pharmaceutical compositions► Subscribe
9,539,328Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► Subscribe
9,629,837Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia► Subscribe
9,198,861Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans► Subscribe
9,433,582Gastric retentive extended release pharmaceutical compositions► Subscribe
8,858,963Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► 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
Germany60101581► Subscribe
World Intellectual Property Organization (WIPO)0197783► Subscribe
South Korea101748906► Subscribe
China102105136► Subscribe
Australia2001239893► Subscribe
Russian Federation2013132138► Subscribe
TaiwanI324075► Subscribe
European Patent Office1294363► Subscribe
MexicoPA04003930► Subscribe
Australia3989301► 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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Serving leading biopharmaceutical companies globally:

Teva
Moodys
Merck
Boehringer Ingelheim
Chubb
US Department of Justice
UBS
Daiichi Sankyo
Chinese Patent Office
Cerilliant

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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