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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
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Medtronic
Merck
UBS
Mallinckrodt
Julphar
Harvard Business School
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Generated: July 20, 2017

DrugPatentWatch Database Preview

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, Vintage Pharms Llc, West-ward Pharms Int, Barr, Vintage Pharms, Novel Labs Inc, Mikart, Bristol Myers Squibb, Mutual Pharm, Ascent Pharms Inc, Mallinckrodt Inc, Watson Labs, Sun Pharm Inds Inc, Mallinckrodt, Ortho Mcneil Pharm, Roxane, Aurolife Pharma Llc, Duramed Pharms Barr, Cerovene Inc, Alvogen Malta, Amneal Pharms, Mayne Pharma Inc, Amneal Pharms Ny, Rhodes Pharms, Janssen Pharms, and Halsey, and is included in fifty-five NDAs. There are fourteen 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-five patent family members in nineteen countries.

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

Summary for Generic Name: acetaminophen; oxycodone hydrochloride

Tradenames:12
Patents:14
Applicants:26
NDAs:55
Drug Master File Entries: see list66
Suppliers / Packagers: see list49
Clinical Trials: see list3,083
Drug Prices:see low prices
DailyMed Link:acetaminophen; oxycodone hydrochloride at DailyMed

Pharmacology for Ingredient: 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 Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL040203-001Mar 15, 1999DISCNNoNo► Subscribe► Subscribe
Sun Pharm Inds Inc
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL090535-001Dec 26, 2013AARXNoNo► Subscribe► Subscribe
Mallinckrodt
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL040545-001Jun 30, 2004AARXNoNo► Subscribe► Subscribe
Ortho Mcneil Pharm
TYLOX-325
acetaminophen; oxycodone hydrochloride
CAPSULE;ORAL088246-001Nov 8, 1984DISCNNoNo► Subscribe► Subscribe
Ascent Pharms Inc
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL207419-001Mar 22, 2017AARXNoNo► 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
9,629,837Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia► Subscribe
8,790,694Gastric retentive extended release pharmaceutical compositions► Subscribe
9,198,861Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans► Subscribe
9,433,582Gastric retentive extended release pharmaceutical compositions► Subscribe
9,539,328Tamper 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
Canada2412671► Subscribe
Portugal1294363► Subscribe
New Zealand523214► Subscribe
World Intellectual Property Organization (WIPO)0197783► Subscribe
Japan2009040787► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Healthtrust
Cantor Fitzgerald
Baxter
Accenture
Argus Health
Julphar
Farmers Insurance
Chubb
AstraZeneca
Moodys

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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