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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Teva
US Department of Justice
Cerilliant
Deloitte
McKinsey
Dow
Mallinckrodt
Julphar

Generated: July 18, 2018

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, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Roxane, Janssen Pharms, Ortho Mcneil Pharm, Specgx Llc, West-ward Pharms Int, Mallinckrodt Inc, Bristol Myers Squibb, Abhai Llc, Alvogen Malta, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chemo Research Sl, Elite Labs Inc, Epic Pharma Llc, Lannett Co Inc, Mayne Pharma Inc, Mikart, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in sixty-one 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-four suppliers are listed for this compound.
Summary for acetaminophen; oxycodone hydrochloride
Pharmacology for acetaminophen; oxycodone hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for acetaminophen; oxycodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Vintage Pharms Llc PERCOCET acetaminophen; oxycodone hydrochloride TABLET;ORAL 040330-003 Nov 23, 2001 AA RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurolife Pharma Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201972-001 Jul 15, 2013 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Barr OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 087406-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,790,694 Gastric retentive extended release pharmaceutical compositions ➤ Try a Free Trial
8,858,963 Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia ➤ Try a Free Trial
9,433,582 Gastric retentive extended release pharmaceutical compositions ➤ Try a Free Trial
9,539,328 Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Boehringer Ingelheim
US Army
Julphar
Dow
Cantor Fitzgerald
Cerilliant
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.