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Serving leading biopharmaceutical companies globally:

Merck
US Department of Justice
Moodys
Dow
Deloitte
Boehringer Ingelheim
Teva
Argus Health
Cipla
Johnson and Johnson

Generated: February 25, 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, Lannett Holdings Inc, Mayne Pharma Inc, Mikart, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, and Sun Pharm Inds Inc, and is included in fifty-eight 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
International Patents:48
US Patents:13
Tradenames:12
Applicants:30
NDAs:58
Drug Master File Entries: 66
Suppliers / Packagers: 51
Clinical Trials: 970
Drug Prices:see low prices
DailyMed Link:ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE at DailyMed
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
Mayne Pharma Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 090177-005 Oct 20, 2008 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vintage Pharms OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 090734-002 Jul 11, 2013 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms TYLOX acetaminophen; oxycodone hydrochloride CAPSULE;ORAL 088790-001 Dec 12, 1984 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vintage Pharms Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride CAPSULE;ORAL 040303-001 Dec 30, 1999 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mikart OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040692-001 Apr 27, 2006 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novel Labs Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 204407-003 Feb 24, 2017 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abhai Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 210644-002 Feb 9, 2018 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 ➤ Sign Up
9,539,328 Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia ➤ Sign Up
9,629,837 Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia ➤ Sign Up
9,198,861 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans ➤ Sign Up
8,858,963 Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia ➤ Sign Up
9,433,582 Gastric retentive extended release pharmaceutical compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Merck
Fuji
Express Scripts
AstraZeneca
Daiichi Sankyo
Dow
Chinese Patent Office
Julphar

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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