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Details for Patent: 9,265,760

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Patent 9,265,760 protects ZOHYDRO ER and is included in one NDA. There has been one Paragraph IV challenge on Zohydro ER. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has two patent family members in two countries.

Summary for Patent: 9,265,760

Title:Treating pain in patients with hepatic impairment
Abstract: An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.
Inventor(s): Hartman; Andrew (Belmont, CA), Rubino; Christopher M. (Williamsville, NY), Robinson; Cynthia Y. (Burlingame, CA)
Assignee: Pemix Ireland Pain Limited (Dublin, IE)
Application Number:14/815,219
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form; Device;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 7th percentile
Forward Citations: 1st percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Pernix Ireland Pain
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL202880-001Oct 25, 2013RXYes9,265,760► subscribe TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Pernix Ireland Pain
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL202880-002Oct 25, 2013RXNo9,265,760► subscribe TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Pernix Ireland Pain
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL202880-003Oct 25, 2013RXNo9,265,760► subscribe TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
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Non-Orange Book Patents for Patent: 9,265,760

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
9,326,982Treating pain in patients with hepatic impairment► subscribe
9,339,499Treating pain in patients with hepatic impairment► subscribe
9,421,200Treating pain in patients with hepatic impairment► 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 Patent: 9,265,760

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada2872677► subscribe
World Intellectual Property Organization (WIPO)2014022570► 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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