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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for Patent: 10,028,946

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Which drugs does patent 10,028,946 protect, and when does it expire?

Patent 10,028,946 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 10,028,946
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: Pernix Ireland Pain Designated Activity Company (Dublin, IE)
Application Number:15/477,561
Patent Claim Types:
see list of patent claims
Use; Formulation; Device;

Drugs Protected by US Patent 10,028,946

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013 RX Yes Yes   Start Trial   Start Trial TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 RX Yes No   Start Trial   Start Trial TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013 RX Yes No   Start Trial   Start Trial TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-004 Oct 25, 2013 RX Yes No   Start Trial   Start Trial TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-005 Oct 25, 2013 RX Yes No   Start Trial   Start Trial TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 RX Yes No   Start Trial   Start Trial TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,028,946

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2872677   Start Trial
China 103904260   Start Trial
China 105759918   Start Trial
Japan 2014127347   Start Trial
Japan 6089296   Start Trial
World Intellectual Property Organization (WIPO) 2014022570   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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