Details for Patent: 9,265,760
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Which drugs does patent 9,265,760 protect, and when does it expire?
Patent 9,265,760 protects ZOHYDRO ER and is included in one NDA.
This patent has six patent family members in four 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 Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 9,265,760 |
Patent Claim Types: see list of patent claims | Use; Formulation; Dosage form; Device; |
Drugs Protected by US Patent 9,265,760
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-001 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT | ⤷ Sign Up | ||||
Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-002 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT | ⤷ Sign Up | ||||
Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-003 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT | ⤷ Sign Up | ||||
>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 9,265,760
Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
---|---|---|---|---|---|
Canada | 2872677 | ⤷ Sign Up | |||
China | 103904260 | ⤷ Sign Up | |||
China | 105759918 | ⤷ Sign Up | |||
>Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |