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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
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

International Family Members for US Patent 10,028,946

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2872677
China	103904260
China	105759918
Japan	2014127347