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Details for Patent: 9,433,619

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Which drugs does patent 9,433,619 protect, and when does it expire?

Patent 9,433,619 protects ZOHYDRO ER and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 9,433,619

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:	15/154,527
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,433,619
Patent Claim Types: see list of patent claims	Use; Formulation; Device; Composition; Dosage form;

Drugs Protected by US Patent 9,433,619

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

Non-Orange Book US Patents Family Members for Patent 9,433,619

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
9,339,499	Treating pain in patients with hepatic impairment
9,421,201	Treating pain in patients with hepatic impairment
9,522,147	Treating pain in patients with hepatic impairment
9,265,760	Treating pain in patients with hepatic impairment

International Family Members for US Patent 9,433,619

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2872677
World Intellectual Property Organization (WIPO)	2014022570