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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
UBS
Chubb
Healthtrust
Boehringer Ingelheim
Harvard Business School
McKesson
QuintilesIMS
Express Scripts

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for Patent: 9,333,201

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Which drugs does patent 9,333,201 protect, and when does it expire?

Patent 9,333,201 protects ZOHYDRO ER and is included in one NDA.

This patent has two patent family members in two countries.
Summary for Patent: 9,333,201
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 Limited (Dublin, IE)
Application Number:14/978,302
Patent Claim Types:
see list of patent claims
Use; Formulation; Device;

Drugs Protected by US Patent 9,333,201

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 ➤ Sign Up ➤ Sign Up TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ➤ Sign Up
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ➤ Sign Up
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ➤ Sign Up
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-004 Oct 25, 2013 RX 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 Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 9,333,201

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
9,522,147 Treating pain in patients with hepatic impairment ➤ Sign Up
9,339,499 Treating pain in patients with hepatic impairment ➤ Sign Up
9,421,200 Treating pain in patients with hepatic impairment ➤ Sign Up
9,265,760 Treating pain in patients with hepatic impairment ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health
Express Scripts
Chinese Patent Office
Merck
Baxter
US Department of Justice
McKesson
Citi

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