Make Better Decisions

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Queensland Health
Cantor Fitzgerald
Novartis
Chinese Patent Office
US Army
Teva
McKesson
Boehringer Ingelheim
Dow

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for Patent: 9,433,619

« Back to Dashboard

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 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 ➤ Subscribe ➤ Subscribe TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ➤ Subscribe
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ➤ Subscribe
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ➤ Subscribe
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-004 Oct 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ➤ Subscribe
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-005 Oct 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ➤ Subscribe
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ➤ Subscribe
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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

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
9,265,760 Treating pain in patients with hepatic impairment ➤ Subscribe
9,522,147 Treating pain in patients with hepatic impairment ➤ Subscribe
9,421,200 Treating pain in patients with hepatic impairment ➤ Subscribe
9,421,201 Treating pain in patients with hepatic impairment ➤ Subscribe
9,326,982 Treating pain in patients with hepatic impairment ➤ Subscribe
9,333,201 Treating pain in patients with hepatic impairment ➤ Subscribe
9,339,499 Treating pain in patients with hepatic impairment ➤ Subscribe
9,610,286 Treating pain in patients with hepatic impairment ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Deloitte
Federal Trade Commission
Fuji
Express Scripts
McKinsey
US Department of Justice
Daiichi Sankyo
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot