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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
McKesson
Accenture
US Department of Justice
Cipla
Healthtrust
Mallinckrodt
Chubb
Harvard Business School

Generated: July 17, 2018

DrugPatentWatch Database Preview

ZOHYDRO ER Drug Profile

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Which patents cover Zohydro Er, and when can generic versions of Zohydro Er launch?

Zohydro Er is a drug marketed by Pernix Ireland Pain and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-four patent family members in thirty-four countries.

The generic ingredient in ZOHYDRO ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.
Drug patent expirations by year for ZOHYDRO ER
Generic Entry Opportunity Date for ZOHYDRO ER
Generic Entry Date for ZOHYDRO ER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ZOHYDRO ER
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for ZOHYDRO ER

US Patents and Regulatory Information for ZOHYDRO ER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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 ➤ 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 ➤ 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 Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for ZOHYDRO ER
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Capsules 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for ZOHYDRO ER

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
6,730,325 Multiparticulate modified release composition ➤ Sign Up
7,580,712 Wireless high-speed data network planning tool ➤ Sign Up
8,119,163 Nanoparticulate and controlled release compositions comprising cefditoren ➤ Sign Up
9,522,147 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:

Cipla
Harvard Business School
Accenture
Johnson and Johnson
Baxter
US Army
Daiichi Sankyo
McKesson
Dow

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.