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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
Medtronic
Federal Trade Commission
Queensland Health
US Army
Chubb
Daiichi Sankyo
Covington

Generated: May 26, 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
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 Submissiondate
➤ Subscribe Extended-release Capsules 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg ➤ Subscribe 2014-02-26

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
7,580,712 Wireless high-speed data network planning tool ➤ Sign Up
6,730,325 Multiparticulate modified release composition ➤ Sign Up
8,119,163 Nanoparticulate and controlled release compositions comprising cefditoren ➤ Sign Up
9,421,201 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
Johnson and Johnson
Boehringer Ingelheim
Colorcon
QuintilesIMS
Merck
Deloitte
Citi
Argus Health

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.