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ZOHYDRO ER Drug Profile

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Zohydro Er is a drug marketed by Pernix Ireland Pain and is included in one NDA. It is available from two suppliers. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-one patent family members in thirty-two countries.

The generic ingredient in ZOHYDRO ER is hydrocodone bitartrate. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the hydrocodone bitartrate profile page.

Summary for Tradename: ZOHYDRO ER

Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: ZOHYDRO ER

Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pernix Ireland Pain
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL202880-004Oct 25, 2013RXNo6,902,742► subscribeY ► subscribe
Pernix Ireland Pain
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL202880-003Oct 25, 2013RXNo9,132,096► subscribeY ► subscribe
Pernix Ireland Pain
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL202880-005Oct 25, 2013RXNo9,339,499► subscribe ► subscribe
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Paragraph IV activity for: ZOHYDRO ER

Drugname Dosage Strength RLD Submissiondate
hydrocodone bitartrateExtended-release Capsules10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mgZohydro ER2/26/2014

Non-Orange Book Patents for Tradename: 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► subscribe
9,421,201Treating pain in patients with hepatic impairment► subscribe
8,119,163Nanoparticulate and controlled release compositions comprising cefditoren► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ZOHYDRO ER

Country Document Number Estimated Expiration
Czech Republic20011539► subscribe
Canada2611938► subscribe
Japan2002528485► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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.

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