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Generated: July 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202880

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NDA 202880 describes ZOHYDRO ER, which is a drug marketed by Pernix Ireland Pain and is included in one NDA. It is available from two suppliers. There are thirteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZOHYDRO ER profile page.

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.
Summary for 202880
Tradename:ZOHYDRO ER
Applicant:Pernix Ireland Pain
Ingredient:hydrocodone bitartrate
Patents:13
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 202880
Generic Entry Date for 202880*:
Constraining patent/regulatory exclusivity:
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 NDA: 202880
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for 202880
Suppliers and Packaging for NDA: 202880
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880 NDA Zogenix, Inc. 43376-210 E 43376-210-10
ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880 NDA Zogenix, Inc. 43376-215 E 43376-215-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 25, 2013TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Sep 12, 2034Product Flag?YSubstance Flag?Delist Request?

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