Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 7, 2019

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 Persion and is included in one NDA. It is available from one supplier. There are sixteen 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. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.
Summary for 202880
Tradename:ZOHYDRO ER
Applicant:Persion
Ingredient:hydrocodone bitartrate
Patents:16
Formulation / Manufacturing:see details
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 Persion Pharmaceuticals LLC 65224-310 65224-310-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65224-310-60)
ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880 NDA Persion Pharmaceuticals LLC 65224-315 65224-315-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65224-315-60)
Paragraph IV (Patent) Challenges for 202880
Tradename Dosage Ingredient NDA Submissiondate
ZOHYDRO ER CAPSULE, EXTENDED RELEASE;ORAL hydrocodone bitartrate 202880 2014-02-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 25, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jul 25, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Patent:  Start TrialPatent Expiration:Sep 12, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN
Patent:  Start TrialPatent Expiration:Jul 25, 2033Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 202880

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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