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Last Updated: September 21, 2021

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 Recro Gainesville and is included in one NDA. 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:Recro Gainesville
Ingredient:hydrocodone bitartrate
Patents:16
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202880
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:ABRLD:Yes
Patent:⤷  Try it FreePatent Expiration:Jul 25, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Patent:⤷  Try it FreePatent Expiration:Sep 12, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN
Patent:⤷  Try it FreePatent 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
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 ⤷  Try it Free ⤷  Try it Free
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013 ⤷  Try it Free ⤷  Try it Free
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-005 Oct 25, 2013 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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