➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
AstraZeneca
Express Scripts
Harvard Business School
Dow

Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202880


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 fifteen 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:Persion
Ingredient:hydrocodone bitartrate
Patents:15
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:ABRLD: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 202880-005 Oct 25, 2013   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Johnson and Johnson
Mallinckrodt
Baxter
Harvard Business School

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 verification 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.