Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
AstraZeneca
Moodys
Mallinckrodt
Medtronic

Last Updated: January 28, 2020

DrugPatentWatch Database Preview

ZOHYDRO ER Drug Profile

See Plans and Pricing

« Back to Dashboard

Which patents cover Zohydro Er, and when can generic versions of Zohydro Er launch?

Zohydro Er is a drug marketed by Persion and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty patent family members in thirty-four countries.

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.

US ANDA Litigation and Generic Entry Outlook for Zohydro Er

Zohydro Er was eligible for patent challenges on December 31, 1968.

There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (hydrocodone bitartrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Drug patent expirations by year for ZOHYDRO ER
Drug Prices for ZOHYDRO ER

See drug prices for ZOHYDRO ER

Drug Sales Revenue Trends for ZOHYDRO ER

See drug sales revenues for ZOHYDRO ER

Recent Litigation for ZOHYDRO ER

Identify potential future generic entrants

District Court Litigation
Case NameDate
Recro Gainesville LLC v. Actavis Laboratories FL, Inc.2017-10-30
Pernix Ireland Pain Ltd. v. Actavis Laboratories FL, Inc.2016-03-04
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15

See all ZOHYDRO ER litigation

Pharmacology for ZOHYDRO ER
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Paragraph IV (Patent) Challenges for ZOHYDRO ER
Tradename Dosage Ingredient NDA Submissiondate
ZOHYDRO ER CAPSULE, EXTENDED RELEASE;ORAL hydrocodone bitartrate 202880 2014-02-26

US Patents and Regulatory Information for ZOHYDRO ER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-005 Oct 25, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZOHYDRO ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 202880-001 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
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-004 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 202880-002 Oct 25, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Express Scripts
Harvard Business School
McKinsey
AstraZeneca

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.