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Last Updated: February 28, 2024

ZOHYDRO ER Drug Patent Profile


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When do Zohydro Er patents expire, and when can generic versions of Zohydro Er launch?

Zohydro Er 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.

This drug has thirty-five patent family members in twenty-three 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Zohydro Er

A generic version of ZOHYDRO ER was approved as hydrocodone bitartrate by ALVOGEN on January 21st, 2020.

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Paragraph IV (Patent) Challenges for ZOHYDRO ER
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZOHYDRO ER Extended-release Capsules hydrocodone bitartrate 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg 202880 1 2014-02-26

US Patents and Regulatory Information for ZOHYDRO ER

ZOHYDRO ER is protected by sixteen US patents.

Patents protecting ZOHYDRO ER

Treating pain in patients with hepatic impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Abuse resistant pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN

Treating pain in patients with hepatic impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Abuse resistant pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treating pain in patients with hepatic impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Abuse resistant pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN

Abuse resistant pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN

Treating pain in patients with hepatic impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Abuse resistant pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-005 Oct 25, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-004 Oct 25, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-005 Oct 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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