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Last Updated: March 27, 2023

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-three patent family members in twenty-one 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Abuse resistant pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN

Treating pain in patients with hepatic impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Abuse resistant pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treating pain in patients with hepatic impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Treating pain in patients with hepatic impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Abuse resistant pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN

Abuse resistant pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN

Treating pain in patients with hepatic impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Abuse resistant pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-004 Oct 25, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 202880-002 Oct 25, 2013 See Plans and Pricing See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013 See Plans and Pricing See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013 See Plans and Pricing See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-004 Oct 25, 2013 See Plans and Pricing See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ZOHYDRO ER

See the table below for patents covering ZOHYDRO ER around the world.

Country Patent Number Title Estimated Expiration
Spain 2313797 See Plans and Pricing
Brazil 9914977 Composição multiparticulada de liberação modificada See Plans and Pricing
European Patent Office 2032139 See Plans and Pricing
Poland 348633 See Plans and Pricing
Japan 2014127347 ELECTRONIC APPARATUS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Medtronic
Express Scripts
Merck
Moodys

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.