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 21^st, 2020.

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Summary for ZOHYDRO ER

International Patents:	35
US Patents:	16
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	10
Drug Prices:	Drug price information for ZOHYDRO ER
Drug Sales Revenues:	Drug sales revenues for ZOHYDRO ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOHYDRO ER
What excipients (inactive ingredients) are in ZOHYDRO ER?	ZOHYDRO ER excipients list
DailyMed Link:	ZOHYDRO ER at DailyMed

Drug patent expirations by year for ZOHYDRO ER

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
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

Abuse resistant pharmaceutical compositions
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PAIN

Treating pain in patients with hepatic impairment
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Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

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

Abuse resistant pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

Abuse resistant pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PAIN

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

Abuse resistant pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PAIN

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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	⤷ Sign Up	⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Australia	2012202743		⤷ Sign Up
Croatia	P20210973		⤷ Sign Up
Japan	2009516636		⤷ Sign Up
Australia	2007260822		⤷ Sign Up
Norway	20076588		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for ZOHYDRO ER

Paragraph IV (Patent) Challenges for ZOHYDRO ER

Patents protecting ZOHYDRO ER

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