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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-two 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 21^st, 2020.

Summary for ZOHYDRO ER

International Patents:	32
US Patents:	16
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	10
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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

See drug prices for ZOHYDRO ER

See drug sales revenues for ZOHYDRO ER

Anatomical Therapeutic Chemical (ATC) Classes for ZOHYDRO ER

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

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

ZOHYDRO ER is protected by sixteen US patents.

Patents protecting ZOHYDRO ER

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

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
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013

International Patents for ZOHYDRO ER

Country	Patent Number	Estimated Expiration
Hungary	E054778
New Zealand	511442
China	101287451
South Africa	200710715
Poland	348633
World Intellectual Property Organization (WIPO)	2008030209
Brazil	PI0705488