Last Updated: September 24, 2026

Details for New Drug Application (NDA): 202880

✉ Email this page to a colleague

NDA 202880 describes ZOHYDRO ER, which 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. Additional details are available on the ZOHYDRO ER profile page.

The generic ingredient in ZOHYDRO ER is hydrocodone bitartrate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.

Summary for 202880

Tradename:	ZOHYDRO ER
Applicant:	Recro Gainesville
Ingredient:	hydrocodone bitartrate
Patents:	16

Medical Subject Heading (MeSH) Categories for 202880

Analgesics, Opioid
Antitussive Agents
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Oct 25, 2013	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Jul 25, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Patent:	⤷ Start Trial	Patent Expiration:	Sep 12, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PAIN
Patent:	⤷ Start Trial	Patent Expiration:	Jul 25, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202880

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013	⤷ Start Trial	⤷ Start Trial
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013	⤷ Start Trial	⤷ Start Trial
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013	⤷ Start Trial	⤷ Start Trial
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

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

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.