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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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 |
See drug prices 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
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
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
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
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
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
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
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
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
| 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 | ||||
| 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
| 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 | 202880-004 | 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 |
| Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-002 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-005 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-002 | 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2008540550 | ⤷ Sign Up | |
| Japan | 2010270128 | MULTIPARTICULATE MODIFIED RELEASE COMPOSITION | ⤷ Sign Up |
| Mexico | 2007007942 | COMPOSICIONES DE MATERIAL NANOPARTICULADO Y DE LIBERACION CONTROLADA QUE COMPRENDEN UNA CEFALOSPORINA. (NANOPARTICULATE AND CONTROLLED RELEASE COMPOSITIONS COMPRISING A CEPHALOSPORIN.) | ⤷ Sign Up |
| Israel | 196065 | ⤷ Sign Up | |
| New Zealand | 511442 | Multiparticulate modified release composition for multiple dosing of ADD patients with methylphenidate HCl | ⤷ Sign Up |
| China | 1335768 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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. 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.
ISSN: 2162-2639
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