Zohydro ER Drug Patent Profile
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When do Zohydro Er patents expire, and what generic alternatives are available?
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.
Summary for Zohydro ER
International Patents: | 35 |
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 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Abuse resistant pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN
Treating pain in patients with hepatic impairment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Treating pain in patients with hepatic impairment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Abuse resistant pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Treating pain in patients with hepatic impairment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Treating pain in patients with hepatic impairment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Treating pain in patients with hepatic impairment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Treating pain in patients with hepatic impairment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Treating pain in patients with hepatic impairment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Treating pain in patients with hepatic impairment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Abuse resistant pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN
Abuse resistant pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN
Treating pain in patients with hepatic impairment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Abuse resistant pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-003 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-002 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 | 202880-003 | Oct 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-003 | Oct 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-004 | Oct 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Eurasian Patent Organization | 200701195 | ⤷ Try a Trial | |
Israel | 196065 | ⤷ Try a Trial | |
China | 100444830 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |