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ZOHYDRO ER Drug 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 Persion and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-two patent family members in twelve countries.
The generic ingredient in ZOHYDRO ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.
US ANDA 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: | 22 |
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| 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 |
| DailyMed Link: | ZOHYDRO ER at DailyMed |
See drug prices for ZOHYDRO ER
Pharmacology for ZOHYDRO ER
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-005 | Oct 25, 2013 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-003 | Oct 25, 2013 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-002 | Oct 25, 2013 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start 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 |
|---|---|---|---|---|---|---|---|
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-001 | Oct 25, 2013 | Start Trial | Start Trial |
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-005 | Oct 25, 2013 | Start Trial | Start Trial |
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-003 | Oct 25, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZOHYDRO ER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20090024284 | Start Trial |
| Singapore | 11201701845X | Start Trial |
| South Africa | 200810221 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
