DrugPatentWatch Database Preview
ZOHYDRO ER Drug Profile
Which patents cover Zohydro Er, 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 seventeen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixty patent family members in thirty-four 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.
US ANDA Litigation and Generic Entry Outlook for Zohydro Er
Zohydro Er was eligible for patent challenges on December 31, 1968.
There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are two tentative approvals for the generic drug (hydrocodone bitartrate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for ZOHYDRO ER
| International Patents: | 160 |
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| 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 |
| DailyMed Link: | ZOHYDRO ER at DailyMed |
See drug prices for ZOHYDRO ER
Recent Litigation for ZOHYDRO ER
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Recro Gainesville LLC v. Actavis Laboratories FL, Inc. | 2017-10-30 |
| Pernix Ireland Pain Ltd. v. Actavis Laboratories FL, Inc. | 2016-03-04 |
| Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-15 |
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 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-006 | Oct 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-003 | Oct 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-002 | Oct 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-006 | Oct 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-003 | Oct 25, 2013 | 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 | 202880-006 | Oct 25, 2013 | Start Trial | Start Trial |
| 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 | 202880-003 | Oct 25, 2013 | Start Trial | Start Trial |
| Persion | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-004 | 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 | 202880-002 | 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 |
|---|---|---|
| European Patent Office | 2311442 | Start Trial |
| European Patent Office | 1905432 | Start Trial |
| Hong Kong | 1117060 | Start Trial |
| Russian Federation | 2017112301 | Start Trial |
| Poland | 348633 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006132752 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
