DrugPatentWatch Database Preview
ZOHYDRO ER Drug Profile
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Which patents cover Zohydro Er, and when can generic versions of Zohydro Er launch?
This drug has one hundred and fifty-four 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. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.
Summary for ZOHYDRO ER
| International Patents: | 154 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 10 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZOHYDRO ER |
| DailyMed Link: | ZOHYDRO ER at DailyMed |
Generic Entry Opportunity Date for ZOHYDRO ER
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for ZOHYDRO ER
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for ZOHYDRO ER
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pernix Ireland Pain | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-006 | Oct 25, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Pernix Ireland Pain | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-004 | Oct 25, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Pernix Ireland Pain | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-003 | Oct 25, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Pernix Ireland Pain | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-004 | Oct 25, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for ZOHYDRO ER
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for ZOHYDRO ER
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,730,325 | Multiparticulate modified release composition | ➤ Sign Up |
| 7,580,712 | Wireless high-speed data network planning tool | ➤ Sign Up |
| 8,119,163 | Nanoparticulate and controlled release compositions comprising cefditoren | ➤ Sign Up |
| 9,522,147 | Treating pain in patients with hepatic impairment | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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