Zohydro Er is a drug owned by Recro Gainesville Llc. It is protected by 18 US drug patents filed from 2013 to 2020. Out of these, 16 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 12, 2034. Details of Zohydro Er's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10092559 | Abuse resistant pharmaceutical compositions |
Sep, 2034
(9 years from now) | Active |
| US9452163 | Abuse resistant pharmaceutical compositions |
Sep, 2034
(9 years from now) | Active |
| US9486451 | Abuse resistant pharmaceutical compositions |
Sep, 2034
(9 years from now) | Active |
| US9713611 | Abuse resistant pharmaceutical compositions |
Sep, 2034
(9 years from now) | Active |
| US9132096 | Abuse resistant pharmaceutical compositions |
Sep, 2034
(9 years from now) | Active |
| US9421200 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US9333201 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US9339499 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US9265760 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US9433619 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US10322120 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US9326982 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US10028946 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US9610286 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US10722511 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US10456393 | Treating pain in patients with hepatic impairment |
Jul, 2033
(8 years from now) | Active |
| US6902742 | Multiparticulate modified release composition |
Nov, 2019
(5 years ago) |
Expired
|
| US6228398 | Multiparticulate modified release composition |
Nov, 2019
(5 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Zohydro Er's patents.
Latest Legal Activities on Zohydro Er's Patents
Given below is the list of recent legal activities going on the following patents of Zohydro Er.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 01 Jul, 2024 | US9486451 |
| Maintenance Fee Reminder Mailed Critical | 20 May, 2024 | US9452163 |
| Maintenance Fee Reminder Mailed Critical | 29 Apr, 2024 | US9433619 |
| Maintenance Fee Reminder Mailed Critical | 15 Apr, 2024 | US9421200 |
| Maintenance Fee Reminder Mailed Critical | 18 Mar, 2024 | US10722511 |
| Expire Patent Critical | 04 Dec, 2023 | US10456393 |
| Expire Patent Critical | 24 Jul, 2023 | US10322120 |
| Maintenance Fee Reminder Mailed Critical | 19 Jun, 2023 | US10456393 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Mar, 2023 | US9132096 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 06 Feb, 2023 | US10322120 |
FDA has granted several exclusivities to Zohydro Er. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zohydro Er, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zohydro Er.
Exclusivity Information
Zohydro Er holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Zohydro Er's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 25, 2016 |
US patents provide insights into the exclusivity only within the United States, but Zohydro Er is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Zohydro Er's family patents as well as insights into ongoing legal events on those patents.
Zohydro Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zohydro Er's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 12, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zohydro Er Generic API suppliers:
Hydrocodone Bitartrate is the generic name for the brand Zohydro Er. 1 company has already filed for the generic of Zohydro Er. Check out the entire list of companies who have already received approval for Zohydro Er's generic
How can I launch a generic of Zohydro Er before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zohydro Er's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zohydro Er's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Zohydro Er -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg | 26 Feb, 2014 | 1 | 01 Nov, 2019 | Extinguished |
Alternative Brands for Zohydro Er
Zohydro Er which is used for managing pain in patients with hepatic impairment., has several other brand drugs in the same treatment category and using the same active ingredient (Hydrocodone Bitartrate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Btcp Pharma |
| |||
| Fresenius Kabi Usa |
| |||
| Genus |
| |||
| Tersera |
| |||
| Upjohn |
| |||
| Zyla |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Hydrocodone Bitartrate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
| |
| Purdue Pharma Lp |
| |
| Sovereign Pharms |
| |
| Teva Branded Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Hydrocodone Bitartrate, Zohydro Er's active ingredient. Check the complete list of approved generic manufacturers for Zohydro Er
About Zohydro Er
Zohydro Er is a drug owned by Recro Gainesville Llc. It is used for managing pain in patients with hepatic impairment. Zohydro Er uses Hydrocodone Bitartrate as an active ingredient. Zohydro Er was launched by Recro Gainesville in 2013.
Approval Date:
Zohydro Er was approved by FDA for market use on 25 October, 2013.
Active Ingredient:
Zohydro Er uses Hydrocodone Bitartrate as the active ingredient. Check out other Drugs and Companies using Hydrocodone Bitartrate ingredient
Treatment:
Zohydro Er is used for managing pain in patients with hepatic impairment.
Dosage:
Zohydro Er is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 30MG | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 20MG | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 40MG | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 50MG | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 15MG | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |