Zorvolex is a drug owned by Zyla Life Sciences Us Inc. It is protected by 7 US drug patents filed from 2014 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 23, 2030. Details of Zorvolex'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). | |||
| US9180095 | Formulation of diclofenac |
Apr, 2030
(4 years from now) | Active |
| US8999387 | Formulation of diclofenac |
Apr, 2030
(4 years from now) | Active |
| US9186328 | Formulation of diclofenac |
Apr, 2030
(4 years from now) | Active |
| US9180096 | Formulation of diclofenac |
Apr, 2030
(4 years from now) | Active |
| US9017721 | Formulation of diclofenac |
Apr, 2030
(4 years from now) | Active |
| US8679544 | Formulation of diclofenac |
Apr, 2030
(4 years from now) | Active |
| US9173854 | Formulation of diclofenac |
Apr, 2030
(4 years from now) | Active |
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 Zorvolex's patents.
Latest Legal Activities on Zorvolex's Patents
Given below is the list of recent legal activities going on the following patents of Zorvolex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 17 May, 2023 | US9186328 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 10 May, 2023 | US9180095 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 10 May, 2023 | US9180096 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 03 May, 2023 | US9173854 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 28 Oct, 2022 | US9017721 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 07 Oct, 2022 | US8999387 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 07 Jul, 2022 | US9017721 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 07 Jul, 2022 | US8999387 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 27 Sep, 2021 | US8679544 (Litigated) |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 17 May, 2019 | US9186328 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Zorvolex and ongoing
litigations to
help you estimate the early arrival of Zorvolex generic.
Zorvolex's Litigations
Zorvolex been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 28, 2015, against patent number US8999387. The petitioner Lupin Pharmaceuticals, Inc., challenged the validity of this patent, with iCeutica Pty Ltd. as the respondent. Click below to track the latest information on how companies are challenging Zorvolex's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9017721 | December, 2015 |
Institution Denied
(01 Jul, 2016) | iCeutica Pty Ltd. et al. | Lupin Pharmaceuticals, Inc. et al. |
| US9017721 | December, 2015 |
Terminated-Denied
(01 Jul, 2016) | iCeutica Pty Ltd. | Lupin Pharmaceuticals, Inc. |
| US8999387 | December, 2015 |
Institution Denied
(29 Jun, 2016) | iCeutica Pty Ltd. et al. | Lupin Pharmaceuticals, Inc. et al. |
| US8999387 | December, 2015 |
Terminated-Denied
(29 Jun, 2016) | iCeutica Pty Ltd. | Lupin Pharmaceuticals, Inc. |
FDA has granted some exclusivities to Zorvolex. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Zorvolex,
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
Zorvolex.
Exclusivity Information
Zorvolex holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Zorvolex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 18, 2016 |
| New Indication(I-692) | Aug 22, 2017 |
US patents provide insights into the exclusivity only within the United States, but
Zorvolex 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 Zorvolex's family patents as well as insights into
ongoing legal events
on those patents.
Zorvolex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zorvolex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 23, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zorvolex Generics:
There are no approved generic versions for Zorvolex as of now.
How can I launch a generic of Zorvolex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zorvolex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zorvolex'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 Zorvolex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 18 mg and 35 mg | 06 Jun, 2014 | 1 | 23 Apr, 2030 |
Alternative Brands for Zorvolex
Zorvolex which is used for managing pain., has several other brand drugs in the same treatment category and using the same active ingredient (Diclofenac). 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 |
| |||
| Recro Gainesville |
| |||
| Tersera |
| |||
| Upjohn |
| |||
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. Diclofenac. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Asio Holdings |
| ||
| Falcon Pharms |
| ||
| Fougera Pharms |
| ||
| Horizon |
| ||
| Ibsa |
| ||
| Ibsa Inst Bio |
| ||
| Javelin Pharms Inc |
| ||
| Nuvo Pharms Inc |
| ||
| Pfizer |
|
About Zorvolex
Zorvolex is a drug owned by Zyla Life Sciences Us Inc. It is used for managing pain. Zorvolex uses Diclofenac as an active ingredient. Zorvolex was launched by Zyla in 2013.
Approval Date:
Zorvolex was approved by FDA for market use on 18 October, 2013.
Active Ingredient:
Zorvolex uses Diclofenac as the active ingredient. Check out other Drugs and Companies using Diclofenac ingredient
Treatment:
Zorvolex is used for managing pain.
Dosage:
Zorvolex is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |