Zipsor is a drug owned by Assertio Therapeutics Inc. It is protected by 8 US drug patents filed from 2013 to 2017. Out of these, 6 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 24, 2029. Details of Zipsor'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). | |||
| US9561200 | Method of treating post-surgical acute pain |
Feb, 2029
(4 years from now) | Active |
| US7939518 | Method of treating post-surgical acute pain |
Feb, 2029
(4 years from now) | Active |
| US8623920 | Method of treating post-surgical acute pain |
Feb, 2029
(4 years from now) | Active |
| US7884095 | Method of treating post-surgical acute pain |
Feb, 2029
(4 years from now) | Active |
| US8110606 | Method of treating post-surgical acute pain |
Feb, 2029
(4 years from now) | Active |
| US7662858 | Method of treating post-surgical acute pain |
Feb, 2029
(4 years from now) | Active |
| US6365180 | Oral liquid compositions |
Jul, 2019
(5 years ago) |
Expired
|
| US6287594 | Oral liquid compositions |
Jan, 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 Zipsor's patents.
Latest Legal Activities on Zipsor's Patents
Given below is the list of recent legal activities going on the following patents of Zipsor.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Aug, 2023 | US8110606 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Nov, 2022 | US7939518 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Aug, 2022 | US7884095 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Aug, 2021 | US7662858 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Aug, 2020 | US9561200 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Aug, 2019 | US8110606 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Nov, 2018 | US7939518 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Aug, 2018 | US7884095 |
| Recordation of Patent Grant Mailed Critical | 07 Feb, 2017 | US9561200 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Feb, 2017 | US9561200 |
FDA has granted several exclusivities to Zipsor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zipsor, 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 Zipsor.
Exclusivity Information
Zipsor holds 2 exclusivities. All of its exclusivities have expired in 2024. Details of Zipsor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jun 16, 2012 |
| New Patient Population(NPP) | May 25, 2024 |
US patents provide insights into the exclusivity only within the United States, but Zipsor 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 Zipsor's family patents as well as insights into ongoing legal events on those patents.
Zipsor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zipsor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 24, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zipsor Generic API suppliers:
Diclofenac Potassium is the generic name for the brand Zipsor. 17 different companies have already filed for the generic of Zipsor, with Amici Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zipsor's generic
How can I launch a generic of Zipsor before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zipsor's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zipsor'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 Zipsor -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg | 14 Nov, 2012 | 1 | 23 Feb, 2016 | 24 Feb, 2029 | Extinguished |
Alternative Brands for Zipsor
Zipsor which is used for relief of mild to moderate acute pain as a nonsteroidal anti-inflammatory drug., has several other brand drugs using the same active ingredient (Diclofenac Potassium). 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 | |
|---|---|---|
| Assertio |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Diclofenac Potassium, Zipsor's active ingredient. Check the complete list of approved generic manufacturers for Zipsor
About Zipsor
Zipsor is a drug owned by Assertio Therapeutics Inc. It is used for relief of mild to moderate acute pain as a nonsteroidal anti-inflammatory drug. Zipsor uses Diclofenac Potassium as an active ingredient. Zipsor was launched by Assertio in 2009.
Approval Date:
Zipsor was approved by FDA for market use on 16 June, 2009.
Active Ingredient:
Zipsor uses Diclofenac Potassium as the active ingredient. Check out other Drugs and Companies using Diclofenac Potassium ingredient
Treatment:
Zipsor is used for relief of mild to moderate acute pain as a nonsteroidal anti-inflammatory drug.
Dosage:
Zipsor is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | CAPSULE | Prescription | ORAL |