Fleqsuvy is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 29, 2037. Details of Fleqsuvy'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). | |||
| US11324696 | Suspensions and diluents for metronidazole and baclofen |
Sep, 2037
(12 years from now) | Active |
| US11446246 | Suspensions and diluents for metronidazole and baclofen |
Sep, 2037
(12 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 Fleqsuvy's patents.
Latest Legal Activities on Fleqsuvy's Patents
Given below is the list of recent legal activities going on the following patents of Fleqsuvy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 20 Sep, 2022 | US11446246 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Sep, 2022 | US11446246 |
| Email Notification Critical | 01 Sep, 2022 | US11446246 |
| Issue Notification Mailed Critical | 31 Aug, 2022 | US11446246 |
| Dispatch to FDC | 24 Aug, 2022 | US11446246 |
| Application Is Considered Ready for Issue Critical | 24 Aug, 2022 | US11446246 |
| Email Notification Critical | 05 Aug, 2022 | US11446246 |
| Application ready for PDX access by participating foreign offices Critical | 04 Aug, 2022 | US11446246 |
| PG-Pub Issue Notification Critical | 04 Aug, 2022 | US11446246 |
| Issue Fee Payment Received Critical | 08 Jul, 2022 | US11446246 |
US patents provide insights into the exclusivity only within the United States, but Fleqsuvy 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 Fleqsuvy's family patents as well as insights into ongoing legal events on those patents.
Fleqsuvy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fleqsuvy's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 29, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fleqsuvy Generic API suppliers:
Baclofen is the generic name for the brand Fleqsuvy. 33 different companies have already filed for the generic of Fleqsuvy, with Rubicon having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fleqsuvy's generic
How can I launch a generic of Fleqsuvy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fleqsuvy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fleqsuvy'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 Fleqsuvy -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg/5 mL | 20 May, 2022 | 1 | 08 Jun, 2023 | 29 Sep, 2037 | Eligible |
Alternative Brands for Fleqsuvy
Fleqsuvy which is used for reducing spasticity in multiple sclerosis patients., has several other brand drugs using the same active ingredient (Baclofen). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Baclofen, Fleqsuvy's active ingredient. Check the complete list of approved generic manufacturers for Fleqsuvy
About Fleqsuvy
Fleqsuvy is a drug owned by Azurity Pharmaceuticals Inc. It is used for reducing spasticity in multiple sclerosis patients. Fleqsuvy uses Baclofen as an active ingredient. Fleqsuvy was launched by Azurity in 2022.
Can you believe Fleqsuvy received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Fleqsuvy was approved by FDA for market use on 04 February, 2022.
Active Ingredient:
Fleqsuvy uses Baclofen as the active ingredient. Check out other Drugs and Companies using Baclofen ingredient
Treatment:
Fleqsuvy is used for reducing spasticity in multiple sclerosis patients.
Dosage:
Fleqsuvy is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG/5ML | SUSPENSION | Prescription | ORAL |