Rescula is a drug owned by Sucampo Pharma Americas Llc. It is protected by 3 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 09, 2021. Details of Rescula'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). | |||
| US6458836 | Treatment of ocular hypertension and glaucoma |
Jul, 2021
(3 years ago) |
Expired
|
| US6770675 | Compositions and methods for reducing ocular hypertension |
Nov, 2018
(6 years ago) |
Expired
|
| US5221763 | Prostaglandins of the F series |
Jul, 2012
(12 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 Rescula's patents.
Latest Legal Activities on Rescula's Patents
Given below is the list of recent legal activities going on the following patents of Rescula.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 15 May, 2009 | US6458836 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 28 Mar, 2006 | US6458836 |
| Recordation of Patent Grant Mailed Critical | 03 Aug, 2004 | US6770675 |
| Patent Issue Date Used in PTA Calculation Critical | 03 Aug, 2004 | US6770675 |
| Issue Notification Mailed Critical | 15 Jul, 2004 | US6770675 |
| Receipt into Pubs | 02 Jul, 2004 | US6770675 |
| Dispatch to FDC | 30 Jun, 2004 | US6770675 |
| Application Is Considered Ready for Issue Critical | 30 Jun, 2004 | US6770675 |
| Receipt into Pubs | 29 Jun, 2004 | US6770675 |
| Receipt into Pubs | 26 May, 2004 | US6770675 |
US patents provide insights into the exclusivity only within the United States, but Rescula 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 Rescula's family patents as well as insights into ongoing legal events on those patents.
Rescula's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rescula's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 09, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rescula Generics:
There are no approved generic versions for Rescula as of now.
How can I launch a generic of Rescula before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rescula's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rescula'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 Rescula -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0015 | 12 May, 2014 | 1 | 09 Jul, 2021 | Extinguished |
About Rescula
Rescula is a drug owned by Sucampo Pharma Americas Llc. It is used for treating ocular hypertension. Rescula uses Unoprostone Isopropyl as an active ingredient. Rescula was launched by Sucampo Pharma Llc in 2000.
Approval Date:
Rescula was approved by FDA for market use on 03 August, 2000.
Active Ingredient:
Rescula uses Unoprostone Isopropyl as the active ingredient. Check out other Drugs and Companies using Unoprostone Isopropyl ingredient
Treatment:
Rescula is used for treating ocular hypertension.
Dosage:
Rescula is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS | Discontinued | OPHTHALMIC |