Clindesse is a drug owned by Padagis Us Llc. It is protected by 3 US drug patents filed from 2013 to 2018. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 02, 2026. Details of Clindesse'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). | |||
| US9789057 | Pharmaceutical delivery system |
Dec, 2026
(2 years from now) | Active |
| US6899890 | Bioadhesive drug delivery system |
Apr, 2023
(1 year, 6 months ago) |
Expired
|
| US5993856 | Pharmaceutical preparations and methods for their administration |
Nov, 2017
(7 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 Clindesse's patents.
Latest Legal Activities on Clindesse's Patents
Given below is the list of recent legal activities going on the following patents of Clindesse.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Apr, 2021 | US9789057 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Oct, 2017 | US9789057 |
| Recordation of Patent Grant Mailed Critical | 17 Oct, 2017 | US9789057 |
| Issue Notification Mailed Critical | 27 Sep, 2017 | US9789057 |
| Dispatch to FDC | 13 Sep, 2017 | US9789057 |
| Application Is Considered Ready for Issue Critical | 12 Sep, 2017 | US9789057 |
| Issue Fee Payment Received Critical | 11 Sep, 2017 | US9789057 |
| Issue Fee Payment Verified Critical | 11 Sep, 2017 | US9789057 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 06 Sep, 2017 | US9789057 |
| Mail Notice of Allowance Critical | 12 Jun, 2017 | US9789057 |
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 Clindesse and ongoing litigations to help you estimate the early arrival of Clindesse generic.
Clindesse's Litigations
Clindesse been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 04, 2014, against patent number US9789057. The petitioner , challenged the validity of this patent, with Thomas C. Riley et al as the respondent. Click below to track the latest information on how companies are challenging Clindesse's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9789057 | September, 2014 |
Decision
(23 Mar, 2017) | Thomas C. Riley et al | |
US patents provide insights into the exclusivity only within the United States, but Clindesse 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 Clindesse's family patents as well as insights into ongoing legal events on those patents.
Clindesse's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Clindesse's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 02, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Clindesse Generic API suppliers:
Clindamycin Phosphate is the generic name for the brand Clindesse. 42 different companies have already filed for the generic of Clindesse, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Clindesse's generic
How can I launch a generic of Clindesse before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Clindesse's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Clindesse'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 Clindesse -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.02 | 05 Feb, 2015 | 1 | 27 Apr, 2023 | Extinguished |
Alternative Brands for Clindesse
Clindesse which is used for treating bacterial vaginosis., has several other brand drugs in the same treatment category and using the same active ingredient (Clindamycin Phosphate). 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 | ||
|---|---|---|---|---|
| Bausch |
| |||
| Pfizer |
| |||
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. Clindamycin Phosphate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |||||
|---|---|---|---|---|---|---|
| Almirall |
| |||||
| Bausch |
| |||||
| Norvium Bioscience |
| |||||
| Organon Llc |
| |||||
| Pfizer |
| |||||
| Stiefel |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Clindamycin Phosphate, Clindesse's active ingredient. Check the complete list of approved generic manufacturers for Clindesse
About Clindesse
Clindesse is a drug owned by Padagis Us Llc. It is used for treating bacterial vaginosis. Clindesse uses Clindamycin Phosphate as an active ingredient. Clindesse was launched by Padagis Us in 2004.
Approval Date:
Clindesse was approved by FDA for market use on 30 November, 2004.
Active Ingredient:
Clindesse uses Clindamycin Phosphate as the active ingredient. Check out other Drugs and Companies using Clindamycin Phosphate ingredient
Treatment:
Clindesse is used for treating bacterial vaginosis.
Dosage:
Clindesse is available in cream form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2% BASE | CREAM | Prescription | VAGINAL |