Xaciato is a drug owned by Organon Llc. It is protected by 1 US drug patent 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 22, 2036. Details of Xaciato'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). | |||
| US11129896 | Topical formulations and treatments |
Sep, 2036
(11 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 Xaciato's patents.
Latest Legal Activities on Xaciato's Patents
Given below is the list of recent legal activities going on the following patents of Xaciato.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Dec, 2021 | US11129896 |
| Email Notification Critical | 29 Dec, 2021 | US11129896 |
| Correspondence Address Change Critical | 27 Dec, 2021 | US11129896 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Sep, 2021 | US11129896 |
| Recordation of Patent Grant Mailed Critical | 28 Sep, 2021 | US11129896 |
| Email Notification Critical | 09 Sep, 2021 | US11129896 |
| Issue Notification Mailed Critical | 08 Sep, 2021 | US11129896 |
| Application Is Considered Ready for Issue Critical | 25 Aug, 2021 | US11129896 |
| Dispatch to FDC | 25 Aug, 2021 | US11129896 |
| Issue Fee Payment Verified Critical | 23 Aug, 2021 | US11129896 |
FDA has granted several exclusivities to Xaciato. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xaciato, 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 Xaciato.
Exclusivity Information
Xaciato holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Xaciato's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 07, 2024 |
| Generating Antibiotic Incentives Now(GAIN) | Dec 07, 2029 |
US patents provide insights into the exclusivity only within the United States, but Xaciato 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 Xaciato's family patents as well as insights into ongoing legal events on those patents.
Xaciato's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xaciato's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 22, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xaciato Generic API suppliers:
Clindamycin Phosphate is the generic name for the brand Xaciato. 42 different companies have already filed for the generic of Xaciato, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xaciato's generic
Alternative Brands for Xaciato
Xaciato which is used for treating bacterial vaginosis with a single dose administration of clindamycin pharmaceutical gel formulation., has several other brand drugs 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 | |||||
|---|---|---|---|---|---|---|
| Almirall |
| |||||
| Bausch |
| |||||
| Norvium Bioscience |
| |||||
| Padagis Us |
| |||||
| Pfizer |
| |||||
| Stiefel |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Clindamycin Phosphate, Xaciato's active ingredient. Check the complete list of approved generic manufacturers for Xaciato
About Xaciato
Xaciato is a drug owned by Organon Llc. It is used for treating bacterial vaginosis with a single dose administration of clindamycin pharmaceutical gel formulation. Xaciato uses Clindamycin Phosphate as an active ingredient. Xaciato was launched by Organon Llc in 2021.
Approval Date:
Xaciato was approved by FDA for market use on 07 December, 2021.
Active Ingredient:
Xaciato uses Clindamycin Phosphate as the active ingredient. Check out other Drugs and Companies using Clindamycin Phosphate ingredient
Treatment:
Xaciato is used for treating bacterial vaginosis with a single dose administration of clindamycin pharmaceutical gel formulation.
Dosage:
Xaciato is available in gel form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2% BASE | GEL | Prescription | VAGINAL |