Xaciato Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Xaciato.

Activity Date Patent Number
Patent litigations
Change in Power of Attorney (May Include Associate POA) 29 Dec, 2021 US11129896
Email Notification 29 Dec, 2021 US11129896
Correspondence Address Change 27 Dec, 2021 US11129896
Patent Issue Date Used in PTA Calculation 28 Sep, 2021 US11129896
Recordation of Patent Grant Mailed 28 Sep, 2021 US11129896
Email Notification 09 Sep, 2021 US11129896
Issue Notification Mailed 08 Sep, 2021 US11129896
Application Is Considered Ready for Issue 25 Aug, 2021 US11129896
Dispatch to FDC 25 Aug, 2021 US11129896
Issue Fee Payment Verified 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 1 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

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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

Xaciato has patent protection in a total of 10 countries. It's US patent count contributes only to 35.7% of its total global patent coverage. Click below to unlock the full patent family tree for Xaciato.

Family Patents

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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
Veltin
Bausch
Acanya
Cabtreo
Clindagel
Onexton
Ziana
Norvium Bioscience
Evoclin
Padagis Us
Clindesse
Pfizer
Cleocin
Stiefel
Duac


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