Kybella is a drug owned by Abbvie Inc. It is protected by 15 US drug patents filed from 2015 to 2020 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 02, 2030. Details of Kybella's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US8242294 | Synthetic bile acid compositions and methods |
May, 2028
(3 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8846066 | Methods and related compositions for reduction of fat and skin tightening |
Feb, 2025
(6 months from now) | Active |
| US8298556 | Methods and related compositions for the non-surgical removal of fat |
Aug, 2025
(1 year, 6 days from now) | Active |
| US7622130 | Methods and compositions for the non-surgical removal of fat |
Dec, 2027
(3 years from now) | Active |
| US7754230 | Methods and related compositions for reduction of fat |
Dec, 2027
(3 years from now) | Active |
| US8883770 | Synthetic bile acid compositions and methods |
Feb, 2028
(3 years from now) | Active |
| US9636349 | Synthetic bile acid compositions and methods |
Feb, 2028
(3 years from now) | Active |
| US9522155 | Synthetic bile acid compositions and methods |
Feb, 2028
(3 years from now) | Active |
| US8546367 | Synthetic bile acid compositions and methods |
Feb, 2028
(3 years from now) | Active |
| US8461140 | Synthetic bile acid compositions and methods |
Feb, 2028
(3 years from now) | Active |
| US9949986 | Synthetic bile acid compositions and methods |
Feb, 2028
(3 years from now) | Active |
| US10500214 | Formulations of deoxycholic acid and salts thereof |
Mar, 2030
(5 years from now) | Active |
| US8101593 | Formulations of deoxycholic acid and salts thereof |
Mar, 2030
(5 years from now) | Active |
| US8367649 | Formulations of deoxycholic acid and salts thereof |
Mar, 2030
(5 years from now) | Active |
| US8653058 | Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits |
Mar, 2030
(5 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 Kybella's patents.
Latest Legal Activities on Kybella's Patents
Given below is the list of recent legal activities going on the following patents of Kybella.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jul, 2024 | US8367649 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 May, 2024 | US9522155 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Mar, 2024 | US8298556 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2024 | US8242294 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Jun, 2023 | US8101593 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 May, 2023 | US10500214 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Feb, 2022 | US8846066 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Dec, 2021 | US7754230 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Sep, 2021 | US9949986 |
| Email Notification | 26 Jul, 2021 | US8367649 |
US patents provide insights into the exclusivity only within the United States, but Kybella 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 Kybella's family patents as well as insights into ongoing legal events on those patents.
Kybella's family patents
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Generic Launch
Generic Release Date:
Kybella's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 02, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kybella Generics:
Deoxycholic Acid is the generic name for the brand Kybella. 1 company has already filed for the generic of Kybella. Check out the entire list of companies who have already received approval for Kybella's generic
How can I launch a generic of Kybella before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kybella's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kybella'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 Kybella -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/mL (2 mL) | 13 Jul, 2018 | 1 | 02 Apr, 2021 | 02 Mar, 2030 | Deferred |
About Kybella
Kybella is a drug owned by Abbvie Inc. It is used for reducing submental fat volume in adults with moderate to severe convexity or fullness in the submental area. Kybella uses Deoxycholic Acid as an active ingredient. Kybella was launched by Abbvie in 2015.
Market Authorisation Date:
Kybella was approved by FDA for market use on 29 April, 2015.
Active Ingredient:
Kybella uses Deoxycholic Acid as the active ingredient. Check out other Drugs and Companies using Deoxycholic Acid ingredient
Treatment:
Kybella is used for reducing submental fat volume in adults with moderate to severe convexity or fullness in the submental area.
Dosage:
Kybella is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG/2ML (10MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |