Kybella Patent Expiration

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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8242294 Synthetic bile acid compositions and methods
May, 2028

(3 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8101593 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
US8367649 Formulations of deoxycholic acid and salts thereof
Mar, 2030

(5 years from now)

Active
US10500214 Formulations of deoxycholic acid and salts thereof
Mar, 2030

(5 years from now)

Active
US9522155 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
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
US8883770 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
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
US8298556 Methods and related compositions for the non-surgical removal of fat
Aug, 2025

(7 months from now)

Active
US8846066 Methods and related compositions for reduction of fat and skin tightening
Feb, 2025

(2 months 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.

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

Activity Date Patent Number
Patent litigations
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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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

Kybella has patent protection in a total of 35 countries. It's US patent count contributes only to 32.6% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Kybella.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


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 Generic API suppliers:

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.

Approval 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