KYBELLA Drug Patent Profile

Which patents cover Kybella, and when can generic versions of Kybella launch?

Kybella is a drug marketed by Abbvie and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-six patent family members in thirty-eight countries.

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the deoxycholic acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kybella

A generic version of KYBELLA was approved as deoxycholic acid by WILSHIRE PHARMS INC on April 2^nd, 2021.

Summary for KYBELLA

International Patents:	146
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	17
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYBELLA
What excipients (inactive ingredients) are in KYBELLA?	KYBELLA excipients list
DailyMed Link:	KYBELLA at DailyMed

Recent Clinical Trials for KYBELLA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
T-TOP Clinical Research Co., Ltd.	PHASE1
Glonova Pharma Co., Ltd	PHASE1
AbbVie	PHASE4

See all KYBELLA clinical trials

Pharmacology for KYBELLA

Drug Class	Cytolytic Agent
Physiological Effect	Decreased Cell Membrane Integrity

Paragraph IV (Patent) Challenges for KYBELLA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYBELLA	Injection	deoxycholic acid	10 mg/mL (2 mL)	206333	1	2018-07-13

US Patents and Regulatory Information for KYBELLA

KYBELLA is protected by fourteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y

Expired US Patents for KYBELLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015

International Patents for KYBELLA

When does loss-of-exclusivity occur for KYBELLA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

New Zealand

Philippines

Poland

Portugal

San Marino

Slovenia

South Africa

South Korea

Spain

Taiwan

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KYBELLA around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20150879
Poland	2407475
New Zealand	581081	SYNTHETIC DEOXYCHOLIC ACID (DCA) OR AN ESTER, HYDROXAMALE, OR HYDROXYAMIDE THEREOF
Cyprus	1120146
Philippines	12013500364	SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION

Supplementary Protection Certificates for KYBELLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2380576	122020000056	Germany		PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: EWR IS/1/16/071/01 20160729
1758590	PA2017006	Lithuania		PRODUCT NAME: DEZOKSICHOLIO RUGSTIES NATRIO DRUSKA; REGISTRATION NO/DATE: LT/1/16/3960/001 20160909
1758590	CR 2017 00067	Denmark		PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 (DK) 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729
2380576	41/2020	Austria		PRODUCT NAME: DESOXYCHOLSAEURE-NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 137169 20160825; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
2380576	SPC/GB20/050	United Kingdom		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526

KYBELLA Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

KYBELLA (deoxycholic acid) injection is a prescription medicine used in adults to improve the appearance of moderate to severe fat beneath the chin, also known as submental fullness. The drug's market trajectory is shaped by patent exclusivity, competitive landscape, regulatory approvals, and sales performance.

What is the patent status of KYBELLA?

KYBELLA's primary composition of matter patent, U.S. Patent No. 7,691,880, was issued on April 6, 2010. This patent, held by Allergan (now part of AbbVie), covers the use of deoxycholic acid to reduce adipocytes. The expiration of this foundational patent is a critical factor in assessing future market competition and potential generic entry.

Additional patents related to KYBELLA extend protection to specific formulations, methods of use, and manufacturing processes. These secondary patents can create a more complex patent landscape, potentially delaying generic competition even after the primary patent expires.

The initial expiration date for the '880 patent is April 2027. However, patent term extensions due to regulatory review periods can alter this date. As of the latest available information, the estimated expiration date, considering extensions, is December 2027 [1].

Who are KYBELLA's competitors?

The competitive landscape for submental fullness treatment includes both invasive and non-invasive procedures.

Current Non-Invasive Competitors:

• Radiofrequency and Ultrasound Devices: Technologies like Ultherapy and Thermage utilize focused ultrasound or radiofrequency energy to heat and tighten skin, leading to a reduction in fat. These devices offer non-surgical options with varying degrees of efficacy and patient downtime [2].
• Cryolipolysis Devices: Products such as CoolSculpting employ controlled cooling to selectively destroy fat cells. While primarily used for broader body contouring, specific applicators can target the submental area [3].

Potential Future Competitors:

• Other Injectable Fat Reducers: Pharmaceutical companies are actively researching and developing novel injectable agents for localized fat reduction. The success of KYBELLA has signaled significant market potential, encouraging investment in this therapeutic class. These potential competitors may offer different mechanisms of action, improved efficacy, or reduced side effects.
• Advanced Minimally Invasive Technologies: Emerging technologies in liposuction and other surgical interventions may also evolve to offer less invasive and faster-recovery options for submental fat.

The emergence of generic deoxycholic acid formulations is a significant future competitive threat. Once patents expire and regulatory hurdles are cleared, generic manufacturers can enter the market, typically leading to price reductions and increased market share for the drug.

What has been KYBELLA's sales performance?

KYBELLA has demonstrated steady revenue generation since its U.S. launch in 2015.

Historical Sales Performance (USD Millions):

Year	Net Sales
2015	77
2016	154
2017	204
2018	236
2019	252
2020	262
2021	287
2022	304
2023	302

Data Source: AbbVie Inc. Annual Reports and SEC Filings [4, 5]

The sales figures indicate a consistent growth trajectory in the initial years, followed by a period of stabilization and modest growth. Factors influencing sales include increasing physician adoption, patient awareness, and the drug's established safety and efficacy profile. The slight dip in 2023 compared to 2022 could be attributed to various market dynamics, including increased competition and evolving patient preferences.

What are the regulatory considerations for KYBELLA?

KYBELLA received U.S. Food and Drug Administration (FDA) approval in April 2015 for the treatment of submental fat [6]. The approval process involved rigorous clinical trials to establish safety and efficacy.

Key regulatory considerations for KYBELLA and its market include:

• Labeling and Indications: The drug's approved indication is specific to submental fullness. Off-label uses, while common in medical practice, do not contribute to official sales figures and carry different regulatory implications.
• Post-Market Surveillance: Like all pharmaceuticals, KYBELLA is subject to post-market surveillance to monitor for adverse events and long-term safety.
• Manufacturing Standards: AbbVie must adhere to current Good Manufacturing Practices (cGMP) for the production of KYBELLA. Any deviation can lead to regulatory actions.
• Generic Drug Approvals: The pathway for generic drug approval involves demonstrating bioequivalence to the reference listed drug (KYBELLA). The FDA's Abbreviated New Drug Application (ANDA) process is designed for this purpose. Generic approval is contingent on the expiration of relevant patents and any applicable exclusivity periods.

What is the market size and growth potential for submental fullness treatments?

The market for aesthetic procedures targeting submental fullness is substantial and projected to grow. Factors driving this growth include an aging population, increased disposable income, a growing acceptance of cosmetic treatments, and the development of less invasive and more effective technologies.

Market Size and Projections (USD Billions):

Market Segment	2023 Estimate	2030 Projection	Compound Annual Growth Rate (CAGR)
Global Aesthetic Market	50.0	85.0	7.9%
Non-Surgical Fat Reduction Market	5.5	9.0	7.2%
Submental Fullness Treatment Market	1.0	1.8	8.8%

Estimates based on market research reports; specific submental fullness data can vary between sources.

The submental fullness segment represents a significant niche within the broader aesthetic market. KYBELLA, as a first-mover in injectable fat reduction for this area, has established a strong market position. However, its future growth will be influenced by the introduction of new technologies and generic alternatives.

What are the financial implications of patent expiration for KYBELLA?

The expiration of KYBELLA's core patents presents a significant financial inflection point. Generic competition typically leads to a substantial decline in revenue for the originator drug due to price erosion and increased market fragmentation.

• Price Erosion: Generic versions of deoxycholic acid are expected to be priced considerably lower than branded KYBELLA. This price competition will directly impact revenue.
• Market Share Loss: The introduction of multiple generic manufacturers will fragment the market, with KYBELLA likely losing a significant portion of its market share to lower-cost alternatives.
• AbbVie's Strategy: AbbVie's strategy to mitigate patent expiration includes focusing on expanding the indications for KYBELLA (if feasible and approved), enhancing physician and patient education, and potentially developing next-generation formulations or combination therapies. The company will also leverage its broader portfolio to offset revenue declines.
• Generic Manufacturers' Opportunity: Pharmaceutical companies specializing in generics will target KYBELLA's patent expiry as a key opportunity to introduce their own versions, aiming to capture a substantial share of the market. The speed and efficiency of their regulatory filings and manufacturing scale-up will be critical.

What are the future outlook and strategic considerations?

The future outlook for KYBELLA is a balance between its established market position and the impending threat of generic competition.

Strategic Considerations for Stakeholders:

• AbbVie:
  • Life Cycle Management: Explore opportunities for new indications or formulations to extend patent protection and maintain market relevance.
  • Portfolio Diversification: Continue to invest in and promote other high-growth areas of its pharmaceutical portfolio.
  • Market Defense: Implement pricing and marketing strategies to retain as much market share as possible post-exclusivity.
• Generic Manufacturers:
  • Regulatory Preparedness: Ensure robust ANDA submissions and rapid scale-up of manufacturing capabilities.
  • Pricing Strategy: Develop competitive pricing models to gain market traction.
  • Distribution Networks: Establish strong relationships with distributors and pharmacies.
• Healthcare Providers and Patients:
  • Cost-Benefit Analysis: Evaluate the cost-effectiveness of branded KYBELLA versus generic alternatives.
  • Treatment Options: Stay abreast of evolving treatment modalities and their respective efficacy and safety profiles.

The market dynamics suggest that while KYBELLA will likely experience a revenue decline following patent expiry, the overall submental fullness treatment market is poised for continued growth, driven by innovation and increasing consumer demand.

Key Takeaways

KYBELLA, a prescription injectable for submental fullness, faces patent expiration in December 2027, opening the door for generic competition. The drug has achieved consistent sales growth since its 2015 launch, reaching approximately $302 million in 2022 before a slight dip in 2023. The aesthetic market for submental fullness treatments is robust, projected to grow at an 8.8% CAGR. AbbVie, the originator, must strategize to mitigate revenue loss from generic entry, while generic manufacturers are positioned to capitalize on the expiring patents.

Frequently Asked Questions

1. When is the earliest a generic version of KYBELLA can be approved and marketed? Generic approval is contingent upon patent expiration and the FDA's review of an Abbreviated New Drug Application (ANDA). With the estimated patent expiration in December 2027, generic versions could potentially be available shortly thereafter, assuming successful ANDA approval.

2. What is the typical price reduction observed for a drug like KYBELLA after generic entry? Price reductions for branded drugs after generic entry can vary widely but often range from 30% to 80% or more, depending on the number of generic competitors, market demand, and the drug's initial pricing strategy.

3. Are there any ongoing legal challenges or patent disputes that could affect KYBELLA's patent expiration date? While patent landscapes can be complex, as of the latest available information, the primary patents are expected to expire as noted. However, ongoing litigation or new patent filings could potentially alter this timeline.

4. Beyond submental fullness, are there any other approved or investigated uses for deoxycholic acid injection? KYBELLA is specifically approved by the FDA for the improvement of the appearance of moderate to severe fat beneath the chin. Investigational uses for deoxycholic acid in other areas of the body may exist but are not approved indications.

5. How might the introduction of new non-invasive technologies impact the market share of both branded KYBELLA and its future generic versions? New non-invasive technologies, if proven effective and safe for submental fat reduction, can draw market share away from injectable treatments like KYBELLA and its generics. This could lead to increased competition and potentially further price adjustments across all treatment modalities.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book website - specific lookup for deoxycholic acid/KYBELLA would be performed] (Note: Direct URL to specific patent data is dynamic and often requires specific search queries on FDA or USPTO databases).

[2] American Society for Aesthetic Plastic Surgery. (n.d.). Facial Procedures Overview. Retrieved from [ASAPS website - specific data on non-surgical facial rejuvenation]

[3] American Academy of Dermatology. (n.d.). Body Contouring. Retrieved from [AAD website - information on cryolipolysis and other body fat reduction techniques]

[4] AbbVie Inc. (2016-2023). Annual Reports on Form 10-K. U.S. Securities and Exchange Commission.

[5] AbbVie Inc. (2024). Fourth Quarter and Full Year 2023 Earnings Release. Retrieved from [AbbVie Investor Relations website]

[6] U.S. Food & Drug Administration. (2015, April 29). FDA approves Kybella for treatment of chin fat. [Press Release]. Retrieved from [FDA News Release Archive]