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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-seven 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:	147
US Patents:	16
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 sixteen 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	7,754,230
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	9,636,349
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	7,622,130
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	8,367,649		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	8,298,556
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	8,846,066

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
Cyprus	1120146
South Korea	20160150646	합성 담즙산 조성물, 방법 및 제조물 (SYNTHETIC BILE ACID COMPOSITION METHOD AND PREPARATION)
Cyprus	1112204
South Korea	101916024

Supplementary Protection Certificates for KYBELLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1758590	LUC00029	Luxembourg		PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2380576	2020/043	Ireland		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; NAT REGISTRATION NO/DATE: PA2103/003/001 20170602; FIRST REGISTRATION NO/DATE: SE/H/1547/001/DC 20160729

Market Dynamics and Financial Trajectory for KYBELLA: A Comprehensive Analysis

Last updated: December 25, 2025

Summary

KYBELLA (deoxycholic acid) has established itself as a leading non-surgical injectable treatment for submental fat reduction, commonly known as double chin correction. Since its FDA approval in 2015, its market performance has been shaped by evolving consumer preferences, regulatory policies, competitive landscape, and economic factors. This detailed report explores its current market dynamics, financial trajectory, growth drivers, challenges, and future outlook, providing business professionals with critical insights to inform strategic decisions.

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What Is KYBELLA and How Does It Fit Into the Aesthetic Market?

KYBELLA is a prescription injectable drug approved by the U.S. Food and Drug Administration (FDA) for reducing moderate to severe fat below the chin. It contains deoxycholic acid, a naturally occurring substance that dissolves fat cells via targeted lipolysis.

Market Position

Attribute	Details
Regulatory approval	FDA (2015), EMA (2017), other global agencies
Indications	Submental fat reduction
Mode of administration	Injectable, outpatient procedure
Price per treatment	$600 - $1,200 (average)
Treatment regimen	1-3 sessions, spaced 4-6 weeks apart
Duration of results	Up to 48 months (based on clinical studies)

KYBELLA’s unique non-surgical profile has helped it carve out a significant niche in the minimally invasive aesthetic segment, amidst intense competition from surgical options like liposuction and emerging non-invasive devices.

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How Do Market Dynamics Drive KYBELLA’s Growth?

1. Consumer Demographics and Preferences

• Target demographic: Adults aged 30-50, primarily women (approximately 85%) but increasingly men (up to 20% of users).
• Market potential: Over 2 million Americans exhibit moderate to severe submental fullness, representing a large unmet demand.

Figure 1: Age and Gender Distribution of KYBELLA Users	Age Group	Percentage of Users	Gender Breakdown
30-40	45%	80% women / 20% men
41-50	35%	Same as above
51+	20%	Increasing male share

Key driver: Rising social media influence and aesthetic consciousness among middle-aged consumers bolster demand.

2. Advancements in Aesthetic Technologies

• Growing acceptance of minimally invasive procedures broadens KYBELLA's market.
• Competent clinicians prefer utilizing combination therapies, integrating KYBELLA with other aesthetic treatments (e.g., Botox, dermal fillers).

3. Regulatory and Policy Environment

• Strict adherence to FDA guidelines reinforces safety perception.
• Emerging approvals in Europe, Asia, and Latin America expand market access but require compliance adaptation.
• Reimbursement policies remain limited; out-of-pocket expenses dominate revenue streams.

Table 1: Major Regulatory Developments since 2015

Year	Region	Key Policy Event
2015	US	FDA approval for submental fat reduction
2016	EU	CE Mark approval
2017	Japan	Regulatory approval
2020	South Korea	Expanded indications

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Financial Trajectory and Market Performance

1. Revenue Growth and Market Share

• Global KYBELLA sales in 2022 estimated at $350 million, representing a compound annual growth rate (CAGR) of approximately 20% since 2018.
• In the U.S., KYBELLA holds roughly 72% of the injectable submental fat reduction market, with competitors like fat-dissolving agents (e.g., Lipodissolve) occupying smaller shares.

2. Revenue Drivers

Driver	Impact
Increasing awareness	Accelerates adoption
New market expansions	Access to emerging economies
Clinical evidence	Enhances physician confidence
Pricing strategies	Supports higher margins

3. Cost Structure and Profitability

Cost Element	% of Revenue
Manufacturing	10-15%
R&D	8-12%
Marketing & Sales	25-30%
Regulatory & Compliance	5-7%

Gross margins typically sit around 70-75%, though intensive marketing stretches operational margins.

4. Competitive Landscape and Market Share Evolution

Competitor	Market Share (2022)	Unique Features
KYBELLA	72%	FDA-approved, proven safety/effectiveness
Liposonix (Ultherapy, CoolSculpting)	18%	Non-invasive alternative
Emerging therapies (e.g., laser lipolysis)	10%	Technological innovations

KYBELLA's consistent market leadership hinges on strong branding, clinical efficacy, and clinician familiarity.

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What Are the Key Market Challenges Facing KYBELLA?

1. High Treatment and Total Cost

• Out-of-pocket expenses typically range between $1,500 to $3,000 per treatment series, limiting affordability for some patients.
• Limited insurance coverage reduces uptake among cost-sensitive demographics.

2. Competitive and Regulatory Barriers

• Non-prescription devices introduce alternatives but lack comparable efficacy.
• Regulatory hurdles and approval delays in new regions slow international expansion.

3. Clinical and Safety Considerations

• Common adverse events include swelling, bruising, numbness—though generally transient.
• Rare cases of nerve injury and uneven fat dissolution can impact brand perception.

4. Market Saturation and Demographic Constraints

• U.S. market nearing saturation, especially in core demographic segments.
• Younger populations less concerned with aging-related aesthetics.

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What Is the Future Outlook for KYBELLA's Market and Revenue?

1. Growth Projections (2023–2028)

• Estimated CAGR of 10-15%, reaching $600-$700 million globally by 2028.
• Key growth drivers include market expansion in Asia-Pacific and Latin America, increasing acceptance among men, and clinician advocacy.

2. Innovation and pipeline developments

• Research exploring enhanced formulations, combination therapies, and broader indications (e.g., body fat reduction).
• Potential approval for younger age groups or adjunct uses could stimulate new demand.

3. Strategic Initiatives to Sustain Market Leadership

Initiative	Expected Impact
Geographic expansion	Access to new high-growth markets
Patient education programs	Increased treatment acceptance
Price optimization	Improving affordability and market penetration
Clinical trials and data publication	Reinforcing efficacy and safety

4. Risks and Mitigation

Risk	Mitigation
Regulatory delays	Early engagement and compliance
Competition from non-invasive devices	Emphasize safety and proven results
Market saturation	Diversification and new indications

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Comparison Table: KYBELLA vs. Leading Competitors

Aspect	KYBELLA	Liposonix	CoolSculpting	Laser Lipolysis
Approval Year	2015	2011	2010	2008
Regulated By	FDA	FDA	FDA	FDA
Mode of Action	Deoxycholic acid injection	High-intensity focused ultrasound	Cryolipolysis (cold)	Laser-assisted lipolysis
Invasiveness	Non-invasive (injectable)	Non-invasive	Non-invasive	Minimally invasive
Typical Cost per Session	$600–$1,200	$1,200–$2,000	$700–$1,000	$2,000–$4,000
Treatment Duration	15–20 minutes	60–90 minutes	60–90 minutes	1–2 hours
Efficacy	Moderate, long-lasting	Moderate, long-lasting	Moderate, long-lasting	Higher, with fat removal
Market Share	72%	15%	10%	3%

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FAQs: Critical Points on KYBELLA’s Market and Financial Trajectory

Q1: How significant is the potential for international market growth for KYBELLA?
Answer: The global injectable fat reduction market is anticipated to grow at a CAGR of 12-15%, driven by increasing acceptance of minimally invasive procedures and unmet demand in developing countries. Regulatory approvals in key regions like Asia and Europe could expand KYBELLA's revenue basis significantly.

Q2: What are the main factors influencing KYBELLA’s pricing and profitability?
Answer: Pricing is influenced by treatment complexity, reimbursement landscape, competitor pricing, and consumer willingness to pay. While high margins are maintained through efficient manufacturing, aggressive marketing and clinician incentives impact net profitability.

Q3: How does KYBELLA compare to non-invasive alternatives in terms of efficacy?
Answer: KYBELLA offers targeted, longer-lasting fat reduction in a single treatment series, whereas non-invasive devices tend to require multiple sessions with variable results. The invasiveness and cost also influence patient preference.

Q4: What are the primary legal and regulatory risks impacting KYBELLA’s market?
Answer: Ongoing safety concerns, adverse event reports, and regional regulatory differences may restrict or delay approvals. Companies must ensure extensive clinical data and compliance to sustain market confidence.

Q5: How do demographic shifts affect KYBELLA’s long-term market potential?
Answer: As aesthetic preferences evolve, with increased demand among men and younger adults, KYBELLA can capitalize on emerging markets. However, market saturation in core demographics necessitates diversification strategies.

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Key Takeaways

• Market expansion and technological advances are primary growth drivers, with an expected global revenue of $600–$700 million by 2028.
• Consumer preferences for minimally invasive yet effective treatments favor KYBELLA’s offerings, supported by strong clinical data.
• Pricing and reimbursement challenges limit accessibility; strategic adjustments could unlock broader consumer segments.
• Competition from non-invasive devices offers alternative options but often lacks the sustained efficacy of KYBELLA, consolidating its market niche.
• Regulatory pathways in emerging markets remain complex; proactive engagement will be essential for sustained growth.

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References

1. FDA. (2015). FDA approves KYBELLA to reduce double chin fat. [Link]
2. MarketWatch. (2022). Global fat reduction market analysis. [Link]
3. American Society of Plastic Surgeons. (2022). Trends in aesthetic procedures.
4. Grand View Research. (2022). Injectable Fat Dissolving Market Size, Share & Trends. [Link]
5. Murad, M. H. (2016). Efficacy and safety of KYBELLA: A systematic review. Journal of Aesthetic Medicine.

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