KYBELLA Drug Patent Profile

When do Kybella patents expire, 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
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	9,522,155		Y
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	10,500,214		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
Portugal	2422789
European Patent Office	2380576	Utilisation du désoxycholate de sodium pour l' élimination non chirurgicale de graisse (Use of sodium deoxycholate for the non-surgical removal of fat)
Poland	2407475
United Kingdom	2452358	Preparation of bile acids and intermediates thereof
Costa Rica	11174	COMPOSICION, METODO Y PREPARACION DEL ACIDO BILIAR SINTETICO
United Kingdom	0912493

Supplementary Protection Certificates for KYBELLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1758590	PA2017006	Lithuania		PRODUCT NAME: DEZOKSICHOLIO RUGSTIES NATRIO DRUSKA; REGISTRATION NO/DATE: LT/1/16/3960/001 20160909
3692995	301229	Netherlands		PRODUCT NAME: DEOXYCHOLAAT; NATIONAL REGISTRATION NO/DATE: RVG120593 20170804; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
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	122020000056	Germany		PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: EWR IS/1/16/071/01 20160729

Market Dynamics and Financial Trajectory for KYBELLA (Deoxycholic Acid)

Last updated: July 27, 2025

Introduction

KYBELLA, a branded injectable formulation of deoxycholic acid, is approved by the U.S. Food and Drug Administration (FDA) for reduction of submental fat—commonly known as “double chin”—in adults. Since its approval in 2015, the drug has stimulated significant interest within the aesthetic medicine sector. Analyzing its market landscape and projecting its financial trajectory provides insights critical for stakeholders in pharmaceutical development, investment, and healthcare services.

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Market Overview and Key Drivers

Growing Demand for Non-Invasive Aesthetic Procedures

The global aesthetic medicine market has experienced rapid expansion, fueled by increasing consumer preference for minimally invasive procedures over traditional surgical interventions. KYBELLA capitalizes on this trend, offering an outpatient, non-surgical alternative to liposuction or neck lifts. According to the American Society of Plastic Surgeons, nonsurgical facial procedures' revenues increased by approximately 45% from 2015 to 2019, reflecting consumer demand directly impacting KYBELLA’s market.

Aesthetic Appeal and Demographic Trends

The global middle-aged population exhibiting submental fat concerns represents a primary demand segment. Market studies emphasize rising disposable incomes, social media influence, and shifting beauty standards catalyzing a surge in aesthetic procedures among diverse demographic brackets, including men—approximately 15-20% of KYBELLA users globally—and younger adults.

Regulatory Approvals and Market Expansion

Post-FDA approval, KYBELLA secured additional approvals in markets such as Europe, Canada, and Asia-Pacific, expanding its footprint. The European approval in 2015, coupled with regional marketing strategies, has significantly enhanced market access and revenue potential.

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Market Dynamics

Competitive Landscape

While KYBELLA boasts a dominant position, its competitors include lipolytic agents and emerging non-invasive technologies. Notable competitors comprise:

• Surgical Alternatives: Liposuction remains a gold standard but lacks the non-invasive appeal.
• Other Injectables: Alternative fat reduction agents are under clinical exploration but have yet to gain market traction.
• Device-Based Technologies: Cryolipolysis (e.g., CoolSculpting) and ultrasound-based treatments for non-invasive fat reduction directly challenge KYBELLA's market share.

Pricing Strategies and Reimbursement

Pricing varies globally, typically ranging from $600 to $1,200 per treatment session (multiple sessions often required). Insurance reimbursement is limited as many procedures are cosmetic; however, emerging healthcare policies emphasizing patient satisfaction may influence future reimbursement protocols.

Technological Innovations and Pipeline

Kybella's active ingredient, deoxycholic acid, leverages natural bile acids for fat cell destruction, with ongoing research exploring optimized formulations and combination therapies. Innovations aiming to reduce treatment sessions or enhance efficacy could recalibrate market dynamics.

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Financial Trajectory and Revenue Projections

Historical Financial Performance

Since approval, KYBELLA has demonstrated robust growth. According to MarketResearch.com and industry insights, the drug generated approximately $250 million in global sales in 2019, with a compound annual growth rate (CAGR) of around 20-25% in the initial years. Peak revenue projections suggest potential to surpass $500 million annually as the brand penetrates new markets and expands indications.

Future Revenue Drivers

• Market Penetration in Emerging Economies: Expansion into Asia-Pacific and Latin America may unlock substantial demand, considering increasing middle-class populations seeking aesthetic treatments.
• Brand Extension and Off-Label Uses: Regulatory approvals for adjacent indications, such as submental fat in patients with obesity, remain under clinical review and could diversify revenue streams.
• Increasing Consumer Awareness: Digital marketing and celebrity endorsement accelerate consumer acceptance, fostering repeat treatments and brand loyalty.

Challenges Impacting Financial Trajectory

• Market Saturation: In mature markets like the US and Europe, saturation may slow growth; thus, focusing on untapped regions is imperative.
• Competitive Disruption: Innovations in non-injectable technologies could displace KYBELLA’s market share unless continuous differentiation is achieved.
• Pricing Pressures: Cost containment measures by insurers and healthcare providers may pressure pricing and profit margins.

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Strategic Outlook

Market Expansion Strategies

Manufacturers should prioritize geographical expansion, especially in regions with rising aesthetic procedure volumes, such as China and India. Establishing local regulatory pathways and tailoring marketing campaigns are essential.

Product Innovation and Diversification

Developing formulations with enhanced potency, reduced treatment sessions, or combining KYBELLA with adjunct therapies (e.g., skin tightening agents) can extend product lifecycle and market share.

Partnerships and Alliances

Collaborations with clinics, aesthetic service providers, and technology firms can foster comprehensive treatment platforms, boosting adoption and market reach.

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Conclusion

KYBELLA’s market dynamics hinge on demographic trends, technological innovation, and regional expansion. Its financial trajectory remains promising, bolstered by growing consumer demand for non-invasive aesthetic solutions and geographic diversification. However, sustained growth depends on navigating competitive pressures, advancing product offerings, and leveraging global market opportunities.

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Key Takeaways

• KYBELLA has established a strong foothold in minimally invasive fat reduction, with revenue growth driven by demographic shifts and technological differentiation.
• Market expansion into emerging regions is vital to unlock future revenue streams.
• Competition from technology-based non-invasive procedures necessitates continual innovation and strategic marketing.
• Pricing strategies and reimbursement policies will significantly influence profitability in mature versus developing markets.
• Strategic partnerships, pipeline innovation, and regional regulatory approvals will shape KYBELLA’s financial trajectory through 2025 and beyond.

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FAQs

1. What factors have contributed to KYBELLA’s rapid market adoption?
Consumer preference for non-invasive procedures, demographic shifts favoring aesthetic treatments, and effective marketing strategies have accelerated KYBELLA's adoption globally.

2. How does KYBELLA compare financially to traditional surgical options?
While surgical procedures such as liposuction offer more dramatic results with fewer sessions, KYBELLA provides a safer, outpatient alternative, albeit often requiring multiple treatments, which influences its revenue model.

3. What regions present the greatest growth opportunities for KYBELLA?
Emerging markets in Asia-Pacific and Latin America offer significant growth potential due to increasing disposable incomes, expanding aesthetic services, and rising awareness.

4. How might technological advancements impact KYBELLA’s market share?
Innovations in non-injectable fat reduction methods and improvements in injectable formulations could challenge KYBELLA’s dominance unless it continues to innovate and adapt.

5. What regulatory or reimbursement challenges could influence KYBELLA’s future sales?
Limited reimbursement in some markets, regulatory differences, and evolving healthcare policies emphasizing cost-effective aesthetic treatments could constrain revenue growth.

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References

[1] American Society of Plastic Surgeons. “2019 Plastic Surgery Statistics Report.”
[2] MarketResearch.com. “Global Aesthetic Medicine Market Analysis.”
[3] U.S. Food and Drug Administration. “FDA Approval Documents for KYBELLA.”
[4] Global Industry Analysts. “Non-Invasive Aesthetic Devices and Treatments” Reports.
[5] Industry Experts. “Forecasting the Future of Injectable Fat Reduction Agents,” Journal of Cosmetic Dermatology.