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 fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-one patent family members in thirty-seven 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:	141
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	15
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
Massachusetts General Hospital	Phase 1
Johns Hopkins University	Phase 1
Beer, Kenneth R., M.D., PA	Phase 4

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 fifteen 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	9,522,155		Y
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	8,101,593		Y

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

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	2380576
Hong Kong	1101062	USE OF A DETERGENT FOR THE NON-SURGICAL REMOVAL OF FAT
Argentina	112325	MÉTODO DE PREPARACIÓN DEL ÁCIDO BILIAR SINTÉTICO
United Kingdom	2452358	Preparation of bile acids and intermediates thereof

Supplementary Protection Certificates for KYBELLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122020000056	Germany		PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: EWR IS/1/16/071/01 20160729
3692995	301229	Netherlands		PRODUCT NAME: DEOXYCHOLAAT; NATIONAL REGISTRATION NO/DATE: RVG120593 20170804; FIRST REGISTRATION: IS IS/1/16/071/01 20160729

KYBELLA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: KYBELLA

Introduction to KYBELLA

KYBELLA, also known as deoxycholic acid, is a prescription medication approved by the FDA in 2015 for the improvement in the appearance of moderate to severe submental fat, commonly referred to as a "double chin"[3].

Mechanism of Action and Product Details

KYBELLA works by dissolving excess fat under the chin. It is administered via injection and targets the fat cells, leading to their destruction. The drug's mechanism of action involves the disruption of the cell membrane of adipocytes, resulting in cell lysis and the subsequent reduction of submental fat[1].

Historical Sales and Market Performance

Historically, KYBELLA has shown significant market performance since its approval. In the initial years following its launch, the drug saw steady sales growth. For instance, Allergan, the company that acquired Kythera Pharmaceuticals (the original developer of KYBELLA), reported substantial revenues from the drug as part of their overall financial results. In 2018, Allergan's total net revenues were $15.79 billion, with KYBELLA contributing to the aesthetic segment of their portfolio[2].

Forecasted Sales and Market Projections

DelveInsight's report on KYBELLA provides forecasted sales figures from 2019 to 2021. The report indicates that the drug was expected to continue its growth trajectory, driven by increasing demand for aesthetic treatments. Although specific forecasted figures for KYBELLA alone are not detailed in the public reports, the overall aesthetic segment of Allergan's portfolio showed growth, suggesting a positive outlook for KYBELLA[1].

Market Competition

The market for injection lipolysis, which includes KYBELLA, is competitive and growing. Other players in this market include Cynosure, Inc., and Alma Lasers. The competition is driven by the increasing demand for non-surgical aesthetic treatments. The injection lipolysis market is expected to grow at a CAGR of 9.5% from 2023 to 2033, reaching a market value of USD 939.5 million by 2033[4].

Emerging Therapies and Market Trends

The aesthetic market is continuously evolving with new therapies and technologies emerging. KYBELLA faces competition from other treatments such as surgical procedures like liposuction and abdominoplasty, as well as non-surgical alternatives. However, its unique mechanism of action and the convenience of being a non-surgical treatment have helped it maintain a strong market position[4].

Patent Exclusivity and Regulatory Milestones

KYBELLA's market exclusivity is a critical factor in its financial trajectory. The drug's patent expiry timeline and exclusivity details are closely monitored by industry analysts. Understanding these timelines helps in planning developmental strategies and anticipating market changes. As of the last available data, the report from DelveInsight provided detailed patent information and market exclusivity data, which are essential for both the original manufacturer and potential generic developers[1].

Financial Performance of Allergan

Allergan's financial performance provides insight into the overall health of the KYBELLA market. In 2019, Allergan reported total net revenues of $16.088 billion, with non-GAAP operating income of $7.314 billion. The aesthetic segment, which includes KYBELLA, contributed significantly to these figures. The company's financial results indicate a stable and growing revenue stream from its aesthetic products[5].

SWOT Analysis

A SWOT analysis of KYBELLA highlights its strengths, such as its unique mechanism of action and FDA approval, which give it a competitive edge. However, it also faces weaknesses like the need for multiple injections and potential side effects. Opportunities include the growing demand for non-surgical aesthetic treatments, while threats include market competition and regulatory changes[1].

Regional Analysis

The market for KYBELLA is not limited to one region; it is a global product with sales in North America, Europe, APAC, South America, and MEA. Regional analysis shows varying adoption rates and market sizes, with North America being a significant market due to high demand for aesthetic treatments[4].

Service Providers and Treatment Sites

KYBELLA is administered in various settings, including hospitals, specialty clinics, and other healthcare facilities. The treatment sites include facial fat, submental fat, abdominal fat, and others. The diversity in service providers and treatment sites contributes to the drug's widespread adoption and market reach[4].

Conclusion

KYBELLA has established itself as a key player in the aesthetic market, particularly in the segment of injection lipolysis. Its unique mechanism of action, coupled with the growing demand for non-surgical treatments, has driven its market success. The financial trajectory of KYBELLA is closely tied to the overall performance of Allergan and the broader aesthetic market trends.

Key Takeaways

• Market Growth: KYBELLA has seen steady growth since its FDA approval in 2015.
• Competitive Landscape: The drug competes in a growing market for injection lipolysis with a CAGR of 9.5% from 2023 to 2033.
• Financial Performance: Allergan's financial reports indicate a stable revenue stream from its aesthetic segment, which includes KYBELLA.
• Regulatory and Patent Exclusivity: Understanding patent timelines is crucial for market planning and generic development strategies.
• SWOT Analysis: KYBELLA's strengths include its unique mechanism and FDA approval, while it faces challenges like market competition and potential side effects.

FAQs

Q: What is KYBELLA used for? A: KYBELLA is used for the improvement in the appearance of moderate to severe submental fat, commonly referred to as a "double chin"[3].

Q: Who approved KYBELLA? A: KYBELLA was approved by the FDA in 2015[3].

Q: What is the mechanism of action of KYBELLA? A: KYBELLA works by dissolving excess fat under the chin through the disruption of the cell membrane of adipocytes, leading to cell lysis and the subsequent reduction of submental fat[1].

Q: What is the forecasted market growth for injection lipolysis? A: The injection lipolysis market, which includes KYBELLA, is expected to grow at a CAGR of 9.5% from 2023 to 2033, reaching a market value of USD 939.5 million by 2033[4].

Q: Who are the key competitors in the injection lipolysis market? A: Key competitors in the injection lipolysis market include Cynosure, Inc., and Alma Lasers, among others[4].

Sources

1. DelveInsight Report: "Kybella Drug Insight, 2019" - Valuates Reports
2. Allergan Financial Results: "Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results" - Allergan
3. FDA Approval: "Kythera's (KYTH) Double Chin Drug Kybella Gets FDA Nod" - Nasdaq
4. Market Report: "Injection Lipolysis Market Size, Share | CAGR of 9.5%" - Market.US
5. Allergan Financial Results 2019: "Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results" - PR Newswire