CABTREO Drug Patent Profile

When do Cabtreo patents expire, and what generic alternatives are available?

Cabtreo is a drug marketed by Bausch and is included in one NDA. There are eight patents protecting this drug.

This drug has twenty-eight patent family members in fifteen countries.

The generic ingredient in CABTREO is adapalene; benzoyl peroxide; clindamycin phosphate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the adapalene; benzoyl peroxide; clindamycin phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Cabtreo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 5, 2029. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CABTREO

International Patents:	28
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for CABTREO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CABTREO
What excipients (inactive ingredients) are in CABTREO?	CABTREO excipients list
DailyMed Link:	CABTREO at DailyMed

See drug prices for CABTREO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CABTREO

Constraining patent/regulatory exclusivity:

8,288,434

NDA:

216632

Dosage:

GEL;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CABTREO

Drug Class	Lincosamide Antibacterial Retinoid
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

US Patents and Regulatory Information for CABTREO

CABTREO is protected by eight US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,288,434.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	11,389,467		Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	12,138,278		Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	9,561,208		Y

International Patents for CABTREO

When does loss-of-exclusivity occur for CABTREO?

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

Australia

Brazil

Canada

China

Croatia

European Patent Office

Japan

Mexico

Portugal

Russian Federation

South Africa

South Korea

Spain

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 CABTREO around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2013122395	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ
Russian Federation	2010146038	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ
World Intellectual Property Organization (WIPO)	2009148584

Market Dynamics and Financial Trajectory for CABTREO

Introduction to CABTREO

CABTREO, a triple-combination topical treatment for acne vulgaris, has recently garnered significant attention in the pharmaceutical industry. Developed by Bausch Health Companies Inc., this drug has been approved by regulatory bodies in several countries, including the FDA in the United States and Health Canada.

Market Context: Acne Treatment Market

The global acne treatment market is projected to grow substantially, driven by the rising prevalence of acne and the launch of advanced drugs. The market size is expected to increase from $11.62 billion in 2024 to $17.48 billion by 2032, at a CAGR of 5.2% during the forecast period[1][4].

Segment Performance: Topical Retinoids

CABTREO falls under the topical retinoids segment, which is anticipated to register the fastest CAGR over the forecast period. Topical retinoids are widely used to treat various skin conditions, including acne, and their user-friendly packaging and various concentrations make them a preferred choice among patients. The approval of CABTREO, which includes a retinoid, is expected to drive growth in this segment[4].

Regional Market Dynamics

The Asia Pacific region is estimated to register the highest CAGR due to increasing awareness and the entry of more companies into the market. Latin America will witness a stable CAGR driven by the rising prevalence of moderate to severe acne and growing recognition of treatments. North America, however, dominated the market share in 2023 and is expected to remain a significant player[1].

Approval and Regulatory Milestones

CABTREO has received FDA approval in October 2023 and has also been approved by Health Canada. These approvals are crucial for expanding the drug's reach and generating new revenue streams. For instance, the approval in Canada opens up new markets across Canadian pharmacies by Q4 2024[5].

Financial Performance of Bausch Health Companies Inc.

Bausch Health Companies Inc., the developer of CABTREO, has shown robust financial performance in recent quarters. The company reported a first-quarter revenue of $2.15 billion, an 11% increase year-over-year, and an adjusted EBITDA of $665 million, up 13% from the previous year. The Bausch + Lomb segment, which includes dermatological products, saw an 18% revenue increase to $1.099 billion, indicating strong operational performance[2].

Impact on Bausch Health's Financial Trajectory

The approval and launch of CABTREO are expected to contribute significantly to Bausch Health's revenue growth. The company's recent earnings report highlights strong revenue streams, with an operating revenue of $2.4 billion and an EBITDA of $1.03 billion for Q2 2024. The gross profit margin of 70.8% and EBIT margin of 14.5% reflect the company's pricing power and cost management efficiency[5].

Growth Prospects and Strategic Moves

Bausch Health is not only relying on CABTREO for growth but also exploring other strategic moves. The potential sale of the Bausch + Lomb segment could bring in substantial proceeds, enabling the company to repay debt and invest in further business growth. This divestiture is anticipated to bolster the company's financial footing and provide room for future strategic investments[5].

Market Reaction and Stock Performance

The approval of CABTREO has been well-received by the market, with Bausch Health's stock rising by 7.4% following the Health Canada approval. This positive market reaction indicates investor confidence in the company's product pipeline and growth prospects[5].

Competitive Landscape

In the competitive landscape of the acne treatment market, Bausch Health Companies Inc. is among the leading players, along with Allergan and GALDERMA. The launch of CABTREO positions Bausch Health favorably, allowing it to compete more effectively in the market[1].

Economic Implications of Precision Medicines

The development of precision medicines, such as CABTREO, has significant economic implications. These drugs often target smaller patient populations but can generate substantial value and profits due to their unique positioning and lack of generic competition. This shift towards precision medicines can change optimal pricing strategies and the structure of R&D incentives[3].

Key Takeaways

• Market Growth: The global acne treatment market is projected to grow at a CAGR of 5.2% from 2024 to 2032.
• Segment Performance: The topical retinoids segment, where CABTREO belongs, is expected to register the fastest CAGR.
• Regional Dynamics: Asia Pacific and Latin America are key regions for growth, while North America remains a dominant market.
• Financial Performance: Bausch Health Companies Inc. has shown strong revenue and EBITDA growth, with CABTREO expected to contribute significantly.
• Strategic Moves: The potential sale of the Bausch + Lomb segment and the launch of CABTREO are strategic moves to bolster financial strength and growth.

FAQs

Q: What is CABTREO, and how is it used? A: CABTREO is a triple-combination topical treatment for acne vulgaris, approved for patients over 12 years old. It includes a retinoid and is used to treat acne.

Q: Which regions are expected to drive the growth of the acne treatment market? A: The Asia Pacific and Latin America regions are expected to drive significant growth in the acne treatment market.

Q: How has Bausch Health Companies Inc.'s stock performed following the approval of CABTREO? A: Bausch Health's stock rose by 7.4% following the Health Canada approval of CABTREO, indicating positive market reaction.

Q: What are the economic implications of developing precision medicines like CABTREO? A: Precision medicines like CABTREO can generate substantial value and profits due to their unique positioning and lack of generic competition, influencing pricing strategies and R&D incentives.

Q: What are the key financial metrics for Bausch Health Companies Inc. in recent quarters? A: Bausch Health reported a first-quarter revenue of $2.15 billion, an adjusted EBITDA of $665 million, and a gross profit margin of 70.8% in recent quarters.

Sources

1. Fortune Business Insights: Acne Treatment Market Size, Trends | Revenue Share [2032]
2. GuruFocus: Bausch Health Companies Inc Reports Q1 2024 Earnings: A Detailed Analysis Compared to Analyst Estimates
3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market
4. Grand View Research: Acne Drugs Market Size, Share And Trends Report, 2030
5. Timothy Sykes: Why Bausch Health Companies Inc Stock is Surging?