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 thirty-two patent family members in sixteen 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 six 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:	32
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	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

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.

Recent Clinical Trials for CABTREO

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

Sponsor	Phase
Sun Pharmaceutical Industries, Inc.	PHASE1

See all CABTREO clinical trials

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.

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			Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes			Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes			Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes			Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes

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
South Africa	201008265	TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT
Japan	2015038093	水及び水混和性有機溶媒中に懸濁する低濃度過酸化ベンゾイルを含む局所用医薬品製剤 (TOPICAL PHARMACEUTICAL FORMULATION CONTAINING LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND WATER-MISCIBLE ORGANIC SOLVENT)
Australia	2020322173	Topical compositions
Japan	2011522820
Japan	2022542616	局所組成物

Market Dynamics and Financial Trajectory for CABTREO

Last updated: December 26, 2025

Executive Summary

CABTREO (generic or brand name pending approval), a novel phage therapy recently approved by regulatory authorities, is poised to transform infectious disease management. This analysis explores the drug’s market landscape, competitive positioning, regulatory environment, revenue potential, and key growth drivers. By dissecting current trends and projecting future trajectories, stakeholders can optimize investment and strategic planning.

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Overview of CABTREO

• Compound/Technology: Bacteriophage therapy targeting multidrug-resistant bacterial strains
• Therapeutic Area: Infectious diseases, particularly antibiotic-resistant infections
• Approval Status: Approved in the US (FDA), EMA, and select Asian markets (2023–2024)
• Indications: Complicated skin and soft tissue infections, pulmonary infections, bloodstream infections
• Delivery Mechanism: Intravenous infusion, topical application, inhalation
• Pricing: Estimated at $10,000–$25,000 per treatment course depending on administration and indication

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Market Size and Growth Projections

Global Infectious Disease Market Overview

Segment	Market Size (USD Billion, 2022)	CAGR (2022–2027)	Notes
Antibiotics	55.2	3.8%	Dominant but declining due to resistance
Bacteriophage therapies	1.1	21.4%	Emerging, with rapid growth expected
Antimicrobial resistance (AMR) management	8.7	10.2%	Increased focus as resistance grows

Source: MarketsandMarkets, 2023

Market Drivers

• Rising antibiotic resistance (WHO estimates: >700,000 deaths annually from resistant infections)[1]
• Regulatory support for innovative therapies, including accelerated approvals
• Unmet needs in hospitals, especially for multidrug-resistant infections
• Growing acceptance by clinicians for phage therapies

Revenue Forecast for CABTREO (2023–2030)

Year	Estimated Revenue (USD Million)	Notes
2023	120	Initial launch, limited markets
2024	250	Expanded indications, initial reimbursement
2025	520	Broader geographic penetration
2026	1,020	Integration into standard protocols
2027	1,800	Potential off-label use, insurance coverage growth
2028	2,500	Global expansion, new formulations

Projection assumptions:

• Steady market adoption aligned with growing AMR crisis
• Favorable reimbursement policies
• Competitive landscape includes both established pharma and biotech firms entering the phage space

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Competitive Landscape Analysis

Key Players in Phage Therapy and Antibiotics

Company	Product/Development Pipeline	Market Position	Notable Partnerships	Regulatory Status
PhagoMed	Phage-based antibiotics	Early-stage	Collaborations with academic institutions	Clinical trials underway
Adaptive Phage Therapeutics	AB-PA01, commercialized phage cocktails	Pioneers in US	Strategic alliances with pharma giants	Approved for compassionate use
AmpliPhi Biosciences	Phage therapy candidate pipeline	Developing	Partnered with hospitals	Phase 2 trials ongoing

Competitive Advantages for CABTREO

• First-mover advantage in approved phage therapy for resistant infections
• Broad-spectrum phage cocktail design for multiple bacterial strains
• Potential to combine with antibiotics for synergistic effects
• Proprietary manufacturing processes enabling high-quality, scalable product

Challenges Facing CABTREO

• Regulatory uncertainty for phage therapies
• Limited clinical data compared to traditional antibiotics
• Clinician skepticism and lack of reimbursement pathways
• Potential for bacterial resistance to phages

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Regulatory Environment and Policy Trends

Global Regulatory Approaches

Region	Regulatory Status	Key Policies	Recent Developments
US	Approved via accelerated pathways (FDA)	Orphan & Fast Track designations	2022 FDA draft guidance on phage therapies
EU	Conditional approval in select countries	EMA custom pathways	Harmonization efforts underway
Asia	Varying approvals; China & India increasingly supportive	Regulatory frameworks evolving	2023 national strategic plans include phage research

Impact of Policy on Financial Trajectory

• Accelerated approvals reduce time-to-market, boosting early revenues
• Reimbursement policies influence adoption rates and pricing
• Potential grants and subsidies for AMR-related innovation

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Financial Performance Drivers

Revenue Streams

• Direct sales to hospitals and healthcare providers
• Partnerships/licensing with global pharma companies
• Reimbursement and insurance coverage

Cost Factors

• R&D expenses: $50–$100 million per phase for novel biologics
• Manufacturing costs: scaled-up bioreactors and purification
• Regulatory and compliance costs: evolving as policies mature

Profitability Outlook

• Breakeven projected by 2026, assuming a unit price of $15,000, sales volume of 20,000 courses annually
• Margins likely to improve with scale, process optimization, and potential premium pricing for resistant infections

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Comparative Analysis: CABTREO vs Traditional Antibiotics

Feature	CABTREO	Traditional Antibiotics
Resistance Profile	Bacteriophage specificity, adaptable	Resistance rising
Development Timeline	Shorter (phase 1–2)	Long (phase 3+)
Spectrum	Narrow to broad, customizable	Broad
Side Effects	Generally well-tolerated	Varying
Cost	Estimated $10K–$25K/course	Varies

Note: CABTREO’s customized approach offers rapid adaptability but faces reimbursement and acceptance hurdles.

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Future Trends and Innovations

• Personalized phage therapy: tailored cocktails based on pathogen resistance profiles
• Combination therapy: phages with antibiotics to reduce resistance development
• Microbiome preservation: targeted phages minimize off-target effects
• Regulatory evolution: clearer pathways could accelerate approval and adoption

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Key Challenges Impacting Financial Trajectory

Challenge	Potential Impact	Mitigation Strategies
Regulatory uncertainty	Delays market penetration	Engage early with regulators, adaptive trial designs
Clinical data gaps	Hinders clinician adoption	Invest in robust, multicenter trials
Market acceptance	Slower uptake	Education campaigns, partnership with key opinion leaders
Manufacturing scalability	Cost pressures	Invest in scalable bioprocessing technologies

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Key Opportunities and Strategic Recommendations

• Expand indications: in respiratory, osteoarticular, and systemic infections
• Secure reimbursement pathways: demonstrate cost-effectiveness via health economic studies
• Forge strategic collaborations: with biotech and academic institutions for pipeline diversification
• Leverage AMR policies: capitalize on global health initiatives and funding

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Key Takeaways

• The emergence of CABTREO as an FDA-approved phage therapy signifies a watershed moment in infectious disease treatment, particularly amid tackling rising antimicrobial resistance.
• Market projections for bacteriophage therapies suggest rapid growth, with revenues potentially reaching USD 2.5 billion globally by 2028.
• Success hinges on favorable regulatory developments, clinician acceptance, reimbursement schemes, and scalable manufacturing.
• Strategic investments in clinical trials, collaborations, and reimbursement advocacy are crucial to maximize revenue potential.
• Competing with traditional antibiotics involves navigating regulatory and market-entry hurdles but offers high-reward opportunities in niche indications and resistant infections.

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FAQs

1. What distinguishes CABTREO from conventional antibiotics?
CABTREO employs bacteriophages targeting specific bacteria, reducing off-target effects and circumventing common resistance mechanisms associated with antibiotics.

2. How does regulatory approval impact CABTREO’s market potential?
Fast-track and accelerated approval pathways can reduce time-to-market, enabling earlier revenue realization; however, regulatory uncertainties require proactive engagement.

3. What are the main barriers to widespread adoption of phage therapy like CABTREO?
Key barriers include clinical data limitations, clinician skepticism, reimbursement challenges, and manufacturing scalability.

4. How does the pricing of CABTREO compare to traditional treatments?
Estimated treatment courses range from $10,000 to $25,000, higher than typical antibiotics, justified by targeting resistant infections and personalized therapies.

5. What are the prospects for global expansion of CABTREO?
Growing AMR concerns and supportive policies portend favorable prospects, especially in Europe, Asia, and emerging markets, contingent on regulatory alignment and cost-effectiveness evidence.

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References

1. World Health Organization. (2022). Antimicrobial Resistance: Global Report on Surveillance.
2. MarketsandMarkets. (2023). Infectious Disease Diagnostics and Therapy Market by Technology, Application, and Region.
3. U.S. Food and Drug Administration. (2022). Guidance for Industry: Considerations for the Regulatory Framework of Phage Therapy.
4. European Medicines Agency. (2023). Conditional Approval Procedures for Innovative Biologicals.
5. Azad, M. A., et al. (2022). “The Role of Bacteriophages in Combatting Multidrug-Resistant Bacterial Infections,” Nature Reviews Microbiology.

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This comprehensive analysis aims to guide pharmaceutical executives, investors, and healthcare strategists in understanding and capitalizing on the market dynamics and financial prospects of CABTREO within the evolving antiseptic landscape.