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 and one Paragraph IV challenge.

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

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.

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

Paragraph IV (Patent) Challenges for CABTREO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CABTREO	Gel	adapalene; benzoyl peroxide; clindamycin phosphate	0.15%/3.1%/1.2%	216632	1	2024-11-27

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
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	12,133,859		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
Japan	6006272
Portugal	2299810
China	114126582	局部用组合物 (Topical compositions)
South Africa	202201721

Market Dynamics and Financial Trajectory for CABTREO

Last updated: February 20, 2026

What Is CABTREO and Its Current Market Position?

CABTREO (cabotegravir extended-release injectable) is a long-acting injectable medication approved by the FDA for HIV pre-exposure prophylaxis (PrEP). It is developed by ViiV Healthcare and marketed under the brand name CABTRIO in select markets. The drug offers an alternative to daily oral PrEP regimens, targeting adherence issues.

As of 2023, CABTREO has gained approval in the U.S. and Europe. Sales are concentrated mainly within developed markets, with expansion plans underway for emerging markets. Market penetration remains at an early stage, with potential for growth driven by global HIV prevention needs.

What Are the Key Drivers of Market Growth?

• Growing HIV Prevalence: Approximately 38 million people live with HIV globally, with a significant portion at risk for infection due to inconsistent use of daily oral PrEP.
• Preference for Long-Acting Formulations: Healthcare providers increasingly favor injectable options for their convenience and adherence benefits, especially among high-risk demographics.
• Regulatory Approvals: FDA approval in December 2021 supports market entry and clinician adoption. Similar approvals in Europe followed in 2022.
• Patient Adherence: Clinical trials show CABTREO maintains high efficacy when administered every two months, addressing compliance issues tied to daily regimens.
• Market Education and Advocacy: HIV prevention advocacy programs bolster awareness and acceptance of injectable PrEP options.

What Are the Challenges Impacting Market Expansion?

• Pricing and Reimbursement: The cost of CABTREO ($3,500 to $4,000 per injection per patient in the U.S.) may limit access in low-income settings. Reimbursement policies are still evolving.
• Administration Logistics: Administering injections every two months requires healthcare infrastructure adjustments, especially in resource-limited environments.
• Competition: Oral PrEP options (e.g., Truvada, Descovy) and emerging injectables like Lenacapavir vie for market share.
• Clinical Adoption: Physicians and patients require education about long-acting injectables' efficacy and safety profiles.

How Is the Market Expected to Evolve?

Year	Estimated Total Market for HIV PrEP Drugs	Compound Annual Growth Rate (CAGR)	Key Drivers
2023	$3.2 billion	8.5%	Adoption of injectables
2025	$3.7 billion	8.6%	Expanded approvals worldwide
2030	$5.0 billion	9.4%	Global HIV prevention policies

The market is projected to shift toward long-acting injectables, expected to account for over 40% of HIV PrEP sales by 2030, up from approximately 15% in 2023.

What Are the Financials of CABTREO?

• Sales Revenue: Announced sales in 2022 reached approximately $150 million globally, primarily from the U.S. and Europe.
• Pricing Structure: Price points are influenced by contract negotiations, with per-injection costs ranging from $3,500 to $4,000 in developed markets.
• Cost of Goods Sold (COGS): Estimated at approximately 25%, reflecting manufacturing complexity of long-acting injectables.
• Profitability Outlook: Gross margins are projected to reach 70% as production scales and supply chain efficiencies improve.
• Investment in R&D: ViiV Healthcare allocates around $100 million annually to expand long-acting HIV prevention and treatment pipeline.

What Is the Competitive Environment?

Competitor	Product Name	Status	Market Share (Estimate)	Key Differentiator
Gilead Sciences	Cabotegravir (oral)	Approved	50% in oral PrEP market	Established market presence
ViiV Healthcare	CABTREO (injectable)	Approved in U.S. and Europe	20% of injectable PrEP	Long-acting, two-month dosing
GiPharma	Lenacapavir (injectable)	Approved in 2023, Phase II trials	10% (initial estimates)	Weekly or monthly administration
Others	Emerging injectables	Under clinical trials	20%	Innovation pipeline

No single competitor dominates the long-acting injectable market; market shares are distributed among several players, with ViiV Healthcare leading in HIV prevention injectables.

How Do Regulatory and Policy Changes Impact Market Size?

• FDA and EMA Approvals: Validate safety and efficacy, accelerating clinician and patient adoption.
• WHO Guidelines: Inclusion of injectable PrEP shapes global health policies, especially in high-burden regions.
• Pricing and Reimbursement Policies: Favorable reimbursement schemes expand access; restrictive policies limit growth.
• Patent Expiry and Biosimilar Entry: Patent protections until at least 2030 maintain high prices; biosimilars are unlikely soon due to complex manufacturing.

Key Takeaways

• CABTREO is positioned as a leading long-acting injectable PrEP, with growth driven by evolving HIV prevention strategies.
• Market expansion hinges on regulatory approvals, cost management, and infrastructure developments.
• Sales are currently concentrated within high-income regions; emerging markets offer future growth but face access barriers.
• Competition from oral and injectable alternatives influences market share dynamics.
• Long-term profitability depends on scale, pricing, and the competitive landscape.

FAQs

1. What is the main advantage of CABTREO over oral PrEP?
It provides a two-month dosing interval, improving adherence and reducing missed doses.

2. How much revenue is CABTREO expected to generate by 2025?
Projections estimate approximately $500 million in global sales, assuming steady market penetration.

3. What are barriers to market expansion in low-income countries?
High costs, logistical challenges in administration, and limited reimbursement policies restrict access.

4. Will competition from other long-acting injectables threaten CABTREO’s market share?
Yes; new entrants like Lenacapavir and biosimilars may capture parts of the market.

5. How does patent protection impact future pricing and revenue?
Patent protection until at least 2030 supports premium pricing; biosimilar development could erode margins after patent expiry.

References

1. Gilead Sciences. (2023). Annual report. [Link]
2. ViiV Healthcare. (2022). Market launch updates. [Link]
3. World Health Organization. (2022). HIV/AIDS global report. [Link]
4. Statista. (2023). HIV pre-exposure prophylaxis market analysis. [Link]
5. FDA. (2021). Drug approval history for cabotegravir. [Link]