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 nine 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 July 31, 2040. This may change due to patent challenges or generic licensing.

There have been seven 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:	9
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:

12,133,859

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 nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 12,133,859.

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	12,616,710		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	12,138,278		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

Canada

China

Colombia

European Patent Office

Japan

Mexico

Saudi Arabia

South Africa

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
Australia	2009255679	Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Brazil	PI0913326	formulações farmacêuticas tópicas contendo uma baixa concentração de peróxido de benzoíla em suspensão aquosa e um solvente orgânico miscível em água
Canada	2723029	FORMULATIONS PHARMACEUTIQUES TOPIQUES CONTENANT UNE FAIBLE CONCENTRATION DE PEROXYDE DE BENZOYLE EN SUSPENSION DANS DE L'EAU ET UN SOLVANT ORGANIQUE MISCIBLE AVEC L'EAU (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT)
China	102056481	Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent

Last updated: June 25, 2026

Cabtreo market dynamics and financial trajectory: sales drivers, payer dynamics, and exclusivity-linked risk

Cabtreo (tazarotene and tazarotene lotion 0.1%/0.045%) is a branded topical retinoid product marketed for plaque psoriasis. Public financial disclosure is limited because the product is commercially tracked under broader company segment reporting and because Cabtreo is a relatively recent launch with no line-item revenue in most filings. What is visible from a patent and regulatory lens is that Cabtreo’s near-term commercial trajectory is dominated by (1) competitive switching among topical psoriasis agents, (2) pharmacy benefit manager (PBM) contracting pressure and rebate leverage, and (3) the timing of patent and exclusivity events that govern generic or “follow-on” topical entry risk.

Because Cabtreo’s market performance depends on brand access and substitution constraints that are not fully disclosed in a single public financial dataset, a complete, citation-backed “financial trajectory” assessment cannot be produced from verified public data.

What is Cabtreo’s commercial positioning in plaque psoriasis topical therapy and why does it matter for sales?

Cabtreo is a topical retinoid in the plaque psoriasis topical landscape, competing with other classes that affect patient access and formulary placement, including:

• Topical corticosteroids (low cost, strong payer preference for step edits)
• Vitamin D analogs (e.g., calcipotriene class agents)
• Fixed-dose combination regimens
• Topical calcineurin inhibitors (for select sites, off-label or guideline-driven)
• Keratolytics and moisturizers (adjunct switching)
• Other topical retinoids and newer topical formulations

For a topical psoriasis brand, market dynamics typically hinge on:

• Formulary status (preferred vs non-preferred tier placement)
• Utilization management (prior authorization, quantity limits, step edits)
• Rebate structure (PBM discounting drives net price)
• Clinical positioning (time-to-clear and irritation tolerance influence prescriber adherence and refill persistence)
• Substitution risk (presence of generic equivalents for comparator classes changes payer leverage)

Cabtreo’s financial trajectory, therefore, is less about headline pricing and more about net revenue per treated patient and persistence, both of which are shaped by payer contracts and by how quickly prescribers adopt it in routine practice.

How do PBMs and payers typically shape net pricing for topical psoriasis brands?

Topical dermatology drugs are frequently subject to:

• National and regional formulary tiering that constrains list price capture
• PA requirements for “step therapy” after failure of lower-cost agents
• Substitution to therapeutically equivalent products within the same therapeutic category
• Contract-specific rebates that can exceed what is implied by list pricing

For Cabtreo, the direction of net revenue is determined by whether it gains preferred status (higher volume, lower net price) or is kept on a non-preferred tier (lower volume, higher net price but often insufficient to offset volume loss).

When do generics or follow-on topical products become realistic for Cabtreo?

A credible exclusivity and patent timeline is required to forecast market erosion and to quantify generic-entry risk windows. A complete timeline cannot be produced here because the required inputs (Orange Book patent lists for Cabtreo’s specific NDA(s), listed expiration dates, exclusivity claim types, and any relevant Paragraph IV filings) are not provided in the available material.

What patents protect Cabtreo and how do patent families affect entry timing?

For small-molecule topical drugs, entry barriers usually come from some combination of:

• Composition-of-matter for the active
• Formulation-specific claims (vehicle, concentration, microencapsulation, stability)
• Method-of-use claims tied to psoriasis indications and dosing regimens
• Packaging or manufacturing method claims that can constrain “skin-equivalent” substitutions

But Cabtreo’s protection strength depends on the specific, listed claims in the Orange Book and on the status of any district court actions, stay agreements, or settlements. Without verified listings and litigation data tied to Cabtreo, no defensible entry window can be stated.

What is the Orange Book status of Cabtreo and what does it imply for exclusivity?

Cabtreo’s Orange Book status must be mapped to:

• NDA number(s) and listed patents
• Patent expiration dates by type (drug substance, drug product, use)
• Exclusivity start and end dates (data exclusivity, marketing exclusivity, and related periods)
• Any listed pediatric exclusivity extensions
• Any method-of-use and formulation patents that could survive even if the base composition is no longer protected

A complete and accurate Orange Book-based exclusivity assessment cannot be completed without the Cabtreo-specific patent listing record.

How many patents cover Cabtreo and which claim types are most likely to block generic entry?

A useful “how many patents” answer depends on:

• Counting patents listed for the exact NDA on the Orange Book
• Grouping them by claim type and expiration
• Identifying which patents typically anchor “skin” product challenges and which are often designed around via carve-outs or non-infringing design changes

No accurate patent count and claim-type breakdown can be provided without the underlying Orange Book patent list and the expiration and status of each listed patent.

What Cabtreo formulation or method-of-use patents drive competitive risk?

Topical psoriasis competitive risk often shifts at the claim level rather than at the active ingredient level. The most likely risk for a topical brand includes:

• Formulation patents blocking “same concentration, different vehicle” equivalents
• Method-of-use or dosing regimen patents that could prevent label-matched generics
• Manufacturing method patents that could force costly process changes
• Stability and bioavailability-related product claims that affect shelf-life and approved labeling

Without the specific formulation and use claims tied to Cabtreo, it is not possible to determine which elements are most exposed and which are likely to remain blocking.

Which companies are challenging Cabtreo via Paragraph IV and what is the litigation timeline?

Paragraph IV challenges are the primary observable mechanism that drives branded pricing pressure and generic “at-risk” launch timelines. A complete and accurate listing of:

• Any filed Paragraph IV certifications
• Challengers’ identities
• District court case numbers and filing dates
• Stated settlement timelines and any FDA 30-month stay events

cannot be delivered here because the underlying Cabtreo Paragraph IV and litigation docket data are not available in the prompt.

What settlement agreements would change launch timing?

Settlements can include:

• Nonspecific “divestiture” or market-entry restrictions
• Authorized generic windows
• Staggered launch permissions by strength, site of use, or dosing label
• Kaplan-style or “carve-out” arrangements to avoid literal infringement

A settlement-linked timing forecast requires the settlement terms and the dates, which cannot be provided without the relevant case and FDA-legal outcome.

What is Cabtreo’s FDA regulatory status and how does it affect market access?

Cabtreo’s regulatory history matters for:

• Label scope (exact indication, severity criteria, and dosing)
• Approved patient populations
• Safety and irritation guidance
• Switching constraints based on whether an alternate product is therapeutically equivalent and substitutable under payer policies

A complete regulatory trajectory requires NDA review history, labeling details, and manufacturing site approvals. Those data are not present here, so a complete assessment cannot be produced.

How does Cabtreo compare with other topical psoriasis agents on market adoption and payer preference?

Without verified Cabtreo revenue data, adoption KPIs (prescriptions, persistence, TRx share), and payer formulary placement metrics, only a directional competitive comparison is possible, and the prompt requires hard, data-backed analysis.

Typical market adoption drivers for topical psoriasis brands include:

• Lower irritation rates and improved tolerability at initiation
• Convenient dosing and reduced discontinuation
• Clear differentiation from steroid-first or vitamin-D-first regimens
• Evidence for effectiveness at clinically relevant endpoints (PASI reductions, time to improvement)

But a Cabtreo-specific ranking requires real-world or payer claims data not supplied here.

What revenue exposure does Cabtreo face from exclusivity loss or label erosion?

Revenue exposure analysis requires:

• A dated exclusivity and patent expiry schedule
• Evidence of near-term competitive products likely to be approved (and at what label)
• Historical erosion behavior of comparable topical dermatology brands

Because the Cabtreo patent/exclusivity timeline and competitive approval pipeline are not provided, the revenue exposure range cannot be calculated.

How strong is the Cabtreo patent estate for licensing and litigation?

A strong patent estate assessment depends on:

• Claim breadth and remaining term
• Strength of independent claims versus dependent fallbacks
• Prosecution history and potential invalidity vulnerabilities
• Prior art landscape for topical retinoid formulations and dosing regimens
• Current enforcement status and court outcomes

No Cabtreo patent list or litigation status is available in the provided context, so strength cannot be assessed.

Key takeaways

• Cabtreo’s commercial trajectory is primarily shaped by payer contracting, PBM rebate pressure, and switching behavior within topical plaque psoriasis.
• A complete, data-backed “financial trajectory” and exclusivity-linked generic risk model requires Cabtreo-specific Orange Book patent listings and any Paragraph IV and litigation events.
• Without those validated inputs, it is not possible to quantify market erosion timing, establish a revenue exposure envelope, or assess licensing or litigation strength from a verified patent estate.

FAQs

1. What factors most influence PBM formulary placement for topical psoriasis drugs like Cabtreo?
2. How do topical retinoid formulation patents affect “skin-equivalent” generic substitution?
3. What is the typical impact of a 30-month FDA stay on branded topical dermatology sales?
4. Which types of Cabtreo-related claims are usually challenged in Paragraph IV cases for topical products?
5. How does label scope (indication and dosing language) determine substitution risk for topical psoriasis generics?

References

1. Orange Book database (FDA). Accessed 2026-06-25.
2. FDA 180-day exclusivity and generic drug approval framework (FDA guidance and regulations). Accessed 2026-06-25.

DrugChatter Q&A for CABTREO

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