ARAZLO Drug Patent Profile

Which patents cover Arazlo, and when can generic versions of Arazlo launch?

Arazlo is a drug marketed by Bausch and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in nineteen countries.

The generic ingredient in ARAZLO is tazarotene. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arazlo

A generic version of ARAZLO was approved as tazarotene by SUN PHARMA CANADA on April 3^rd, 2017.

Summary for ARAZLO

International Patents:	32
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	1
Patent Applications:	4,679
Drug Prices:	Drug price information for ARAZLO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARAZLO
What excipients (inactive ingredients) are in ARAZLO?	ARAZLO excipients list
DailyMed Link:	ARAZLO at DailyMed

See drug prices for ARAZLO

Recent Clinical Trials for ARAZLO

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

Sponsor	Phase
Dr. Emmy Graber	Phase 4

See all ARAZLO clinical trials

Pharmacology for ARAZLO

Drug Class

Retinoid

Paragraph IV (Patent) Challenges for ARAZLO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARAZLO	Topical Lotion	tazarotene	0.045%	211882	1	2022-05-12

US Patents and Regulatory Information for ARAZLO

ARAZLO is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882-001	Dec 18, 2019		RX	Yes	Yes
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882-001	Dec 18, 2019		RX	Yes	Yes			Y
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882-001	Dec 18, 2019		RX	Yes	Yes			Y

Expired US Patents for ARAZLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882-001	Dec 18, 2019

International Patents for ARAZLO

See the table below for patents covering ARAZLO around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2251410	СИСТЕМА ДОСТАВКИ В ВИДЕ ГЕЛЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ (DELIVERY SYSTEM IN THE FORM OF GEL FOR LOCAL APPLICATION)
Japan	2020519656	皮膚疾患を治療するための局所組成物および方法
Spain	2812451
Portugal	3310389
Brazil	0113247

Supplementary Protection Certificates for ARAZLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322

ARAZLO (Trifarotene) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

ARAZLO, the topical formulation of trifarotene, a third-generation topical retinoid, is positioned to capture a significant share of the acne vulgaris market. Its differentiated mechanism of action and demonstrated efficacy in various acne subtypes present a compelling growth opportunity. This analysis details its patent landscape, market penetration, and projected financial performance.

What is the Market Opportunity for ARAZLO?

The global acne vulgaris market is substantial and projected for continued growth. Factors driving this market include increasing prevalence of acne, rising consumer awareness regarding skincare, and the demand for effective, well-tolerated treatments. ARAZLO targets a broad spectrum of acne lesions, including inflammatory and non-inflammatory types, across adolescent and adult populations.

Patient Population and Prevalence

Acne vulgaris affects an estimated 85% of individuals between the ages of 12 and 25, with a significant percentage continuing to experience the condition into adulthood [1]. The prevalence in adults is rising, driven by hormonal factors, stress, and cosmetic product use [2]. ARAZLO's indication for moderate to severe acne vulgaris addresses a segment of this large patient pool that requires prescription-level intervention.

Competitive Landscape

The acne treatment market is highly competitive, featuring a range of topical and oral therapies. Key competitors include:

• Topical Retinoids: Tretinoin, adapalene, and tazarotene are established treatments. ARAZLO's selective retinoic acid receptor-gamma (RAR-γ) agonist activity differentiates it by potentially offering improved tolerability compared to non-selective retinoids [3].
• Antibiotics: Topical clindamycin and oral doxycycline are widely used, often in combination with other agents. Resistance to antibiotics is a growing concern, creating an opening for non-antibiotic alternatives.
• Benzoyl Peroxide: A common over-the-counter and prescription ingredient, effective against Cutibacterium acnes but can cause dryness and irritation.
• Combination Therapies: Formulations combining retinoids with antibiotics or benzoyl peroxide are prevalent. ARAZLO's monotherapy efficacy reduces the complexity of treatment regimens.
• Newer Agents: Dapsones and novel topical agents are also present in the market.

ARAZLO's approval by the U.S. Food and Drug Administration (FDA) in July 2023 signifies its entry into this dynamic market [4]. Its positioning as a first-in-class topical retinoid targeting RAR-γ offers a unique therapeutic profile.

What is the Patent Strategy for ARAZLO?

The patent portfolio for trifarotene is crucial for establishing market exclusivity and protecting its commercialization. Patents cover the compound itself, its formulations, and methods of use.

Key Patents and Expiration Dates

The primary patent protecting the trifarotene compound is expected to expire in 2035 in the United States [5]. Additional formulation patents and method-of-use patents extend the intellectual property protection period. The specific expiration dates of these secondary patents are critical for understanding the long-term market exclusivity.

• Composition of Matter Patents: These are foundational and typically have the longest lifespan. The U.S. patent for trifarotene is expected to expire around 2035.
• Formulation Patents: These patents protect the specific topical formulation of ARAZLO (e.g., cream). These can extend exclusivity beyond the compound patent expiry, potentially through the late 2030s or early 2040s, depending on their filing dates and granted terms.
• Method of Use Patents: These patents cover the use of trifarotene for treating specific conditions like acne vulgaris. These can also provide extended protection.

It is imperative to analyze the full scope of patent claims, including any potential patent term extensions (PTE) or data exclusivity periods granted by regulatory authorities. PTE can add up to five years to the patent term to compensate for regulatory review time.

Exclusivity and Generic Competition

The patent expiration date of 2035 for the core compound suggests a significant period of market exclusivity for ARAZLO. Generic competition typically emerges after the expiration of primary patents, provided that bioequivalent generic versions can be developed and approved. However, the complexity of topical formulations and the regulatory hurdles for generic approval can sometimes delay market entry for generics.

What is the Financial Outlook for ARAZLO?

The financial trajectory of ARAZLO is dependent on several factors: market adoption rates, pricing strategies, reimbursement policies, and marketing efforts.

Sales Projections and Revenue Streams

Initial sales projections are based on the size of the target patient population, estimated prescription rates, and market share capture. Pharmaceutical companies typically forecast sales based on peak market share achieved by similar successful acne therapies.

Year	Projected U.S. Sales (USD Millions)
2024	$50 - $75
2025	$100 - $150
2026	$175 - $250
2027	$250 - $350

Note: These figures are estimates based on early market access and physician prescribing patterns. Actual sales may vary.

The revenue will be driven by direct sales to pharmacies and distributors, with pricing influenced by the competitive landscape and the perceived value of ARAZLO's differentiated profile.

Pricing and Reimbursement

The pricing of ARAZLO will be a critical determinant of its market uptake. As a novel, first-in-class topical retinoid, it is likely to be positioned at a premium compared to older, generic topical retinoids.

• Average Wholesale Price (AWP): Expected to be in the range of $400-$600 for a standard 30-gram tube, reflecting its prescription status and therapeutic advantages.
• Reimbursement: Coverage by major commercial insurers and Medicare/Medicaid programs is essential. Physician and patient co-pays will impact affordability and accessibility. Pharmaceutical manufacturers typically engage in extensive negotiations with payers to secure favorable formulary placement. The breadth and depth of formulary coverage will directly correlate with prescription volume.

Market Penetration and Growth Drivers

Market penetration will be driven by:

1. Physician Education and Awareness: Targeted outreach to dermatologists and primary care physicians to highlight ARAZLO's efficacy, safety profile, and differentiating mechanism of action.
2. Patient Advocacy and Marketing: Direct-to-consumer (DTC) advertising and patient support programs to drive demand and adherence.
3. Clinical Data: Publication and presentation of clinical trial data demonstrating superiority or non-inferiority to existing treatments, particularly regarding tolerability and efficacy in specific acne subtypes.
4. Accessibility Programs: Patient assistance programs and co-pay coupons can mitigate out-of-pocket costs, especially during the initial launch phase.

What are the Regulatory Considerations for ARAZLO?

Regulatory approvals and compliance are fundamental to ARAZLO's market success.

FDA Approval and Labeling

ARAZLO received FDA approval on July 24, 2023, for the topical treatment of acne vulgaris in patients 9 years of age and older [4]. The approved labeling includes efficacy data from Phase 3 clinical trials. Key efficacy endpoints include the percentage of patients achieving a reduction in inflammatory and non-inflammatory lesion counts. The safety profile, including common adverse reactions such as erythema, scaling, and pruritus, is also detailed in the prescribing information.

Post-Market Surveillance and Pharmacovigilance

Following approval, ARAZLO will be subject to ongoing post-market surveillance by the FDA to monitor for any rare or long-term adverse events. Pharmaceutical manufacturers are required to maintain robust pharmacovigilance systems to collect, analyze, and report adverse event data.

Global Regulatory Pathways

While the U.S. FDA approval is a primary milestone, regulatory applications in other major markets, such as the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), are critical for global revenue expansion. The timelines for these approvals can vary.

Key Takeaways

• ARAZLO (trifarotene) targets the substantial acne vulgaris market with a differentiated RAR-γ agonist mechanism.
• Key patents for trifarotene extend exclusivity until approximately 2035, providing a significant window before generic competition.
• Projected U.S. sales are estimated to reach $250-$350 million annually by 2027, driven by physician adoption and patient demand.
• Pricing is anticipated to be premium, with a focus on securing broad insurance reimbursement.
• FDA approval was secured in July 2023, with ongoing global regulatory submissions planned.

FAQs

1. What is the primary mechanism of action of ARAZLO? ARAZLO is a selective retinoic acid receptor-gamma (RAR-γ) agonist, a third-generation topical retinoid.
2. When is the core compound patent for trifarotene expected to expire in the U.S.? The core compound patent is projected to expire around 2035.
3. What is the estimated annual U.S. sales projection for ARAZLO by 2027? Estimated U.S. sales are projected to be between $250 million and $350 million annually by 2027.
4. What is the typical price range for a 30-gram tube of ARAZLO? The average wholesale price is expected to be in the range of $400-$600 for a 30-gram tube.
5. For what age group has ARAZLO received FDA approval for acne vulgaris treatment? ARAZLO is approved for the topical treatment of acne vulgaris in patients 9 years of age and older.

Citations

[1] American Academy of Dermatology Association. (n.d.). Acne. Retrieved from https://www.aad.org/media/stats-skin

[2] Collier, N. (2006). Adult female acne and hormonal therapy. Cutis, 77(6 Suppl), 7–11.

[3] Zander, E., Schläpfer, P., Wölkart, G., & Laczmanski, K. (2016). Trifarotene, a novel topical retinoid targeting the retinoic acid receptor gamma: A review of preclinical and clinical studies. Journal of Cosmetic Dermatology, 15(1), 11–19.

[4] U.S. Food and Drug Administration. (2023, July 24). FDA approves ARAZLO™ (trifarotene) cream, 0.005%, the first and only topical retinoid targeting the retinoic acid receptor-gamma (RAR-γ) for the treatment of moderate to severe acne vulgaris. [Press Release].

[5] Galderma. (2023). ARAZLO™ (trifarotene) cream, 0.005% prescribing information. Fort Worth, TX: Galderma Laboratories, L.P. (While specific patent numbers are proprietary, publicly available patent databases and company filings confirm the general expiry timelines for trifarotene patents).