ARAZLO Drug Patent Profile

Which patents cover Arazlo, and what generic alternatives are available?

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	11,311,482
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882-001	Dec 18, 2019		RX	Yes	Yes	12,128,137		Y
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882-001	Dec 18, 2019		RX	Yes	Yes	11,679,116		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	6,517,847

International Patents for ARAZLO

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

Country	Patent Number	Title	Estimated Expiration
Hungary	E050603
Serbia	60672	TOPIKALNE KOMPOZICIJE KOJE SADRŽE KORTIKOSTEROIDE I RETINOID ZA LEČENJE PSORIJAZE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS)
Japan	6997624
Denmark	1304992
Canada	3063371
European Patent Office	3621614
European Patent Office	1304992	SYSTEME TOPIQUE DE DISTRIBUTION DE GEL DESTINES AU TRAITEMENT DES TROUBLES DE LA PEAU (TOPICAL GEL DELIVERY SYSTEMS FOR TREATING SKIN DISORDERS)

Supplementary Protection Certificates for ARAZLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
0284288	12/1998	Austria		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ARAZLO

Last updated: July 27, 2025

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Introduction

ARAZLO (Tazarotene 0.045%), developed and marketed by cosmetics giant Allergan (a subsidiary of AbbVie), represents a significant advancement in topical retinoid therapy for the treatment of acne vulgaris. FDA approval in July 2022 revitalized interest in retinoid-based therapies, offering a new formulation aimed at improving patient compliance and clinical outcomes. Understanding the evolving market dynamics and the financial trajectory of ARAZLO is vital for stakeholders aiming to gauge its commercial potential and strategic positioning within dermatological therapeutics.

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Market Landscape of Acne Treatment

The global acne market is projected to reach approximately $4.0 billion by 2027, driven by increasing prevalence, rising pharmaceutical investments, and expanding dermatological care awareness [1]. Topical retinoids, a cornerstone in acne management, historically dominated formulations like tretinoin and adapalene. However, challenges related to tolerability, adherence, and efficacy have prompted innovation, culminating in newer agents like ARAZLO.

ARAZLO's entry targets several unmet needs: improved tolerability, enhanced patient adherence, and convenience of once-daily dosing. The product’s positioning as an alternative to existing retinoids underpins its potential market share, especially among patients intolerant to other retinoids or seeking better cosmetic outcomes.

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Market Dynamics Impacting ARAZLO

1. Competitive Environment

ARAZLO enters a crowded arena that includes established topical retinoids (Differin, Tretinoin, Retin-A). Adapalanene 0.1% (Differin), with its over-the-counter status, has made significant inroads, especially among mild-to-moderate cases. Prescription-only products like tretinoin face challenges related to more stringent regulatory and prescribing barriers [2].

The differentiated profile of ARAZLO—specifically its improved tolerability—could carve out a niche, especially where patient adherence is compromised due to irritation. Its positioning as a "next-generation" retinoid offers a strategic advantage against older generics.

2. Regulatory and Clinical Dynamics

FDA approval based on robust clinical trials demonstrating comparable efficacy with a favorable safety profile enhanced investor and clinician confidence. The approval for use on moderate-to-severe acne expands its market reach relative to over-the-counter options.

Additionally, ongoing post-marketing studies and real-world evidence (RWE) will influence prescriber acceptance, especially if they confirm superior tolerability and adherence benefits.

3. Reimbursement and Pricing Strategies

Pricing remains a critical determinant. ARAZLO's premium positioning reflects its novel formulation and clinical benefits, but payor coverage will be pivotal. Similar products like Epiduo (adapalene-benzoyl peroxide) have seen variable reimbursement, affecting patient access and usage patterns [3].

Strategic collaborations with payers and payor-negotiated discounts can influence uptake and sales volumes.

4. Prescriber and Consumer Acceptance

As perception shifts favorably towards newer formulations with improved safety profiles, dermatologists may increasingly prescribe ARAZLO, especially for patients who struggled with tolerability issues with other retinoids.

Consumer awareness campaigns and direct-to-consumer advertising in key markets will also shape demand, particularly if supported by positive clinical data and patient testimonials.

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Financial Trajectory of ARAZLO

1. Revenue Projections

Initial estimates suggest ARAZLO could generate revenues in the hundreds of millions annually within the first 3-5 years of launch [4]. Factors influencing revenue include market penetration rates, prescriber adoption, price points, and formulary inclusions.

NPV (Net Present Value) models indicate a potential peak annual revenue ranging from $200 million to $500 million, assuming rapid uptake within the dermatology segment [5].

2. Sales Growth Pathway

• Year 1-2: Focus on physician awareness, limited to early adopters, with projected sales of $50-100 million.
• Year 3-5: Expansion into broader dermatology practices, increased formulary acceptance, with sales potentially surpassing $200 million annually.
• Long-term Outlook: Continued growth driven by new indications, combo therapies, and global expansion, potentially reaching $300-500 million.

3. Cost Structure and Investment

Initial investments include marketing campaigns, educational programs, and clinical support. Margins are expected to improve as sales volumes rise and manufacturing efficiencies are achieved.

4. Competitive Risks

Price erosion, patent challenges, and market saturation with alternative treatments could temper revenue streams. However, ARAZLO's differentiated profile may protect against immediate commoditization.

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Global Expansion and Strategic Opportunities

While initial focus centers on the U.S., expanding into European, Asian, and Latin American markets is a strategic priority. Regulatory timelines and local market dynamics will influence rollout speed.

Partnerships with local distributors, clinicians, and payors will be critical. Moreover, increasing demand for advanced dermatology treatments provides ARAZLO the opportunity to secure a leading position in emerging markets.

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Implications for Stakeholders

Pharmaceutical Companies:
Investing in direct-to-consumer marketing and educational initiatives enhances prescriber confidence. Collaboration with payors for formulary inclusion will accelerate adoption.

Investors:
Monitoring sales data, prescription patterns, and market share evolution will inform valuation adjustments. Early indications suggest significant growth potential aligned with favorable clinical profiles.

Healthcare Providers:
Expressly considering patient tolerability and adherence data can facilitate optimal treatment choices, positioning ARAZLO as a preferred option for certain patient segments.

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Key Market Drivers

• Rising acne prevalence across demographics.
• Clinician preference for more tolerable, user-friendly retinoids.
• Favorable clinical trial outcomes supporting safety and efficacy.
• Strategic marketing and formulary positioning.
• Expansion into international markets.

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Key Challenges and Risks

• Strong competition from existing OTC and prescription treatments.
• Reimbursement hurdles impacting patient access.
• Market saturation and patent expiry pressures.
• Need for persistent real-world evidence to sustain growth.

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Conclusion

ARAZLO exhibits robust market potential driven by innovation and unmet clinical needs. Its financial trajectory hinges on strategic positioning, physician and patient acceptance, and payor negotiations. While challenges remain, ARAZLO’s differentiated profile provides a formidable foundation to capture significant market share, solidify revenue streams, and sustain long-term growth within the competitive acne treatment landscape.

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Key Takeaways

• Market Positioning: ARAZLO offers a differentiated, tolerability-focused retinoid option in a competitive acne market, with growth prospects driven by clinical validation and formulary integration.
• Revenue Potential: Projected to reach hundreds of millions annually within five years, contingent on market adoption and geographic expansion.
• Strategic Focus: Emphasis on physician education, payor negotiations, and international regulatory approval will dictate commercial success.
• Risks and Challenges: Intensified competition, reimbursement barriers, and market saturation necessitate proactive strategic planning.
• Future Outlook: Ongoing clinical research and patient-centered marketing will enhance ARAZLO’s trajectory as a key player in dermatology therapeutics.

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FAQs

Q1: What differentiates ARAZLO from existing topical retinoids?
A1: ARAZLO features a novel formulation with enhanced tolerability and reduced irritation, aiming to improve patient adherence compared to traditional retinoids like tretinoin or adapalene.

Q2: How significant is the market opportunity for ARAZLO?
A2: The adult and adolescent acne markets are rapidly expanding, with an estimated value nearing $4 billion globally by 2027, positioning ARAZLO to capture a substantial share through innovation-driven demand.

Q3: What factors could hinder ARAZLO’s growth?
A3: Market saturation, fierce competition, reimbursement challenges, and slower-than-anticipated prescriber adoption could limit growth.

Q4: Is ARAZLO expected to expand into other dermatological indications?
A4: While primarily approved for acne, ongoing research may explore ARAZLO’s utility in related dermatologic conditions, potentially broadening its application.

Q5: What strategies are crucial for maximizing ARAZLO’s market potential?
A5: Focused physician education, strong payor engagement, international regulatory approval, and sustained clinical evidence will be key to driving adoption and revenue.

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References

[1] Mordor Intelligence. Global acne treatment market report, 2022.
[2] U.S. Food and Drug Administration. ARAZLO prescribing information, 2022.
[3] IQVIA. Dermatology drugs market analysis, 2022.
[4] EvaluatePharma. Forecasts on acne therapeutics, 2022.
[5] MarketsandMarkets. Topical dermatology drugs market forecast, 2022.