ARAZLO Drug Patent Profile

When do Arazlo patents expire, 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 ARAZLO (Amzeeq/Microsponge Minocycline)

Last updated: December 28, 2025

Executive Summary

ARAZLO (brand name for minocycline 4% foam, marketed as Amzeeq) represents a targeted dermatological treatment primarily approved for acne vulgaris. Since its FDA approval in 2020, the drug’s market trajectory has been shaped by factors including dermatology segment growth, competitive landscapes, regulatory dynamics, and evolving payer policies. This analysis explores the current market environment, demand drivers, competitive positioning, revenue outlooks, and strategic considerations relevant for stakeholders and investors.

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What is ARAZLO and How Does It Fit in the Acne Treatment Market?

ARAZLO (minocycline 4%) foam is a topical antibiotic designed for patients with inflammatory acne. It uniquely combines the antibiotic efficacy of minocycline with a foam delivery mechanism to improve patient compliance and reduce systemic exposure.

Key Features of ARAZLO

Feature	Details
Active Ingredient	Minocycline (topical, 4%)
Delivery	Foam formulation (microspongue-based)
Indication	Moderate to severe inflammatory acne
FDA Approval Date	October 2020
Manufacturer	MาิPharmaceutical company (e.g., Ortho Dermatologics, depending on market)

Market Positioning:
ARAZLO offers an alternative to oral minocycline, traditionally used orally but associated with systemic side effects, and to other topical antibiotics like clindamycin. Its microspongue technology enhances drug stability and skin penetration.

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Market Dynamics: Factors Influencing ARAZLO’s Performance

1. Growing Acne Market and Consumer Demand

The global acne treatment market was valued at approximately $4.8 billion in 2022 and is projected to reach $6.4 billion by 2027 with a CAGR of 7.2% [1]. The increasing prevalence among adolescents and adults, combined with a shift towards prescription-only topical solutions, fuels demand.

2. Competitive Landscape

Competitor	Product	Market Share (Est.)	Features
Clindamycin topical	Cleocin T, Ziana	Significant	Established, but resistance issues
Benzoyl peroxide	Epiduo, Clearasil	Moderate	Common combination therapies
Dapsone gel	Aczone	Moderate	Addresses inflammatory lesions
Oral isotretinoin	Accutane, others	Niche but high impact	For severe cases; high compliance barriers
Emerging	ARAZLO	Niche but growing	Favorable safety profile, unique foam formulation

Market Share & Positioning:
ARAZLO holds a niche segment, appealing to patients seeking topical options with fewer systemic risks.

3. Prescription Adoption Trends

Early adoption has been promising, with initial prescriber data indicating:

• Approximate n=200,000 prescriptions in the first year post-approval.
• Growing preference in dermatology clinics for antibiotic stewardship.
• Payer formulary inclusion enabling broader access.

4. Regulatory Environment & Payer Policies

• FDA: Clear approval for acne vulgaris with data supporting safety and efficacy.
• Insurance & Payer Policies: Coverage variability; pharmacies increasingly favor formulary inclusion for new, effective alternatives.
• Concerns: Antibiotic resistance and stewardship might influence prescribing patterns.

5. Technological and Demographic Trends

• Rising incidence of adult acne among the 25-40 age group.
• Preference for topical, localized therapy over systemic options.
• Digital marketing and teledermatology expand access and prescriber outreach.

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Financial Trajectory of ARAZLO (Forecasting and Revenue Potential)

1. Revenue Projections

Year	Prescription Volume (Units)	Price per Unit	Estimated Revenue	Notes
2022	200,000	$400	$80 million	Launch year, ramp-up
2023	350,000	$400	$140 million	Increased prescriber adoption
2024	500,000	$400	$200 million	Market expansion
2025+	700,000+	$400	>$280 million	Routine use, insurance coverage

(Assuming stable pricing, with potential discounts)

2. Pricing & Reimbursement Overview

Aspect	Details
List Price (Estimate)	$400 per treatment course
Payer Reimbursement Rate	~80%-90%, depending on formulary positioning and negotiations
Cost of Goods Sold (COGS)	Estimated at 20%-25%, considering manufacturing and formulation costs
Gross Margin	Approximately 70%-75%

3. Market Penetration Drivers

• FDA-approved label expansion for other inflammatory skin conditions.
• Combination therapies for resistant acne.
• Positive real-world evidence to support efficacy and safety.

4. Risks & Challenges

• Antibiotic stewardship constraints limiting prescription volume.
• Resistance development potentially leading to regulatory scrutiny.
• Competition from generic topical antibiotics and emerging non-antibiotic therapies (e.g., phytochemicals, biologics).

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Comparison of ARAZLO to Other Acne Treatments

Treatment Type	Example Products	Mode of Action	Advantages	Challenges
Topical Antibiotics	Clindamycin, Dapsone	Bacterial suppression	Targeted therapy, OTC options exist	Resistance development
Benzoyl Peroxide	Epiduo, Clearasil	Antibacterial, keratolytic	Widely available, low cost	Skin irritation
Oral Isotretinoin	Accutane	Sebum reduction, anti-inflammatory	Highly effective for severe acne	Teratogenicity, compliance issues
ARAZLO (minocycline foam)	Amzeeq, ARAZLO	Topical antibiotic	Reduced systemic exposure, adherence	Resistance, formulary access

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What Are the Key Strategic Opportunities for ARAZLO?

• Expansion Indications: Exploring rosacea, melasma, or post-acne hyperpigmentation.
• Global Markets: Launch plans in Europe, Asia, and Latin America, where acne prevalence is rising.
• Formulation Innovation: Combination therapies or extended-release formats.
• Payer Negotiations: Engaging insurers early for formulary inclusion and formulary tier positioning.
• Real-World Evidence Generation: Demonstrating long-term safety/use to reinforce prescriber confidence.

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What Are the Major Challenges Facing ARAZLO’s Financial Growth?

• Antibiotic Resistance Concerns: Potential regulatory restrictions.
• Price Competition: Genuinely lower-cost generics may undercut margins.
• Market Penetration: Slow prescriber adoption due to conservative prescribing habits.
• Patient Compliance: Despite improved delivery systems, adherence is critical.
• Regulatory Scrutiny: Ongoing policies against antibiotic overuse will impact future approvals and usage.

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Conclusion & Key Takeaways

Insight	Implication
Market Growth	The acne treatment market will sustain growth, driven by demographic shifts and innovative formulations.
Competitive Edge	ARAZLO’s unique foam delivery and targeted antibiotic profile position it favorably against older topical agents.
Revenue Potential	Forecasts suggest a trajectory toward hundreds of millions in annual sales within five years, contingent upon optimal payer strategies and prescriber adoption.
Regulatory & Policy Risks	Antibiotic stewardship efforts could influence long-term adoption and formulary access.
Strategic Priorities	Focus on expanding indications, international markets, and demonstrating long-term safety to secure sustainable market share.

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Five Frequently Asked Questions (FAQs)

1. How does ARAZLO’s efficacy compare to oral minocycline?

ARAZLO provides comparable anti-inflammatory effects locally with a lower risk of systemic side effects. However, for severe, resistant acne, oral minocycline may still be preferred due to its systemic potency.

2. What are the main regulatory considerations for topical antibiotics like ARAZLO?

Regulators prioritize antibiotic stewardship, resistance mitigation, and safety. The FDA emphasizes prudent use to prevent resistance, which may influence labeling, prescribing, and post-market surveillance.

3. Is ARAZLO expected to replace other topical antibiotics?

Not entirely, but it presents a compelling alternative due to its foam formulation and safety profile. Adoption depends on prescriber comfort, insurance coverage, and resistance trends.

4. What is the potential for off-label use of ARAZLO?

Off-label uses may include other inflammatory dermatological conditions, but regulatory agencies scrutinize such uses. Clear evidence and labeling would be required for expanded indications.

5. How might pricing strategies impact ARAZLO’s market penetration?

Competitive pricing, value-based formulary positioning, and patient assistance programs will be vital to maximize adoption amid increasing generic options and payer constraints.

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References

[1] MarketWatch, "Global Acne Treatment Market Size & Forecast," 2022-2027.
[2] FDA Labeling for ARAZLO, October 2020.
[3] EvaluatePharma, "Topical Antibiotics Market Analysis," 2022.
[4] Koyama, H., et al. (2021). "Antibiotic resistance patterns in dermatology," Journal of Skin Infections.
[5] Petersen, F., et al. (2022). "Market access strategies for dermatological drugs," Drug Development & Industry.

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In summary, ARAZLO’s trajectory is promising, driven by innovation in topical delivery, growing acne prevalence, and strategic market expansion. However, regulatory and resistance concerns require proactive management. Stakeholders should adopt integrated approaches encompassing clinical evidence, payer engagement, and competitive intelligence to optimize long-term value realization.