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 two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in nineteen countries.

The generic ingredient in ARAZLO is tazarotene. There are eight drug master file entries for this compound. Eleven 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 TARO on April 3^rd, 2017.

Summary for ARAZLO

International Patents:	28
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	1
Patent Applications:	5,533
Drug Prices:	Drug price information 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 two 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

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
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)
Cyprus	1109189
South Africa	200301037	Topical gel delivery system.
Lithuania	3310389
Denmark	1304992
Japan	6997624

Supplementary Protection Certificates for ARAZLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
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
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203

ARAZLO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ARAZLO

Introduction to ARAZLO

ARAZLO is a prescription skincare medication containing tazarotene, a retinoid, designed to treat acne, including blackheads, whiteheads, and pimples. It is the first tazarotene lotion approved by Health Canada for the topical treatment of acne vulgaris in patients 10 years of age and older[2].

Market Context: Acne Treatment Market

The global acne treatment market is projected to grow significantly, with a market size expected to increase from $11.62 billion in 2024 to $17.48 billion by 2032, at a CAGR of 5.2% during the forecast period. This growth is driven by the rising prevalence of acne, particularly among adults and teenagers, and the increasing demand for advanced treatments[1].

Segment Analysis

Age Groups

The acne treatment market is segmented by age, with the 18 to 44 years segment expected to dominate the market share during the forecast period due to the increasing incidence of adult acne. The 10 to 17 years segment is also anticipated to witness considerable growth, aligning with the target demographic for ARAZLO[1].

Route of Administration

The market is divided into topical and oral treatments. Given that ARAZLO is a topical lotion, it benefits from the easy availability and preference for over-the-counter (OTC) and prescription topical products globally[1].

Regional Market Dynamics

North America

North America, particularly the U.S., dominates the acne treatment market, with a market size of $5.45 billion in 2023. This dominance is attributed to the high prevalence of acne and the introduction of new drugs by major players like Bausch Health Companies Inc., which launched ARAZLO in Canada and other regions[1].

Canada

In Canada, ARAZLO has been listed by public drug plans in Quebec, Ontario, Alberta, and Saskatchewan, as well as the federal government's Non-Insured Health Benefits (NIHB) drug plan. This widespread availability is expected to boost its adoption and market share[2].

Asia Pacific and Other Regions

The Asia Pacific region is expected to register the highest CAGR due to rising awareness and the increasing number of companies entering the market. Latin America and the Middle East & Africa will also see growth, though at a more moderate pace[1].

Financial Trajectory for ARAZLO

Revenue and Growth

Bausch Health Companies Inc., the manufacturer of ARAZLO, has seen significant revenue growth in its dermatology segment. The company's annual report highlights a strong outlook for dermatology products, with planned product launches and line extensions contributing to growth. The successful listing of ARAZLO in Canadian public drug plans is a key factor in its financial trajectory[3].

Market Penetration

Interest in ARAZLO has grown by 32% over the past year, with a current search volume of 35,000 searches per month. This growing interest, particularly among teenagers and younger people on platforms like TikTok, indicates increasing market penetration and potential for further revenue growth[4].

Cost and Pricing

The cost of ARAZLO, as a brand-name medication, varies depending on factors such as insurance coverage, treatment duration, and availability of savings programs. Comparatively, generic alternatives like tretinoin may offer different cost structures, but ARAZLO's unique formulation as a topical lotion positions it competitively in the market[5].

Competitive Landscape

ARAZLO competes in a market dominated by major players such as Allergan, GALDERMA, and Bausch Health Companies Inc. The launch of new products and the expansion of existing product lines are key strategies in this competitive landscape. Bausch Health's significant investment in direct-to-consumer advertising and digital engagement is expected to enhance ARAZLO's market presence[1][3].

Key Drivers and Challenges

Key Drivers

• Rising Prevalence of Acne: The increasing incidence of acne, especially among adults and teenagers, drives demand for effective treatments like ARAZLO.
• Advanced Treatments: The launch of new and advanced drugs, including ARAZLO, attracts patients seeking better outcomes.
• Market Availability: Widespread listing in public drug plans and online pharmacies enhances accessibility and adoption.

Challenges

• Cost and Insurance: The cost of ARAZLO and variations in insurance coverage can affect patient access and adherence.
• Competition: The presence of generic alternatives and other brand-name treatments poses a competitive challenge.
• Regulatory Approvals: Continuous regulatory approvals and negotiations with drug plans are necessary for sustained market growth.

Conclusion

ARAZLO is poised for significant growth within the acne treatment market, driven by its unique formulation, increasing market penetration, and strategic listings in public drug plans. As the global acne treatment market expands, ARAZLO's financial trajectory is expected to be robust, supported by Bausch Health's strong commercial efforts and the rising demand for effective acne treatments.

Key Takeaways

• ARAZLO is a prescription topical lotion containing tazarotene, approved for treating acne vulgaris in patients 10 years and older.
• The global acne treatment market is projected to grow at a CAGR of 5.2% from 2024 to 2032.
• North America, particularly the U.S. and Canada, is a dominant market for ARAZLO.
• Increasing interest and market penetration, especially among younger demographics, drive ARAZLO's revenue growth.
• Competitive strategies include direct-to-consumer advertising and digital engagement.

FAQs

1. What is ARAZLO used for? ARAZLO is a prescription skincare medication used to treat acne, including blackheads, whiteheads, and pimples, in patients 10 years of age and older.

2. How is ARAZLO different from other acne treatments? ARAZLO is the first tazarotene lotion approved for the topical treatment of acne vulgaris, distinguishing it from other treatments like tretinoin, which comes in various forms.

3. Where is ARAZLO available? ARAZLO is available through public drug plans in Quebec, Ontario, Alberta, and Saskatchewan, as well as the federal government's Non-Insured Health Benefits (NIHB) drug plan in Canada.

4. How fast is interest in ARAZLO growing? Interest in ARAZLO has grown by 32% over the past year, with a current search volume of 35,000 searches per month.

5. What are the key drivers for ARAZLO's market growth? Key drivers include the rising prevalence of acne, the launch of advanced treatments, and the widespread availability of ARAZLO through public drug plans and online pharmacies.

Sources

1. Fortune Business Insights: Acne Treatment Market Size, Trends | Revenue Share [2032]
2. Investing News: First tazarotene lotion treatment for acne vulgaris, ARAZLO, now available to patients through Quebec, Ontario, Alberta, Saskatchewan, and federal NIHb public drug plans
3. Bausch Health Companies Inc.: 2022 ANNUAL REPORT
4. Glimpse: Arazlo - Trending 32% (November 2024)
5. Healthline: Arazlo Cost 2024: Coupons and More