ATRALIN Drug Patent Profile

When do Atralin patents expire, and when can generic versions of Atralin launch?

Atralin is a drug marketed by Dow Pharm and is included in one NDA.

The generic ingredient in ATRALIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atralin

A generic version of ATRALIN was approved as tretinoin by PADAGIS US on December 24^th, 1998.

Summary for ATRALIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	6
Drug Prices:	Drug price information for ATRALIN
What excipients (inactive ingredients) are in ATRALIN?	ATRALIN excipients list
DailyMed Link:	ATRALIN at DailyMed

See drug prices for ATRALIN

See drug sales revenues for ATRALIN

Recent Clinical Trials for ATRALIN

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

Sponsor	Phase
Zeichner, Joshua, M.D.	Phase 4
Johns Hopkins University	Phase 2
Lisa E. Maier	Phase 3

See all ATRALIN clinical trials

Pharmacology for ATRALIN

Drug Class

Retinoid

US Patents and Regulatory Information for ATRALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dow Pharm	ATRALIN	tretinoin	GEL;TOPICAL	022070-001	Jul 26, 2007	AB	RX	Yes	Yes

Expired US Patents for ATRALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dow Pharm	ATRALIN	tretinoin	GEL;TOPICAL	022070-001	Jul 26, 2007	5,670,547

International Patents for ATRALIN

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	233153	MOISTURISING VEHICLE FOR THE TOPICAL APPLICATION OF VITAMIN A IN ACID FORM
China	1047802
Norway	901657
Portugal	93638

Supplementary Protection Certificates for ATRALIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	PA2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + 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	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

ATRALIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atralin (Tretinoin)

Introduction to Atralin

Atralin, a brand name for the drug tretinoin, is a derivative of vitamin A used primarily in the treatment of various dermatological conditions, including acne and skin aging. Understanding the market dynamics and financial trajectory of Atralin is crucial for stakeholders in the pharmaceutical and skincare industries.

Market Size and Forecast

The global tretinoin market, which includes Atralin, is projected to experience significant growth. As of 2024, the market size was valued at USD 2.5 billion and is expected to reach USD 7.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10.1% during the forecast period[4].

Key Market Drivers

Several factors drive the demand for tretinoin and, by extension, Atralin:

Expansion of the Beauty and Cosmetics Sector

The growing demand for skincare products, particularly those with anti-aging and skin-renewing properties, significantly influences the market. Tretinoin's efficacy in these areas makes it a popular ingredient in skincare formulations[4].

Prescription Medications

Tretinoin is a prescription-only drug for specific dermatological conditions, such as acne vulgaris and certain types of leukemia. The demand for effective and scientifically validated therapies drives the prescription market for tretinoin[4].

Clinical Development and Research

Ongoing research and development in dermatology and skincare lead to innovations in tretinoin formulations. New products and formulations help expand the market[4].

Patient Preference for Topical Treatments

Patients often prefer topical treatments for dermatological issues, which fuels the demand for tretinoin products available in various topical formulations[4].

Dermatologist Recommendations

Dermatologists frequently recommend tretinoin for various skin issues, increasing consumer awareness and demand for products containing this ingredient[4].

Geographic Market Dynamics

North America

North America, particularly the United States, is one of the largest markets for tretinoin. The high prevalence of acne vulgaris and the early approval of tretinoin products in the U.S. contribute to this market's significance[1][4].

Europe

Europe is another major market for tretinoin, with a strong demand driven by the need for effective skincare and dermatological treatments[1][4].

Asia-Pacific

The Asia-Pacific region, especially Japan, is expected to provide significant market opportunities. Companies like Chugai, controlled by F. Hoffmann-La Roche AG, play a crucial role in this market with products like Vesanoid (tretinoin) for leukemia treatment[1].

Middle East and Africa, Latin America

These regions also show growing demand for tretinoin, driven by increasing awareness of skincare and dermatological treatments[4].

Distribution Channels

Pharmacies and Drugstores

Over-the-counter tretinoin products are commonly available in pharmacies and drugstores. Stronger formulations, however, are dispensed through prescriptions by healthcare professionals[4].

Prescription Dispensing

Prescription dispensing is a critical channel for tretinoin, especially for specific dermatological conditions that require stronger formulations[4].

Online Retail

The growing trend of online retail has made tretinoin-containing products available through e-commerce platforms, further expanding market reach[4].

Financial Trajectory

Research and Development Expenses

Companies involved in the development of tretinoin products, such as Sol-Gel Technologies Ltd., invest significantly in research and development. For instance, Sol-Gel's research and development expenses increased from $7.184 million in 2015 to $17.023 million in 2016, reflecting the ongoing efforts to innovate and expand product lines[2].

Revenue and Profit Trends

The generic drug industry, including tretinoin, is characterized by declining prices as the number of competitors increases. However, the initial generic monopolist can command prices 35% to 50% above long-run marginal costs. As more competitors enter the market, prices approach long-run marginal costs[3].

Company Performance

Companies like Valeant Pharmaceuticals International, Inc. (now Bausch Health), which have been involved in the development and marketing of tretinoin products, have experienced significant financial changes. Valeant's efforts to refocus R&D investments and divest non-core assets have been part of their turnaround strategy. For example, they divested their consumer skincare business, including brands like CeraVe and AcneFree, to L’Oreal for $1.3 billion, which helped in reducing their debt[5].

Key Takeaways

• The global tretinoin market is expected to grow significantly, driven by the beauty and cosmetics sector, prescription medications, and ongoing research.
• North America and Europe are the largest markets, with Asia-Pacific, particularly Japan, offering significant growth opportunities.
• Distribution channels include pharmacies, prescription dispensing, and online retail.
• Companies invest heavily in research and development to innovate and expand product lines.
• Financial trajectories are influenced by competition, pricing strategies, and company restructuring efforts.

FAQs

Q: What is the primary use of Atralin (tretinoin)? A: Atralin (tretinoin) is primarily used for the treatment of acne vulgaris and other dermatological conditions, as well as for certain types of leukemia.

Q: Which regions are the largest markets for tretinoin? A: North America and Europe are currently the largest markets for tretinoin, with the Asia-Pacific region, especially Japan, expected to provide significant growth opportunities.

Q: How does the number of competitors affect the price of generic tretinoin? A: The price of generic tretinoin declines as the number of competitors increases, approaching long-run marginal costs when there are eight or more competitors[3].

Q: What are the key drivers of the tretinoin market? A: The key drivers include the expansion of the beauty and cosmetics sector, demand for prescription medications, ongoing clinical development and research, patient preference for topical treatments, and recommendations from dermatologists[4].

Q: How have companies like Valeant Pharmaceuticals International, Inc. managed their financial trajectory in the tretinoin market? A: Companies like Valeant have refocused their R&D investments, divested non-core assets, and reduced debt through strategic sales and refinancing efforts[5].

Sources

1. Fortune Business Insights: Tretinoin Market Size, Industry Share | Forecast 2032
2. Sol-Gel Technologies Ltd: SEC Filing
3. Federal Trade Commission: Generic Drug Industry Dynamics
4. Verified Market Research: Tretinoin Market Size, Share, Scope, Trends And Forecast
5. Valeant Pharmaceuticals International, Inc.: 2016 Annual Report