TOLAK Drug Patent Profile

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

Tolak is a drug marketed by Hill Dermaceuticals and is included in one NDA.

The generic ingredient in TOLAK is fluorouracil. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tolak

A generic version of TOLAK was approved as fluorouracil by FRESENIUS KABI USA on September 30^th, 1998.

Summary for TOLAK

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	216
Patent Applications:	3,123
Drug Prices:	Drug price information for TOLAK
What excipients (inactive ingredients) are in TOLAK?	TOLAK excipients list
DailyMed Link:	TOLAK at DailyMed

See drug prices for TOLAK

Pharmacology for TOLAK

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

US Patents and Regulatory Information for TOLAK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hill Dermaceuticals	TOLAK	fluorouracil	CREAM;TOPICAL	022259-001	Sep 18, 2015		RX	Yes	Yes

Expired US Patents for TOLAK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hill Dermaceuticals	TOLAK	fluorouracil	CREAM;TOPICAL	022259-001	Sep 18, 2015	7,169,401

International Patents for TOLAK

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

Country	Patent Number	Title	Estimated Expiration
Canada	2541373	COMPOSITION TOPIQUE DE SOINS DE LA PEAU CONTENANT DE L'HUILEDE CACAHUETES RAFFINEE (TOPICAL SKIN CARE COMPOSITION CONTAINING REFINED PEANUT OIL)
World Intellectual Property Organization (WIPO)	2005009406
European Patent Office	1696868	COMPOSITION TOPIQUE DE SOINS DE LA PEAU CONTENANT DE L'HUILE DE CACAHUETES RAFFINEE (TOPICAL SKIN CARE COMPOSITION CONTAINING REFINED PEANUT OIL)

TOLAK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TOLAK

Introduction to TOLAK

TOLAK, a topical cream containing 4% fluorouracil, is a medication used to treat actinic keratosis (AK), a skin condition often referred to as solar keratoses or sunspots. Here, we will delve into the market dynamics and financial trajectory of TOLAK, highlighting key factors influencing its market presence.

Market Size and Growth

The global actinic keratosis treatment market, within which TOLAK operates, was valued at USD 6.4 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 4.3% from 2023 to 2030, reaching USD 8.9 billion by 2030[1].

Segmentation and Market Share

TOLAK falls under the nucleoside metabolic inhibitors segment, which held the largest revenue share of 32.4% in 2022. This segment's growth is driven by the strong commercial performance of drugs like Efudex, Carac, and Fluoroplex, all of which are in the same drug class as TOLAK[1].

End-Use Segments

The homecare segment, where TOLAK is primarily used, is expected to grow at the fastest CAGR of 5.2% during the forecast period. This growth is attributed to the rising adoption of topical products, patient convenience, and the increasing availability of over-the-counter (OTC) products[1].

Regional Outlook

The market for actinic keratosis treatments, including TOLAK, is geographically diverse. North America, particularly the U.S., is a significant market due to high prevalence rates and advanced healthcare infrastructure. Europe, with countries like the UK, Germany, and France, also represents a substantial market share[1].

Strategic Initiatives and Partnerships

Hill Dermaceuticals, Inc., the original developer of TOLAK, has entered into strategic partnerships to enhance the drug's market reach. For instance, Pierre Fabre Dermo-Cosmétique acquired the commercialization rights for TOLAK in the USA and other territories, facilitating broader distribution and marketing efforts[4].

Pricing and Affordability

The cost for TOLAK 4% topical cream is around $52 for a supply of 40 grams, depending on the pharmacy. This pricing is for cash-paying customers and does not include insurance plans. Patient assistance programs, such as the HealthWell Foundation Copay Program, are available to help eligible individuals cover the costs[2].

Drug Shortages and Market Sustainability

Drug shortages, particularly affecting off-patent drugs with low prices, can impact the market dynamics of TOLAK. These shortages are often due to price erosion, leading to oligopolies and reduced market resilience. However, TOLAK's status as a branded product with ongoing commercial support from partners like Pierre Fabre mitigates some of these risks[3].

Competitive Landscape

The actinic keratosis treatment market is competitive, with key players including Almirall, S.A., Bausch Health Companies Inc., Biofrontera, and LEO Pharma A/S. TOLAK competes with other topical treatments like Zyclara (imiquimod cream) and newer approvals such as Klisyri (tirbanibulin)[1].

Therapeutic Outlook

TOLAK is used in the topical treatment of actinic keratosis, a condition that is increasingly prevalent due to aging populations and higher exposure to UV radiation. The therapeutic outlook for TOLAK is positive, given the growing awareness and diagnosis rates of AK[1].

Financial Impact and Patient Assistance

The financial impact of TOLAK on patients can be significant, but various patient assistance programs and discount cards, such as the Drugs.com Discount Card, can help reduce costs. These programs are crucial in ensuring that patients can afford the treatment without incurring substantial out-of-pocket expenses[2].

Key Takeaways

• Market Growth: The global actinic keratosis treatment market, including TOLAK, is expected to grow at a CAGR of 4.3% from 2023 to 2030.
• Segment Leadership: TOLAK is part of the nucleoside metabolic inhibitors segment, which holds the largest revenue share.
• Strategic Partnerships: Partnerships with companies like Pierre Fabre have enhanced TOLAK's market reach.
• Pricing and Affordability: TOLAK's pricing is around $52 for a 40-gram supply, with patient assistance programs available.
• Competitive Landscape: TOLAK competes in a market with several key players and newer treatment options.

FAQs

Q: What is TOLAK used for? A: TOLAK is used to treat actinic keratosis, a skin condition caused by sun exposure.

Q: How much does TOLAK cost? A: The cost for TOLAK 4% topical cream is around $52 for a supply of 40 grams.

Q: Are there any patient assistance programs for TOLAK? A: Yes, programs like the HealthWell Foundation Copay Program can help eligible individuals cover the costs.

Q: Who are the key players in the actinic keratosis treatment market? A: Key players include Almirall, S.A., Bausch Health Companies Inc., Biofrontera, and LEO Pharma A/S.

Q: What is the expected growth rate of the global actinic keratosis treatment market? A: The market is expected to grow at a CAGR of 4.3% from 2023 to 2030.

Cited Sources

1. Grand View Research - Actinic Keratosis Treatment Market Size, Share Report, 2030
2. Drugs.com - Tolak Prices, Coupons, Copay Cards & Patient Assistance
3. Office of Health Economics - The Dynamics of Drug Shortages
4. Hill Dermaceuticals - Pierre Fabre and Hill Dermaceuticals, Inc. announce a strategic partnership
5. NPS MedicineWise - Tolak 4% Once Daily Cream