CARAC Drug Patent Profile

When do Carac patents expire, and what generic alternatives are available?

Carac is a drug marketed by Extrovis and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Carac

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

Summary for CARAC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	216
Patent Applications:	3,143
Drug Prices:	Drug price information for CARAC
What excipients (inactive ingredients) are in CARAC?	CARAC excipients list
DailyMed Link:	CARAC at DailyMed

See drug prices for CARAC

See drug sales revenues for CARAC

Paragraph IV (Patent) Challenges for CARAC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CARAC	Cream	fluorouracil	0.5%	020985	1	2011-07-29

US Patents and Regulatory Information for CARAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000		RX	Yes	Yes

Expired US Patents for CARAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000

International Patents for CARAC

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

Country	Patent Number	Title	Estimated Expiration
Australia	7132287
Austria	68965
European Patent Office	0285694	POROUS POLYMERIC BEADS FOR THE DELIVERY OF AN ACTIVE INGREDIENT
Germany	3774266
Japan	2680304
Japan	S63256126	MANUFACTURE OF TIME RELEASING DISCHARGE MEDIUM

Market Dynamics and Financial Trajectory for CARAC (Fluorouracil) in the Actinic Keratosis Treatment Market

Introduction to Actinic Keratosis and CARAC

Actinic keratosis (AK) is a common skin condition caused by prolonged exposure to the sun, leading to the formation of small, rough patches on the skin. CARAC, a brand name for Fluorouracil, is a topical medication widely used in the treatment of actinic keratosis.

Global Actinic Keratosis Treatment Market Overview

The global actinic keratosis treatment market 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].

Market Segmentation and CARAC's Position

Drug Class Outlook

The market is segmented into various drug classes, including nucleoside metabolic inhibitors, NSAIDs, immune response modifiers, photoenhancers, and others. Nucleoside metabolic inhibitors, which include CARAC (Fluorouracil), held the largest revenue share of 32.4% in 2022. This segment's growth is driven by the strong commercial performance of products like Efudex, Carac, and Fluoroplex[1].

CARAC's Role in the Market

CARAC, as a nucleoside metabolic inhibitor, plays a significant role in the treatment of actinic keratosis. It works by inhibiting thymidylate synthase, thereby interfering with DNA synthesis and leading to the death of rapidly dividing cells, such as those found in AK lesions.

Clinical Efficacy and Patient Preference

CARAC is preferred due to its efficacy in treating AK lesions. The topical application of CARAC allows for targeted treatment with minimal systemic side effects, making it a convenient option for patients.

Financial Performance and Revenue Streams

Revenue Contribution

The revenue generated by CARAC and similar nucleoside metabolic inhibitors is substantial. In 2022, this segment accounted for 32.4% of the total market revenue, driven by the commercial success of these products[1].

Market Growth Drivers

The growth of the market, including CARAC, is driven by several factors:

• Increasing Prevalence of AK: The rising prevalence of actinic keratosis due to increased sun exposure and an aging population.
• Generic Availability: The wide availability of generic versions of Fluorouracil, which increases accessibility and affordability.
• Strategic Initiatives: Industry players' strategic initiatives, such as product registrations and launches, contribute to market growth[1].

Regional Market Dynamics

Asia Pacific Growth

The Asia Pacific region is expected to grow at the fastest CAGR of 5.6% during the forecast period. This growth is attributed to increasing treatment adoption, rising disposable income, and high disease prevalence in countries like Australia and New Zealand[1].

End-Use Segments

Homecare Segment

The homecare segment, which includes topical products like CARAC, is expected to grow at the fastest CAGR of 5.2% during the forecast period. This growth is driven by patient convenience, the availability of over-the-counter (OTC) products, and the increasing launch of topical treatments[1].

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. These companies continually innovate and expand their product portfolios to maintain market share[1].

Regulatory and Strategic Initiatives

Companies like Hill Dermaceuticals, Inc. have made significant strides by registering their products in multiple countries. For instance, Tolak (Fluorouracil) 4% Cream, a product similar to CARAC, has been registered in 13 European countries, including the UK, France, and Italy[1].

Key Takeaways

• Market Growth: The global actinic keratosis treatment market is expected to grow at a CAGR of 4.3% from 2023 to 2030.
• CARAC's Role: CARAC, as a nucleoside metabolic inhibitor, holds a significant market share due to its efficacy and patient preference.
• Regional Growth: The Asia Pacific region is expected to grow at the fastest CAGR.
• End-Use Segments: The homecare segment, including topical products like CARAC, is expected to grow rapidly.
• Competitive Landscape: The market is competitive with key players continually innovating and expanding their product portfolios.

FAQs

1. What is the current market size of the global actinic keratosis treatment market? The global actinic keratosis treatment market was valued at USD 6.4 billion in 2022[1].

2. What is the expected CAGR of the global actinic keratosis treatment market from 2023 to 2030? The market is expected to grow at a CAGR of 4.3% from 2023 to 2030[1].

3. Which drug class holds the largest revenue share in the actinic keratosis treatment market? Nucleoside metabolic inhibitors, which include CARAC, held the largest revenue share of 32.4% in 2022[1].

4. What are the key drivers of the actinic keratosis treatment market growth? Key drivers include increasing prevalence of AK, generic availability, and strategic initiatives by industry players[1].

5. Which region is expected to grow at the fastest CAGR in the actinic keratosis treatment market? The Asia Pacific region is expected to grow at the fastest CAGR of 5.6% during the forecast period[1].

Sources:

1. Grand View Research: Actinic Keratosis Treatment Market Size, Share Report, 2030.
2. Cara Therapeutics: Cara Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results.
3. BioSpace: Cara Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results.
4. BioSpace: U.S. Actinic Keratosis Treatment Market Size Industry Analysis 2033.