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. Twenty-two 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

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

International Patents for CARAC

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

Country	Patent Number	Title	Estimated Expiration
Australia	7132287
Japan	S63256126	MANUFACTURE OF TIME RELEASING DISCHARGE MEDIUM
Australia	591264
European Patent Office	0285694	POROUS POLYMERIC BEADS FOR THE DELIVERY OF AN ACTIVE INGREDIENT
Germany	3774266
Japan	2680304

Investment Scenario and Fundamentals Analysis for CARAC (5-Fluorouracil Topical)

Last updated: February 3, 2026

Overview

CARAC (5-fluorouracil 0.5% topical cream) is indicated for the treatment of actinic keratosis, superficial basal cell carcinoma, and certain types of skin cancers. It is marketed by Taiho Oncology, a division of Taiho Pharmaceutical. The drug operates as a chemotherapy agent, targeting abnormal cells on the skin surface. Its sales are driven by the prevalence of skin cancer and actinic keratosis, along with increasing awareness and diagnosis.

Market Position and Competitive Landscape

• Product Status: CARAC is a branded, FDA-approved topical chemotherapeutic for skin lesions. It faces competition mainly from generic 5-fluorouracil formulations and alternative therapies such as imiquimod and diclofenac.
• Patent Status: No U.S. patent protection remains; the product is off-patent, leading to pricing and market share pressure from generics.
• Market Penetration: Well-established in dermatology clinics, with steady prescriber familiarity. Limited direct-to-consumer marketing.

Market Size and Growth Drivers

• Global Actinic Keratosis Market: Estimated to be USD 950 million in 2022, expected to grow at CAGR of approximately 4.2% through 2030 [1].
• U.S. Market: Represents roughly 60% of the global market, with USD 570 million sales in 2022.
• Prevalence Factors: Aging population, increased UV exposure, and heightened skin cancer awareness expand the patient base.

Financial Fundamentals

Metric	2022	Notes
Sales	Approx. USD 50 million	Majority from U.S., limited international revenues
Market Share	Estimated 15-20%	Going to generics, market share decreasing
Pricing	USD 250–300 per tube	Slight decline due to generics entry
Manufacturing Cost	Estimated USD 10–15 per tube	Typical for topical formulations with active ingredient

Revenue Trends and Outlook

• Historical Sales: Moderate growth in recent years, with revenues stabilized due to generic competition.
• Future Potential: Depends on extension of indications, geographic expansion, and combination with other therapies.
• Impact of Generics: Price erosion expected, reducing profit margins; sales growth limited unless new formulations or patents are pursued.

Regulatory and Policy Environment

• Patent Expiration: No active patents, making exclusive rights unattainable.
• FDA Approvals: Confirmed for actinic keratosis, with no recent label expansions.
• Pricing and Reimbursement: U.S. Medicare and private insurers reimburse at standard rates; cost-effectiveness is a threshold for formulary inclusion.

Strategic Opportunities and Risks

• Opportunities:

  • Development of combination therapies with novel agents.
  • Expansion into emerging markets with growing skin cancer incidence.
  • Formulation improvements to enhance patient compliance.

• Risks:

  • Price erosion due to generics.
  • Competitive therapies gaining market share.
  • Regulatory hurdles for new indications or formulations.
  • Limited patent protection reducing pricing power.

Investment Considerations

• Valuation: A mature product with declining margins due to generic competition.
• Growth prospects: Moderate unless new indications or formulations emerge.
• Partnerships: Licensing or co-development deals could mitigate risk.
• Market risks: Shifts toward novel treatments, low-cost generics, and market saturation.

Key Takeaways

• CARAC is a well-established topical chemotherapeutic for skin cancers, with stable but mature sales.
• No patent protection limits pricing power, exposing revenues to generic erosion.
• The market is expanding globally, though growth is tempered by competition and regulatory factors.
• Investment returns hinge on pipeline development, geographic expansion, and pricing strategies.

---

FAQs

1. What factors influence CARAC's market share?
Market share is affected by the availability of generics, prescriber habits, competition from other topical agents, and patient preferences.

2. How do patent expirations impact CARAC’s revenue?
The absence of active patents allows generic competition, reducing prices and making it challenging to maintain high margins or market share.

3. What are the growth prospects for CARAC?
Growth potential hinges on international expansion, new formulation development, and combination therapies, all constrained by the lack of patent exclusivity.

4. How significant is the market for actinic keratosis?
It is a USD 950 million global market, with growth driven by aging populations and increased skin cancer awareness.

5. What strategic moves could benefit CARAC’s future valuation?
Developing new indications, differentiating formulations, pursuing licensing agreements, and expanding into emerging markets offer potential pathways.

---

References

[1] MarketData Reports, "Global Actinic Keratosis Market," 2022.