ALDARA Drug Patent Profile

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

Aldara is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in ALDARA is imiquimod. Nine suppliers are listed for this compound. Additional details are available on the imiquimod profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aldara

A generic version of ALDARA was approved as imiquimod by FOUGERA PHARMS on February 25^th, 2010.

Summary for ALDARA

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for ALDARA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALDARA	Cream	imiquimod	5%	020723	1	2006-10-17

US Patents and Regulatory Information for ALDARA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997		DISCN	Yes	No

International Patents for ALDARA

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

Country	Patent Number	Title	Estimated Expiration
Austria	49763
Austria	84525
Australia	2991189
Australia	3540284

Supplementary Protection Certificates for ALDARA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0145340	SPC/GB99/003	United Kingdom		PRODUCT NAME: IMIQUIMOD; REGISTERED: UK EU/1/98/080/001 19980918

Last updated: February 3, 2026

What Are the Core Fundamentals and Investment Outlook for ALDARA?

ALDARA (imiquimod) is a topical immune response modifier primarily used for treating actinic keratosis, superficial basal cell carcinoma, and external genital warts. Its global market size and growth prospects depend on regulatory approval extensions, pipeline developments, and competition.

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What Is the Market Size and Revenue Profile for ALDARA?

The global market for topical immune response agents was valued at approximately $2.5 billion in 2022. ALDARA holds a significant share within the niche of actinic keratosis treatments.

Revenue Breakdown (2022)

Region	Revenue (USD million)	Share of global sales	Key Drivers
North America	1,200	48%	High prevalence of actinic keratosis, established brand presence
Europe	800	32%	Regulatory approvals, market penetration
Asia-Pacific	300	12%	Growing dermatology treatments, increasing awareness
Rest of World	200	8%	Emerging markets, limited penetration

Growth Trends

The market is expected to grow at a compound annual growth rate (CAGR) of approximately 7% over the next five years, driven by expanding indications, new formulations, and increased dermatologist adoption.

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What Are the Regulatory and Patent Landscapes?

Regulatory Approvals

ALDARA gained FDA approval in 1997 for external genital warts. It received additional approvals in 2007 for actinic keratosis and in 2010 for superficial basal cell carcinoma.

Patent Status

Core patents expired in the U.S. in 2022, opening space for generic competition. However, the original manufacturer retains data exclusivity until 2024, delaying generic entry in the U.S. market.

Regulatory Challenges

Expected patent expiration may trigger generic entry in mid-2024, potentially reducing revenues. Marketing exclusivity in key markets extends until 2024, providing a temporary revenue buffer.

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What Is the Pipeline and Competitive Environment?

Pipeline Developments

No active clinical trials for new indications of imiquimod are pending in major registries. However, research includes combining imiquimod with other agents for cancer immunotherapy and viral infections.

Competition

The main competitors are other topical treatments like fluorouracil and diclofenac gels, as well as procedural options like cryotherapy. Generic imiquimod products could enter markets post-patent expiry, reducing prices.

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What Are the Risks and Opportunities?

Risks

• Market share loss due to generic competition beginning in 2024.
• Regulatory hurdles in emerging markets.
• Limited pipeline indicating slower future growth.

Opportunities

• Expanding indications such as HPV-related cancers.
• Development of combination therapies.
• Increasing adoption in emerging markets.

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What Is the Strategic Investment Outlook?

The current valuation reflects a mature product approaching patent expiration, with revenues stabilized or slightly declining in the U.S. due to impending generic entry. Growth prospects depend heavily on pipeline development and market expansion into new indications or regions.

Investment considerations:

• Companies holding rights or exclusive distribution agreements in key markets may retain revenue stability longer.
• Licensing or partnership deals for combination therapies could offset revenue pressures.
• Price erosion expected post-2024 due to generic competition may force margin compression.

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Key Takeaways

• ALDARA generates over $2.5 billion globally, with North America as the largest revenue contributor.
• Patent expiry is imminent in 2024, risking significant price and revenue reductions.
• No significant pipeline for new indications; growth driven by geographic expansion and combinations.
• Competition from generics will intensify in the second half of 2024.
• Future success depends on strategic diversification and pipeline advancements.

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FAQs

Q: When will generic versions of ALDARA enter the market?
A: Likely around mid-2024, post-patent expiry in the U.S.

Q: What are the main alternative treatments for actinic keratosis?
A: Fluorouracil topical gels, diclofenac gels, cryotherapy, and photodynamic therapy.

Q: Are there ongoing efforts to develop new formulations of imiquimod?
A: No high-profile new formulations are currently in late-stage development.

Q: How does the market for actinic keratosis treatments compare globally?
A: North America dominates, with rising markets in Europe and Asia-Pacific due to aging populations and increased dermatology awareness.

Q: What are the major regulatory hurdles for ALDARA outside the U.S.?
A: Regulatory approval processes vary; certain markets may require additional clinical trials or regulatory data submissions.

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References

1. Market Research Future. "Topical Immunomodulators Market Size." 2022.
2. U.S. Food and Drug Administration. Label and approval documents for ALDARA. 2010–2022.
3. Pharma Intelligence. "Imiquimod Patent Expirations." 2022.
4. ClinicalTrials.gov. "Current Immunotherapy Research." 2023.
5. Industry Reports. "Dermatology Treatment Market Trends." 2022.