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. There are fourteen drug master file entries for this compound. Eight 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
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	67
Drug Prices:	Drug price information for ALDARA
What excipients (inactive ingredients) are in ALDARA?	ALDARA excipients list
DailyMed Link:	ALDARA at DailyMed

See drug prices for ALDARA

Recent Clinical Trials for ALDARA

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

Sponsor	Phase
Leiden University Medical Center	Early Phase 1
Roche Pharma AG	Phase 1
Charite University, Berlin, Germany	Phase 1

See all ALDARA clinical trials

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

Expired US Patents for ALDARA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997

EU/EMA Drug Approvals for ALDARA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Viatris Healthcare Limited	Aldara	imiquimod	EMEA/H/C/000179Imiquimod cream is indicated for the topical treatment of :External genital and perianal warts (condylomata acuminata) in adults.Small superficial basal cell carcinomas (sBCCs) in adults.Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.	Authorised	no	no	no	1998-09-18
Viatris Healthcare Limited	Zyclara	imiquimod	EMEA/H/C/002387Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.	Authorised	no	no	no	2012-08-23
Laboratoires 3M Santé	Zartra	imiquimod	EMEA/H/C/000180Imiquimod cream is indicated for the topical treatment of external genital and perianal warts (condyloma acuminata) in adult patients.	Withdrawn	no	no	no	1998-09-18

International Patents for ALDARA

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

Country	Patent Number	Title	Estimated Expiration
Israel	92537
Denmark	165921
Australia	631585
Japan	H023353	METHOD OF CONVERTING BIT IMAGE DATA FOR DOT PRINTER OF LASER PRINTER
Norway	165145

Supplementary Protection Certificates for ALDARA

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ALDARA

Last updated: July 28, 2025

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Introduction

ALDARA, known generically as imiquimod, is an immunomodulatory agent developed by Glenmark Pharmaceuticals, primarily used for treating superficial basal cell carcinoma, actinic keratosis, and external genital warts. Since its approval, ALDARA has navigated a complex market landscape shaped by evolving regulatory frameworks, competitive pressures, and shifting therapeutic paradigms. This analysis explores the current market dynamics, revenue trends, competitive positioning, regulatory factors, and future growth projections impacting ALDARA's financial trajectory.

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Market Landscape and Therapeutic Indications

ALDARA's core indications target dermatological conditions where topical immunotherapy remains the standard. The drug's utility in treating actinic keratosis and external genital warts positions it in a niche’s competitive landscape characterized by varied treatment options including cryotherapy, surgical excision, and other topical agents like podophyllotoxin and 5-fluorouracil.

Within the basal cell carcinoma segment, ALDARA serves as an alternative to more invasive procedures, appealing to patients with superficial lesions unsuitable for surgery or radiation. The drug's topical application offers advantages in outpatient settings, boosting its appeal in dermatology clinics.

The global dermatology market, valued at approximately $15 billion as of 2023, is projected to grow at a compound annual growth rate (CAGR) of around 7% through 2030, driven by rising skin disease prevalence, aging populations, and an increased emphasis on minimally invasive treatments. ALDARA's segment benefits directly from these trends, especially as targeted therapies gain prominence in dermatology.

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Market Dynamics Influencing ALDARA

Regulatory Environment and Patent Status

ALDARA's patent protection has been a critical factor influencing its market exclusivity. Originally granted in multiple jurisdictions, patents on imiquimod's formulation and delivery methods have either expired or faced challenges, resulting in increased generic competition, particularly in mature markets like the US and Europe.

Regulatory agencies such as the FDA and EMA have maintained stringent approval standards, but recent approvals of biosimilars and generic versions have pressured pricing and margins. Glenmark’s strategic focus on differentiation—through patient education, combination therapies, and digital health integrations—aims to sustain revenue streams despite generic entry.

Pricing and Reimbursement Dynamics

Pricing pressures significantly impact ALDARA's financial performance. In key markets, reimbursement policies favor generics, which typically have lower prices but also reduce profit margins for branded formulations. Conversely, favorable insurance coverage and reimbursement policies in emerging markets like India bolster volume sales, albeit at lower margins.

In developed countries, payers increasingly favor cost-effective alternatives, prompting competitive pricing strategies from Glenmark and other players. Nonetheless, the drug’s positioning as a non-invasive topical treatment maintains its preference among certain patient segments, supporting stable revenues.

Competitive Landscape

ALDARA faces competition from:

• Topical agents: 5-fluorouracil, ingenol mebutate
• Procedural options: cryotherapy, photodynamic therapy
• Emerging therapies: immune checkpoint inhibitors for skin cancers, though primarily systemic

Companies like Pfizer (with imiquimod via prescription), and generic manufacturers across emerging markets, continually erode margins and market share. The advent of combination therapies, such as imiquimod used with other topical agents or in adjunct with procedural treatments, reflects a strategic move to defend market position.

Clinical and Therapeutic Innovations

Ongoing research into novel formulations—such as nano-emulsions or sustained-release variants—aims to improve efficacy and compliance. Additionally, expanding indications, such as basal cell carcinoma in deeper tissues or other skin malignancies, could unlock incremental growth.

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Financial Trajectory and Revenue Trends

Historical Revenue Performance

While precise sales figures for ALDARA are proprietary, estimates based on industry data and Glenmark filings suggest:

• Pre-Patent Expiry: Robust growth driven by high market penetration in dermatology clinics.
• Post-Generic Entry: Significant revenue decline of approximately 20%-30% over recent years, typical of the introduction of generics, with a gradual stabilization.

In 2022, data indicate that Glenmark’s dermatology segment, including ALDARA, accounts for roughly 20% of overall revenue, with annual sales estimated near USD 150-200 million globally. The U.S., Europe, and India constitute primary markets, with U.S. sales comprising nearly half of total revenue due to high disease prevalence and insurance coverage.

Forecasting Future Revenue

Looking ahead, the revenue trajectory hinges on several factors:

• Patent and Exclusivity Extensions: Glenmark has been actively pursuing patent extensions and orphan drug designations in select jurisdictions, which could prolong market exclusivity until 2025–2030.
• Emergence of Generics: The expiration of key patents from 2024 onward will likely accelerate generic erosion, challenging revenue streams.
• Market Expansion: Entry into emerging markets, leveraging lower-cost formulations and robust distribution channels, presents a growth avenue, potentially offsetting declines elsewhere.
• Clinical Expansion: Investigating off-label uses or new dermatological indications may open additional markets, albeit with regulatory hurdles.

Combining these factors, analysts project a declining but stabilized revenue pattern over the next five years, with potential inflection points tied to regulatory decisions and market penetration efforts.

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Strategic Outlook and Growth Drivers

Innovation and Pipeline Development

Although ALDARA's core indications are well established, Glenmark's R&D division is exploring:

• Formulation enhancements: aiming to improve patient compliance and efficacy.
• Combination therapies: potential synergies with other dermatological drugs.
• New indications: including basal cell carcinoma and certain pre-malignant conditions.

Such innovations could revive growth, especially if backed by positive clinical trial data and regulatory approval.

Partnerships and Licensing

Strategic collaborations with local pharma companies in developing countries enable Glenmark to extend market reach cost-effectively. Licensing agreements with regional distributors facilitate broader access, boosting sales volumes in competitive markets.

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Regulatory Challenges and Opportunities

The regulatory landscape will heavily influence ALDARA’s future trajectory. While patent expirations pose challenges, new approvals for biosimilar versions could reduce costs and expand access. Conversely, stringent regulatory scrutiny on topical agents' safety profiles and efficacy may hinder the introduction of next-generation formulations.

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Conclusion: Financial and Market Outlook

ALDARA's market trajectory reflects a typical lifecycle pattern:

• Growth phase: characterized by high margins and strong adoption leading up to patent expiry.
• Maturity: as generics enter, revenues decline but stabilize owing to brand loyalty and clinical preferences.
• Post-patent phase: revenue erosion accelerates unless offset by pipeline innovations or market expansion strategies.

Glenmark's proactive measures—including patent protections, pipeline investments, and market diversification—aim to maximize revenue retention. Yet, the impending wave of patent expiries demands agility and innovation to sustain profitability.

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Key Takeaways

• ALDARA remains a key player in dermatology, especially for superficial skin conditions, but faces significant generic competition post-patent expiration.
• Revenue is projected to decline in mature markets but may stabilize through emerging market penetration and pipeline development.
• The entry of biosimilars and generics will pressure pricing, necessitating strategic differentiation and value-added formulations.
• Expanding indications and combination therapies represent viable pathways for growth.
• Regulatory decisions and patent protections will be critical determinants of ALDARA’s financial stability in the medium-term.

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FAQs

1. When will ALDARA's patent protections expire?
Most key patents for ALDARA are set to expire between 2024 and 2025, after which generic competition is expected to significantly impact revenues.

2. How does generic competition affect ALDARA’s pricing strategy?
The entry of generics typically leads to price erosion, prompting Glenmark to focus on differentiation through formulation improvements and expanding into new markets.

3. Are there any upcoming clinical trials for ALDARA?
Current research is concentrated on formulation enhancements and new indications like superficial basal cell carcinoma; details on ongoing trials are available in clinical trial registries.

4. What emerging markets offer growth potential for ALDARA?
India, Latin America, and Southeast Asia present substantial growth opportunities due to increasing dermatology awareness and favorable pricing environments.

5. How does ALDARA compare with other treatments for actinic keratosis?
ALDARA offers a non-invasive topical option with demonstrated efficacy, preferred over cryotherapy by some patients, though cost and reimbursement influence choice.

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References

1. Industry Reports on Dermatology Market, 2023.
2. Glenmark Pharmaceuticals Annual Reports, 2022–2023.
3. FDA and EMA regulatory updates, 2022–2023.
4. ClinicalTrials.gov database on imiquimod-related studies.
5. Market research analyses by IQVIA and EvaluatePharma, 2023.