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. There is one patent protecting this drug and one Paragraph IV challenge.

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:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	67
Patent Applications:	4,433
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
Johannes Gutenberg University Mainz	Phase 1
German Cancer Research Center	Phase 1

See all ALDARA clinical trials

Pharmacology for ALDARA

Mechanism of Action	Interferon Inducers
Physiological Effect	Increased Cytokine Activity Increased Cytokine Production

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					Y

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/000179 Imiquimod 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/002387 Zyclara 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/000180 Imiquimod 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
Norway	890822
Ireland	893888
Denmark	135791
Australia	3540284
Spain	537677
Denmark	164451

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

ALDARA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aldara (Imiquimod)

Introduction to Aldara (Imiquimod)

Aldara, also known as imiquimod, is an immune response modifier (IRM) that has been widely used in the treatment of various skin conditions, including external genital and perianal warts, actinic keratosis, and superficial basal cell carcinoma (sBCC).

Historical Context and FDA Approvals

In the early 2000s, 3M submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to market Aldara cream for the treatment of superficial basal cell carcinoma, a common form of non-melanoma skin cancer. This submission was based on positive results from two double-blind, randomized, placebo-controlled clinical trials involving 724 patients with sBCCs[1].

Clinical Efficacy

The clinical trials demonstrated significant efficacy of Aldara cream in treating sBCC. Patients treated with Aldara cream five times per week showed a histological clearance rate of 82% compared to only 3% in the placebo group. Similarly, patients treated seven times per week had a clearance rate of 79% versus 3% for the placebo group[1].

Market Expansion and Indications

Aldara has been approved for multiple indications, including:

• Actinic Keratosis: A common precursor to skin cancer, for which Aldara has shown promising results, particularly when used in conjunction with other treatments like photodynamic therapy (PDT)[3][4].
• Superficial Basal Cell Carcinoma: As mentioned, Aldara has been approved for the treatment of sBCC, offering a new option for dermatologists and other physicians[1].

Market Size and Growth

The market for treatments of skin neoplasms, including actinic keratosis and basal cell carcinoma, is experiencing significant growth.

Actinic Keratosis Treatment Market

The actinic keratosis treatment market is projected to grow from $6,128.2 million in 2024 to $12,282.4 million by 2034, with a Compound Annual Growth Rate (CAGR) of 7.2% during this period. This growth is driven by increasing incidence rates and advancements in diagnostic and therapeutic technologies[3].

Skin Neoplasms Market

The broader skin neoplasms market, which includes treatments for various types of skin cancers, is expected to reach $3.8 billion by 2034, growing at a CAGR of 4.91% from 2024 to 2034. This market is driven by advancements in targeted therapies and immunotherapies, with Aldara being a notable player[4].

Financial Performance and Revenue Projections

While specific financial data for Aldara alone is not readily available, the performance of companies involved in its development and marketing provides insights into its financial trajectory.

3M Pharmaceuticals

3M's submission and subsequent approvals for Aldara have contributed to the company's pharmaceutical division's growth. Although detailed financial figures specific to Aldara are not provided, the success of Aldara in clinical trials and its market approval indicate a positive financial impact on 3M's pharmaceutical division[1].

Competitive Landscape

Aldara operates within a competitive landscape that includes other treatments for skin neoplasms.

Key Competitors

• Libtayo (Cemiplimab) by Regeneron Pharmaceuticals: Approved for treating advanced cutaneous squamous cell carcinoma (CSCC) and advanced basal cell carcinoma (BCC) that cannot be cured by surgery or radiation[4].
• Other IRMs and Targeted Therapies: The market is seeing an increase in precision medicine and targeted therapies, which are gaining traction due to their improved outcomes for patients with skin cancers[4].

Regional Market Analysis

The demand for Aldara and other skin neoplasms treatments varies by region.

Key Regions

• North America: The United States is a significant market, with a CAGR of 7.6% anticipated for the actinic keratosis treatment market from 2024 to 2034[3].
• Europe: Countries like Germany are also experiencing growth, with a CAGR of 7.7% expected during the same period[3].
• Asia Pacific: India is leading in sales growth, indicating a promising future for the sector in this region[3].

Future Outlook

Given the increasing prevalence of skin cancers and the growing awareness of the potential risks associated with actinic keratosis, the market for Aldara and similar treatments is poised for continued growth.

Emerging Trends

• Advancements in Diagnostic and Therapeutic Technologies: Innovations such as photodynamic therapy (PDT) and novel targeted drugs are expected to drive market growth[3][4].
• Increased Awareness and Clinical Diagnoses: Rising awareness of skin diseases and the risk of disease progression to cancer will stimulate sector growth[3].

Key Takeaways

• Clinical Efficacy: Aldara has demonstrated high efficacy in treating sBCC and actinic keratosis.
• Market Growth: The actinic keratosis and skin neoplasms markets are expected to grow significantly over the next decade.
• Competitive Landscape: Aldara competes with other advanced treatments like Libtayo.
• Regional Demand: North America, Europe, and Asia Pacific are key regions driving market growth.

FAQs

What is Aldara (Imiquimod) used for?

Aldara (Imiquimod) is used for the treatment of external genital and perianal warts, actinic keratosis, and superficial basal cell carcinoma (sBCC).

What are the clinical efficacy rates of Aldara for sBCC?

Patients treated with Aldara cream five times per week showed a histological clearance rate of 82%, while those treated seven times per week had a clearance rate of 79%[1].

How is the actinic keratosis treatment market expected to grow?

The actinic keratosis treatment market is projected to grow from $6,128.2 million in 2024 to $12,282.4 million by 2034, with a CAGR of 7.2%[3].

What are the key regions driving the growth of the skin neoplasms market?

North America, Europe, and Asia Pacific are the key regions driving the growth of the skin neoplasms market, with the United States, Germany, and India being significant contributors[3].

What are some of the emerging trends in the skin neoplasms market?

Emerging trends include advancements in diagnostic and therapeutic technologies, such as photodynamic therapy (PDT), and increased awareness and clinical diagnoses of skin diseases[3][4].

Sources

1. 3M News: "3M Submits Supplemental New Drug Application to FDA for Aldara (imiquimod) Cream, 5%, for the Treatment of Superficial Basal Cell Carcinoma"[1].
2. ADMA Biologics: "ADMA Biologics Announces First Quarter 2024 Financial Results and Provides Business Update"[2].
3. Future Market Insights: "Actinic Keratosis Treatment Market Analysis & Opportunity 2034"[3].
4. BioSpace: "Skin Neoplasms Market Estimated to Reach USD 3.8 Billion by 2034"[4].