IMIQUIMOD - Generic Drug Details

What are the generic sources for imiquimod and what is the scope of patent protection?

Imiquimod is the generic ingredient in three branded drugs marketed by Bausch, Apotex Inc, Cosette, Encube, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Strides Pharma, and Taro, and is included in eleven NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imiquimod has fifty-eight patent family members in thirty-one countries.

There are fourteen drug master file entries for imiquimod. Eight suppliers are listed for this compound.

Summary for IMIQUIMOD

International Patents:	58
US Patents:	11
Tradenames:	3
Applicants:	9
NDAs:	11
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	172
Patent Applications:	6,703
Drug Prices:	Drug price trends for IMIQUIMOD
Drug Sales Revenues:	Drug sales revenues for IMIQUIMOD
What excipients (inactive ingredients) are in IMIQUIMOD?	IMIQUIMOD excipients list
DailyMed Link:	IMIQUIMOD at DailyMed

See drug prices for IMIQUIMOD

See drug sales revenues for IMIQUIMOD

Recent Clinical Trials for IMIQUIMOD

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

Sponsor	Phase
Medical University of Vienna	N/A
Northwestern University	Early Phase 1
Assiut University	Early Phase 1

See all IMIQUIMOD clinical trials

Pharmacology for IMIQUIMOD

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

Anatomical Therapeutic Chemical (ATC) Classes for IMIQUIMOD

D06BB	Antivirals
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for IMIQUIMOD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYCLARA	Cream	imiquimod	2.5%	022483	1	2014-06-17
ZYCLARA	Cream	imiquimod	3.75%	022483	1	2012-08-08
ALDARA	Cream	imiquimod	5%	020723	1	2006-10-17

US Patents and Regulatory Information for IMIQUIMOD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	10,238,645
Encube	IMIQUIMOD	imiquimod	CREAM;TOPICAL	091044-001	Feb 28, 2011		DISCN	No	No
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	11,850,245
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	8,236,816

Expired US Patents for IMIQUIMOD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997	4,689,338*PED
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997	7,696,159*PED
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997	5,238,944*PED

EU/EMA Drug Approvals for IMIQUIMOD

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 IMIQUIMOD

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2378876	FORMULATIONS D'IMIQUIMODE À FAIBLE FORCE DE DOSAGE ET SCHÉMAS POSOLOGIQUES COURTS POUR TRAITER LA KÉRATOSE ACTINIQUE (LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING ACTINIC KERATOSIS)
South Africa	201301397	LOWER DOSAGE STRENGHT IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS
Eurasian Patent Organization	201100984	КОМПОЗИЦИИ С БОЛЕЕ НИЗКИМ СОДЕРЖАНИЕМ ИМИКВИМОДА И КОРОТКИЕ РЕЖИМЫ ДОЗИРОВАНИЯ ДЛЯ ЛЕЧЕНИЯ АКТИНИЧЕСКОГО КЕРАТОЗА
Canada	2649893	FORMULATIONS D'IMIQUIMOD A FAIBLE DOSE ET SCHEMA POSOLOGIQUEDE COURTE DUREE PERMETTANT DE TRAITER LA KERATOSE SENILE (LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING ACTINIC KERATOSIS)

Supplementary Protection Certificates for IMIQUIMOD

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

IMIQUIMOD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Imiquimod

Introduction to Imiquimod

Imiquimod is an immune response modifier used in the treatment of various skin conditions, including actinic keratosis, superficial basal cell carcinoma, and genital warts. It is available in different strengths, such as 2.5%, 3.75%, and 5% creams, and is marketed under brand names like Aldara and Zyclara[5].

Market Size and Growth

The imiquimod market is part of several larger therapeutic markets, including the actinic keratosis treatment market and the genital warts treatment market.

• Actinic Keratosis Treatment Market: This market is expected to see significant growth, with the overall actinic keratosis treatment market projected to increase from USD 6,128.2 million in 2024 to USD 12,282.4 million by 2034, at a CAGR of 7.2%[3].
• Genital Warts Treatment Market: In this segment, imiquimod holds a dominant position with a 38% market share. The genital warts treatment market is anticipated to grow from USD 1,792.4 million in 2023 to USD 2,891.9 million by 2033, at a CAGR of 4.9%[4].

Segmentation and Application

By Type

Imiquimod creams are categorized based on their concentration:

• 2.5% Imiquimod Cream
• 3.75% Imiquimod Cream
• 5% Imiquimod Cream Each concentration has specific applications and market dynamics[1].

By Application

Imiquimod is used for various skin conditions:

• Skin Cancer: Including superficial basal cell carcinoma.
• Actinic Keratosis: A precursor to skin cancer.
• Genital Warts: A sexually transmitted infection.
• Other Applications: Such as treatment of certain types of warts[1][4].

Geographical Distribution

The market for imiquimod is spread across several regions:

• North America: Dominates the genital warts treatment market with a 38% market share and is also a significant player in the actinic keratosis treatment market[3][4].
• Europe: Countries like Germany and the UK show substantial growth rates, with Germany having a CAGR of 7.7% in the actinic keratosis treatment market[3].
• Asia-Pacific: This region is expected to experience substantial growth due to increasing awareness and government initiatives[3][4].
• Middle East and Africa: Also show potential for growth, though at a slower pace compared to other regions[1].

Cost-Effectiveness and Economic Analysis

Cost Comparison

Imiquimod has been shown to be cost-effective compared to other treatments:

• A study comparing imiquimod with topical fluorouracil and methylaminolaevulinate photodynamic therapy (MAL-PDT) found that imiquimod and fluorouracil were more cost-effective, with lower total mean costs (€526 for imiquimod and €388 for fluorouracil compared to €680 for MAL-PDT)[2].

Factors Affecting Cost

The cost of imiquimod can vary based on several factors:

• Treatment Plan: The duration and frequency of application.
• Insurance Coverage: Different insurance plans may cover varying percentages of the cost.
• Pharmacy: Prices can differ significantly depending on the pharmacy used[5].

Key Players and Market Competition

Several key players are involved in the production and distribution of imiquimod:

• Perrigo: Known for its dermatology portfolio, including imiquimod creams.
• 3M: Focuses on developing and manufacturing medical devices and treatments.
• Bausch Health: Acquired a portfolio of dermatology assets from LEO Pharma, including imiquimod creams.
• Merck & Co. Inc.: While not a primary producer of imiquimod, Merck's focus on HPV vaccines indirectly impacts the market for genital warts treatments[1][4].

Market Drivers and Opportunities

Increasing Prevalence of Skin Conditions

The growing number of cases of actinic keratosis and genital warts drives the demand for imiquimod. Increased awareness and diagnostic efforts contribute to this trend[3][4].

Advancements in Healthcare Infrastructure

Robust medical infrastructure, especially in regions like North America and Europe, supports the growth of the imiquimod market. Advances in telemedicine and e-health services also expand the reach of imiquimod treatments[3][4].

Rising Healthcare Expenditure

As economies grow, so does healthcare expenditure, creating a favorable environment for the expansion of the imiquimod market. Increased spending on preventive healthcare and treatment of STIs further boosts market growth[4].

Challenges and Restraints

Cost Variability and Insurance Coverage

The cost of imiquimod can be a barrier for some patients, especially those without comprehensive insurance coverage. Variability in pricing across different pharmacies and regions can also affect market dynamics[5].

Competition from Other Treatments

Imiquimod faces competition from other treatment options, such as topical fluorouracil and photodynamic therapy. The choice of treatment can be influenced by cost-effectiveness analyses and clinical outcomes[2].

Regional Growth Prospects

North America

North America is expected to continue dominating the market due to strong healthcare infrastructure and high awareness of skin diseases. The region is anticipated to grow at a CAGR of 7.6% in the actinic keratosis treatment market[3].

Asia-Pacific

This region is poised for significant growth driven by government initiatives, increasing awareness, and a large population base. India, in particular, is expected to lead in sales growth[3].

Key Takeaways

• Market Growth: The imiquimod market is expected to grow significantly, driven by increasing prevalence of skin conditions and advancements in healthcare infrastructure.
• Cost-Effectiveness: Imiquimod is generally more cost-effective than other treatments like MAL-PDT.
• Regional Dynamics: North America and Asia-Pacific are key regions driving market growth.
• Key Players: Companies like Perrigo, 3M, and Bausch Health play significant roles in the market.

FAQs

What are the primary applications of imiquimod?

Imiquimod is primarily used for treating actinic keratosis, superficial basal cell carcinoma, and genital warts.

How does the cost of imiquimod vary?

The cost of imiquimod can vary based on the treatment plan, insurance coverage, and the pharmacy used.

Which regions are expected to drive the growth of the imiquimod market?

North America and Asia-Pacific are expected to be the key drivers of market growth due to their strong healthcare infrastructure and increasing awareness of skin diseases.

What is the market share of imiquimod in the genital warts treatment market?

Imiquimod holds a 38% market share in the genital warts treatment market.

How does imiquimod compare to other treatments in terms of cost-effectiveness?

Imiquimod is generally more cost-effective than treatments like MAL-PDT, with lower total mean costs and a higher probability of being cost-effective at certain threshold values[2].

Cited Sources

1. Global Imiquimod Cream Market Size, Scope And Forecast Report - Market Research Intellect
2. Cost-effectiveness of topical imiquimod and fluorouracil vs ... - PubMed
3. Actinic Keratosis Treatment Market Analysis & Opportunity 2034 - Future Market Insights
4. Genital Warts Treatment Market Size, Share | CAGR of 4.9% - Market.US
5. Imiquimod cost 2024: Coupons and more - Medical News Today