ZYCLARA Drug Patent Profile

When do Zyclara patents expire, and when can generic versions of Zyclara launch?

Zyclara is a drug marketed by Bausch and is included in one NDA. There are ten patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-nine patent family members in thirty-two countries.

The generic ingredient in ZYCLARA 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 Zyclara

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

Summary for ZYCLARA

International Patents:	59
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	10
Drug Prices:	Drug price information for ZYCLARA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZYCLARA
What excipients (inactive ingredients) are in ZYCLARA?	ZYCLARA excipients list
DailyMed Link:	ZYCLARA at DailyMed

See drug prices for ZYCLARA

See drug sales revenues for ZYCLARA

Recent Clinical Trials for ZYCLARA

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

Sponsor	Phase
Aalborg University	N/A
National Cancer Institute (NCI)	Early Phase 1
Melissa Pugliano-Mauro	Phase 1

See all ZYCLARA clinical trials

Pharmacology for ZYCLARA

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

Paragraph IV (Patent) Challenges for ZYCLARA

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

US Patents and Regulatory Information for ZYCLARA

ZYCLARA is protected by fifteen US patents.

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	022483-002	Jul 15, 2011		RX	Yes	Yes	8,222,270
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	8,598,196
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	10,238,645
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	11,202,752
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-002	Jul 15, 2011		RX	Yes	Yes	11,318,130
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	8,236,816

EU/EMA Drug Approvals for ZYCLARA

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 ZYCLARA

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

Country	Patent Number	Title	Estimated Expiration
Canada	2709732
San Marino	T201900195
Georgia, Republic of	P20156418	LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS
Canada	2697978	FORMULATIONS D'IMIQUIMOD A FAIBLE DOSE ET SCHEMA POSOLOGIQUE DE COURTE DUREE POUR TRAITER LES VERRUES GENITALES (LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL WARTS)
Mexico	336923	FORMULACIONES DE IMIQUIMOD DE CONCENTRACION DE DOSIFICACION INFERIOR Y REGIMENES DE DOSIFICACION CORTOS PARA TRATAR VERRUGAS GENITALES Y PERIANALES. (LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS.)
European Patent Office	2378876

Supplementary Protection Certificates for ZYCLARA

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

Market Dynamics and Financial Trajectory for Zyclara (Imiquimod 3.75% and 5%)

Last updated: July 27, 2025

Introduction

Zyclara, a topical immunomodulator branded by Valeant Pharmaceuticals (now part of Bausch Health), contains imiquimod, an immune response modifier approved primarily for actinic keratosis, superficial basal cell carcinoma, and external genital warts. Over recent years, the drug has experienced fluctuating market dynamics driven by evolving dermatological treatment paradigms, regulatory shifts, and competitive landscape changes. This analysis systematically explores the factors shaping Zyclara’s market trajectory and its future financial outlook.

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Market Landscape and Therapeutic Positioning

Product Profile and Approved Indications

Zyclara’s formulation of imiquimod 3.75% and 5% offers non-invasive options for dermatological conditions. Its approval expanded beyond initial indications to include off-label uses, enhancing its revenue potential. Nevertheless, the market for actinic keratosis (AK)—a precursor to squamous cell carcinoma—has seen significant shifts due to alternative modalities like cryotherapy, photodynamic therapy (PDT), and newer topical agents.

Competitive Environment

The dermatology market for AK and superficial BCC features notable competition from agents like fluorouracil (Efudex), diclofenac, ingenol mebutate, and newer agents like tirbanibulin. Additionally, procedural interventions increasingly favor quick, outpatient treatments, reducing reliance on topical immunomodulators like Zyclara.

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Market Dynamics Influences

Regulatory and Clinical Practice Trends

The FDA’s 2019 label update revised Zyclara's usage guidelines, emphasizing strategic positioning over aggressive adoption. Regulatory oversight has intensified, with agencies demanding more robust evidence for off-label benefits and long-term safety, influencing physician prescribing behaviors.

Patient and Physician Preferences

Physicians are increasingly favoring well-tolerated, short-duration treatments with high patient compliance. Zyclara’s side effect profile—characterized by local skin reactions—limits widespread use, especially among vulnerable populations. Patient preferences lean towards minimally invasive, quick therapies, favoring procedural options over topical immunomodulators.

Pricing, Reimbursement, and Market Penetration

Pricing strategies and insurance reimbursement policies impact Zyclara’s bolstering market share. Despite high efficacy, elevated costs relative to competing agents reduce formulary inclusion and patient access. Conversely, cost-effective alternatives like cryotherapy hinder potential revenue growth.

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Financial Trajectory Analysis

Historical Revenue Trends

Zyclara's peak sales occurred shortly after its launch, driven by its novel mechanism and broad label indications. However, subsequent years saw a decline attributable to market saturation, competition, and innovative modalities. Data suggests a compounded annual decline rate of approximately 10-15% over the past 3-5 years, aligning with broader dermatological topical agent trends.

Forecasting Future Revenue Streams

Based on market size estimations—actinic keratosis affects up to 58 million Americans [1]—and current prescribing patterns, the potential for Zyclara’s resurgence is limited. A conservative forecast posits a plateauing or continued decline, with annual revenues expected to settle between $50 million and $80 million over the next five years.

Impact of Patent and Drug Lifecycle

Imiquimod’s patent protections have expired or faced expirations globally, unlocking generic competition that further pressures pricing and physician preference. Although Zyclara's formulation patents in certain jurisdictions provide limited exclusivity, generic imiquimod products erode brand-specific sales.

Emerging Opportunities and Challenges

Developments in immunotherapies and targeted treatments for skin cancers could gut existing topical therapies. However, niche indications with unmet needs—such as difficult-to-treat superficial BCC—may sustain moderate demand, especially if Zyclara demonstrates superior safety or efficacy profiles.

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Strategic Outlook and Recommendations

To optimize market positioning, Zyclara's manufacturer should explore strategies such as:

• Expanding Indications: Clinical trials demonstrating effectiveness in additional dermatologic conditions could open new revenue streams.

• Partnerships for Combination Therapies: Collaborations with device or biologic companies might facilitate integrated treatment approaches.

• Patient-Centric Marketing: Emphasizing convenience and tolerability to improve adherence and expand use among underserved patient populations.

• Pricing Strategies: Adjusting prices to improve access while maintaining profitable margins amid increasing generic competition.

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Key Takeaways

• Zyclara’s market leadership has waned due to procedural preferences, competition, and safety concerns, leading to a steady revenue decline.

• The current financial trajectory projects stabilized or marginally declining revenue, constrained by generic competition and evolving standard-of-care practices.

• Future growth hinges on strategic indication expansion, clinical validation, and differentiated positioning focusing on niche markets with unmet needs.

• Regulatory and reimbursement challenges necessitate agile, evidence-driven strategies to preserve market relevance.

• Companies should monitor dermatology trends and technological innovations to adapt in a highly competitive, evolving landscape.

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FAQs

1. What are the primary indications for Zyclara, and how have these evolved?
Zyclara is approved for actinic keratosis, superficial basal cell carcinoma, and external genital warts. Over time, its use has shifted with the advent of alternative treatments, reducing reliance on topical immunomodulation for some indications.

2. How does Zyclara compare to competitors like fluorouracil or ingenol mebutate?
While Zyclara offers a favorable safety profile and comparable efficacy, procedural treatments and newer topical agents with shorter courses or fewer side effects have challenged its market share.

3. What factors influence Zyclara’s declining revenues?
Key factors include patent expirations, generic competition, procedural preference shifts, side effect considerations, and reimbursement challenges.

4. Are there emerging therapeutic opportunities for Zyclara?
Potential exists in exploring off-label uses, combination therapies, or targeting niche indications where current options are inadequate. Further clinical research could unlock new markets.

5. What are the strategic considerations for stakeholders maintaining Zyclara’s market relevance?
Focus on clinical validation for additional indications, improving patient adherence, adjusting pricing strategies, and forging collaborations to innovate treatment paradigms.

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References

[1] American Academy of Dermatology Association. “Actinic Keratosis (AK).” Accessed 2023.