ZYCLARA Drug Patent Profile

Which patents cover Zyclara, 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-eight patent family members in thirty-one 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:	58
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	10
Patent Applications:	4,433
Drug Prices:	Drug price information 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
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-002	Jul 15, 2011		RX	Yes	Yes
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes

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/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 ZYCLARA

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

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)
Hungary	E041944
Dominican Republic	P2011000195	FORMULACIONES DE IMIQUIMOD DE BAJA CONCENTRACION DE DOSIS Y REGIMENES DE DOSIS DE CORTA DURACION PARA TRATAR QUERATOSIS ACTINICA

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

ZYCLARA Market Analysis and Financial Projection Experimental

Actinic Keratosis Treatment Market and ZYCLARA: Market Dynamics and Financial Trajectory

Introduction to Actinic Keratosis and ZYCLARA

Actinic keratosis (AK) is a common skin condition caused by prolonged exposure to the sun, leading to the formation of small, rough, scaly patches on the skin. ZYCLARA, an imiquimod cream, is a widely used treatment for actinic keratosis, particularly on the face or balding scalp.

Market Size and Growth

The global actinic keratosis treatment market is experiencing significant growth. As of 2022, the market size was estimated at USD 6.4 billion and is anticipated to grow at a compound annual growth rate (CAGR) of 4.3% from 2023 to 2030[1].

Segmentation and Revenue Share

The market is segmented based on drug class, with nucleoside metabolic inhibitors, NSAIDs, immune response modifiers, photoenhancers, and others being key categories. Immune response modifiers, which include ZYCLARA, are crucial in this market. In 2022, nucleoside metabolic inhibitors held the largest revenue share of 32.4%, but immune response modifiers like ZYCLARA also play a significant role[1].

ZYCLARA: A Key Player in the Market

ZYCLARA, manufactured by Bausch Health Companies Inc., is an immune response modifier used to treat actinic keratosis. It is available in 2.5% and 3.75% cream formulations. The product's effectiveness and widespread use contribute to its significant market presence.

Usage and Side Effects

ZYCLARA works by stimulating the body's immune system to fight off the abnormal skin cells that cause actinic keratosis. Common side effects include erythema, scabbing/crusting, edema, and erosion/ulceration, which are generally mild to moderate but can be severe in some cases[4].

Regional Market Dynamics

North America

North America dominated the actinic keratosis treatment market with a 41.5% revenue share in 2022. This dominance is attributed to the high prevalence of actinic keratosis, favorable government initiatives, rising consumer awareness, and advanced healthcare infrastructure[1].

Asia Pacific

The Asia Pacific region is expected to grow at the fastest CAGR of 5.6% during the forecast period. Factors such as increasing adoption of treatments, rising disposable incomes, and high disease prevalence in countries like Australia and New Zealand drive this growth[1].

Financial Performance and Projections

Market Growth Projections

The actinic keratosis treatment market is projected to expand significantly, with sales expected 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].

Company Performance

Bausch Health Companies Inc., the manufacturer of ZYCLARA, operates within a highly competitive market. The company's financial performance is influenced by the overall market dynamics, including the demand for topical treatments and the competitive landscape. While specific financial data for ZYCLARA is not isolated, the overall performance of Bausch Health Companies Inc. reflects the market trends and consumer demand for dermatological treatments.

Strategic Initiatives and Awareness

Industry players, including Bausch Health Companies Inc., are undertaking various strategic initiatives to boost market growth. For example, collaborations with universities and awareness campaigns, such as Actinic Keratosis Global Day, help increase consumer awareness and drive the adoption of treatments like ZYCLARA[1].

Homecare Segment Growth

The homecare segment, which includes topical products like ZYCLARA, is expected to grow at the fastest CAGR of 5.2% during the forecast period. This growth is driven by patient convenience, the availability of over-the-counter (OTC) products, and the increasing launch of topical treatments[1].

Competitive Landscape

The actinic keratosis treatment market is highly competitive, with numerous industry players. Companies like Hill Dermaceuticals, Inc., and Almirall S.A. are also making significant strides in the market through product launches and research collaborations. This competitive environment drives innovation and growth in the market[1].

Key Takeaways

• Market Growth: The actinic keratosis treatment market is expected to grow significantly, driven by increasing prevalence and awareness.
• ZYCLARA's Role: As an immune response modifier, ZYCLARA plays a crucial role in the treatment of actinic keratosis.
• Regional Dynamics: North America and Asia Pacific are key regions driving market growth.
• Financial Projections: The market is projected to double in size by 2034, with a CAGR of 7.2%.
• Strategic Initiatives: Industry players are focusing on awareness campaigns and strategic collaborations to boost market growth.

FAQs

1. What is the current market size of the actinic keratosis treatment market? The global actinic keratosis treatment market size was estimated at USD 6.4 billion in 2022[1].

2. What is the expected CAGR of the actinic keratosis treatment market from 2023 to 2030? The market is anticipated to grow at a CAGR of 4.3% from 2023 to 2030[1].

3. What are the common side effects of ZYCLARA? Common side effects include erythema, scabbing/crusting, edema, and erosion/ulceration[4].

4. Which region is expected to grow at the fastest CAGR in the actinic keratosis treatment market? The Asia Pacific region is expected to grow at the fastest CAGR of 5.6% during the forecast period[1].

5. What is the projected market size of the actinic keratosis treatment market by 2034? The market is projected to reach USD 12,282.4 million by 2034, growing at a CAGR of 7.2% from 2024 to 2034[3].

Cited Sources

1. Grand View Research: Actinic Keratosis Treatment Market Size, Share Report, 2030.
2. Biospace: Zyla Life Sciences Reports Second Quarter 2019 Financial Results.
3. Future Market Insights: Actinic Keratosis Treatment Market Analysis & Opportunity 2034.
4. RxList: Zyclara (Imiquimod Cream): Side Effects, Uses, Dosage.
5. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.