ZYCLARA Drug Patent Profile

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Which patents cover Zyclara, and what generic alternatives are available?

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.

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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:	3,919
Drug Prices:	Drug price information for ZYCLARA
What excipients (inactive ingredients) are in ZYCLARA?	ZYCLARA excipients list
DailyMed Link:	ZYCLARA at DailyMed

Drug patent expirations by year 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.

Patents protecting ZYCLARA

2.times.2.times.2 week dosing regimen for treating acting keratosis with pharmaceutical compositions formulated with 3.75% imiquimod
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACTINIC KERATOSIS

Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
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Patented Use: TREATMENT OF GENITAL WARTS

Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
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Patented Use: TREATMENT OF PERIANAL WARTS

2x2x2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75% imiquimod
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACTINIC KERATOSIS

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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PERIANAL WARTS

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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GENITAL WARTS

2.times.2.times.2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACTINIC KERATOSIS

2.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACTINIC KERATOSIS

Method of treating actinic keratosis with 3.75% imiquimod cream
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Patented Use: TREATMENT OF ACTINIC KERATOSIS

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-002	Jul 15, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for ZYCLARA

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ZYCLARA

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

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Country	Patent Number	Title	Estimated Expiration
Ukraine	108854	КОМПОЗИЦІЇ З БІЛЬШ НИЗЬКИМ ВМІСТОМ ІМІКВІМОДУ ТА КОРОТКІ РЕЖИМИ ДОЗУВАННЯ ДЛЯ ЛІКУВАННЯ ГЕНІТАЛЬНИХ І ПЕРІАНАЛЬНИХ БОРОДАВОК	⤷ Sign Up
South Africa	201301397	LOWER DOSAGE STRENGHT IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS	⤷ Sign Up
Panama	8855101	FORMULACIONES DE IMIQUIMOD DE MENOR POTENCIA DE DOSIFICACIÓN Y REGÍMENES DE DOSIFICACIÓN CORTOS PARA TRATAR QUERATOSIS ACTÍNICA	⤷ Sign Up
Taiwan	201105668	Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts	⤷ Sign Up
Taiwan	201040173	Lower dosage strength imiquimod formulations and short dosing regimens for treating actinic keratosis	⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ZYCLARA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0145340	SPC/GB99/003	United Kingdom	⤷ Sign Up	PRODUCT NAME: IMIQUIMOD; REGISTERED: UK EU/1/98/080/001 19980918
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description