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Last Updated: May 19, 2022

ZYCLARA Drug Patent Profile


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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 eight 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. Seven 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 25th, 2010.

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Drug patent expirations by year for ZYCLARA
Drug Prices for ZYCLARA

See drug prices for ZYCLARA

Drug Sales Revenue Trends for ZYCLARA

See drug sales revenues for ZYCLARA

Recent Clinical Trials for ZYCLARA

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

SponsorPhase
Aalborg UniversityN/A
National Cancer Institute (NCI)Early Phase 1
Melissa Pugliano-MauroPhase 1

See all ZYCLARA clinical trials

Pharmacology for ZYCLARA
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 twelve 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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACTINIC KERATOSIS

Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF GENITAL WARTS

Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PERIANAL WARTS

Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF GENITAL WARTS

Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PERIANAL WARTS

Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PERIANAL WARTS

Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACTINIC KERATOSIS

Method of treating actinic keratosis with 3.75% imiquimod cream
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACTINIC KERATOSIS

Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF GENITAL WARTS

Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PERIANAL WARTS

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ZYCLARA

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

Country Patent Number Title Estimated Expiration
European Patent Office 2453747 FORMULATIONS D'IMIQUIMOD À INTENSITÉ DE DOSAGE PLUS FAIBLE ET RÉGIMES POSOLOGIQUES COURTS POUR TRAITER DES VERRUES GÉNITALES ET PÉRIANALES (LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS) See Plans and Pricing
Peru 20110064 FORMULACIONES DE IMIQUIMOD DE 3,75% EN PESO See Plans and Pricing
Eurasian Patent Organization 201100984 КОМПОЗИЦИИ С БОЛЕЕ НИЗКИМ СОДЕРЖАНИЕМ ИМИКВИМОДА И КОРОТКИЕ РЕЖИМЫ ДОЗИРОВАНИЯ ДЛЯ ЛЕЧЕНИЯ АКТИНИЧЕСКОГО КЕРАТОЗА See Plans and Pricing
Australia 2010274097 Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts See Plans and Pricing
Peru 20100469 FORMULACIONES DE IMIQUIMOD See Plans and Pricing
Lithuania 2378876 See Plans and Pricing
Brazil PI0923164 formulações de imiquimod com concentração de dosagem menos e regimes de dosagem curtos para o tratamento de ceratose actínica. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZYCLARA

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

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Express Scripts
AstraZeneca
Baxter
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.