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Last Updated: April 25, 2024

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 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. Nine 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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Summary for ZYCLARA
Drug patent expirations by year for ZYCLARA
Drug Prices for ZYCLARA

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Drug Sales Revenue Trends for ZYCLARA

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Recent Clinical Trials for ZYCLARA

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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 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ACTINIC KERATOSIS

Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GENITAL WARTS

Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PERIANAL WARTS

Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GENITAL WARTS

Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PERIANAL WARTS

Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PERIANAL WARTS

Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GENITAL WARTS

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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PERIANAL WARTS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ACTINIC KERATOSIS

Method of treating actinic keratosis with 3.75% imiquimod cream
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ACTINIC KERATOSIS

Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GENITAL WARTS

Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-002 Jul 15, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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.

Country Patent Number Title Estimated Expiration
Israel 213628 פורמולציות של אימיקווימוד בעוצמה של מינון נמוך ומשטר מינוני קצר לטיפול בקרטוזיס אקטיני (Lower dosage strength imiquimod formulations and short dosing regimens for treating actinic keratosis) ⤷  Try a Trial
Spain 2720149 ⤷  Try a Trial
Dominican Republic P2011000195 FORMULACIONES DE IMIQUIMOD DE BAJA CONCENTRACION DE DOSIS Y REGIMENES DE DOSIS DE CORTA DURACION PARA TRATAR QUERATOSIS ACTINICA ⤷  Try a Trial
Georgia, Republic of P20156418 LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS ⤷  Try a Trial
Uruguay 32375 FORMULACIONES DE IMIQUIMOD DE BAJA CONCENTRACIÓN DE DOSIS Y REGIMENES DE DOSIS DE CORTA DURACIÓN PARA TRATAR QUERATOSIS ACTÍNICA ⤷  Try a Trial
>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 ⤷  Try a Trial 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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