You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 18, 2024

ZYCLARA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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.

  Try a Trial

Summary for ZYCLARA
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 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
Mexico 2011001410 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.) ⤷  Try a Trial
Spain 2653313 ⤷  Try a Trial
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
Cyprus 1121485 ⤷  Try a Trial
Slovenia 2378876 ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

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.