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. 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 25th, 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 |
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 |
Pharmacology for ZYCLARA
| Mechanism of Action | Interferon Inducers |
| Physiological Effect | Increased Cytokine Activity Increased Cytokine Production |
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: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GENITAL WARTS
Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PERIANAL WARTS
Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GENITAL WARTS
Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PERIANAL WARTS
Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PERIANAL WARTS
Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GENITAL WARTS
2x2x2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75% imiquimod
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACTINIC KERATOSIS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PERIANAL WARTS
Patent Number: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACTINIC KERATOSIS
Method of treating actinic keratosis with 3.75% imiquimod cream
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACTINIC KERATOSIS
Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GENITAL WARTS
Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ 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
| 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 |
|---|---|---|---|
| Cyprus | 1121485 | ⤷ Sign Up | |
| Chile | 2010000524 | Uso de una composición tópica que comprende 3,75% de imiquimod y un portador farmacéuticamente aceptable para preparar un medicamento útil para tratar verrugas genitales o perianales. | ⤷ Sign Up |
| Uruguay | 32375 | FORMULACIONES DE IMIQUIMOD DE BAJA CONCENTRACIÓN DE DOSIS Y REGIMENES DE DOSIS DE CORTA DURACIÓN PARA TRATAR QUERATOSIS ACTÍNICA | ⤷ Sign Up |
| Costa Rica | 20120068 | FORMULACIONES DE IMIQUIMOD DE CONCENTRACIÓN DE DOSIFICACIÓN INFERIOR Y REGÍMENES DE DOSIFICACIÓN CORTOS PARA TRATAR VERRUGAS GENITALES Y PERIANALES | ⤷ Sign Up |
| Peru | 20142367 | FORMULACIONES DE IMIQUIMOD | ⤷ Sign Up |
| Peru | 20100469 | FORMULACIONES DE IMIQUIMOD | ⤷ Sign Up |
| >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 | ⤷ Sign Up | 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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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.
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