ZYCLARA Drug Patent Profile

Name: ZYCLARA Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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-nine patent family members in thirty-two 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:	59
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	10
Drug Prices:	Drug price information for ZYCLARA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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.

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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	8,222,270	⤷ Start Trial				⤷ Start Trial
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	8,598,196	⤷ Start Trial				⤷ Start Trial
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	10,238,645	⤷ Start Trial				⤷ Start 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

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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/000179Imiquimod 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/002387Zyclara 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/000180Imiquimod 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
Argentina	074802		⤷ Start Trial
Australia	2009335943		⤷ Start Trial
Brazil	PI0923164		⤷ Start Trial
>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	⤷ Start Trial	PRODUCT NAME: IMIQUIMOD; REGISTERED: UK EU/1/98/080/001 19980918
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

DrugChatter Q&A for ZYCLARA

Zyclara imiquimod cream 3 75 price?
Is zyclara the same as imiquimod?