Imiquimod - Generic Drug Details

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What are the generic sources for imiquimod and what is the scope of freedom to operate?

Imiquimod is the generic ingredient in three branded drugs marketed by Bausch, Apotex Inc, Cosette, Encube, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Strides Pharma, and Taro, and is included in eleven NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imiquimod has fifty-eight patent family members in thirty-one countries.

There are fourteen drug master file entries for imiquimod. Eight suppliers are listed for this compound.

Summary for imiquimod

International Patents:	58
US Patents:	11
Tradenames:	3
Applicants:	9
NDAs:	11
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	172
Patent Applications:	6,703
Drug Prices:	Drug price trends for imiquimod
Drug Sales Revenues:	Drug sales revenues for imiquimod
What excipients (inactive ingredients) are in imiquimod?	imiquimod excipients list
DailyMed Link:	imiquimod at DailyMed

See drug prices for imiquimod

See drug sales revenues for imiquimod

Recent Clinical Trials for imiquimod

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

Sponsor	Phase
Medical University of Vienna	N/A
Northwestern University	Early Phase 1
Assiut University	Early Phase 1

See all imiquimod clinical trials

Pharmacology for imiquimod

Mechanism of Action	Interferon Inducers
Physiological Effect	Increased Cytokine Activity Increased Cytokine Production

Anatomical Therapeutic Chemical (ATC) Classes for imiquimod

D06BB	Antivirals
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for IMIQUIMOD

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
ALDARA	Cream	imiquimod	5%	020723	1	2006-10-17

US Patents and Regulatory Information for imiquimod

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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	022483-001	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
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-002	Jul 15, 2011		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

Expired US Patents for imiquimod

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997	⤷ Sign Up	⤷ Sign Up
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997	⤷ Sign Up	⤷ Sign Up
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for imiquimod

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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/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 imiquimod

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Country	Patent Number	Title	Estimated Expiration
Slovenia	2378876		⤷ Sign Up
Mexico	336923	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.)	⤷ Sign Up
Dominican Republic	P2011000195	FORMULACIONES DE IMIQUIMOD DE BAJA CONCENTRACION DE DOSIS Y REGIMENES DE DOSIS DE CORTA DURACION PARA TRATAR QUERATOSIS ACTINICA	⤷ Sign Up
Uruguay	32735	FORMULACIONES DE IMIQUIMOD DE CONCENTRACIÓN DE DOSIFICACIÓN INFERIOR Y REGÍMENES DE DOSIFICACIÓN CORTOS PARA TRATAR VERRUGAS GENITALES Y PERIANALES.	⤷ Sign Up
Israel	255163	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)	⤷ Sign Up
Argentina	077747	FORMULACIONES DE IMIQUIMOD DE CONCENTRACION DE DOSIFICACION INFERIOR Y REGIMENES DE DOSIFICACION CORTOS PARA TRATAR VERRUGAS GENITALES O PERIANALES	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for imiquimod

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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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