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Details for Patent: 8,299,109

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Patent 8,299,109 protects ZYCLARA and is included in one NDA. There have been two Paragraph IV challenges on Zyclara.

This patent has twenty patent family members in seventeen countries.

Summary for Patent: 8,299,109

Title:Method of treating actinic keratosis with 3.75% imiquimod cream
Abstract: Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available ALDARA 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration ("FDA"), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration ("FDA") for ALDARA 5% imiquimod cream to treat actinic keratosis are also disclosed and described.
Inventor(s): Nordsiek; Michael T. (Wayne, PA), Levy; Sharon F. (Philadelphia, PA), Lee; James H. (Devon, PA), Kulp; James H. (West Chester, PA), Balaji; Kodumudi S. (Lansdale, PA), Meng; Tze-Chiang (Lino Lakes, MN), Wu; Jason J. (Wayne, PA), Bahm; Valyn S. (Phoenixville, PA), Babilon; Robert (Boyertown, PA)
Assignee: Medicis Pharmaceutical Corporation (Scottsdale, AZ)
Application Number:13/182,433
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent Metrics:
Source: PatentQuant.com
Field: Basic materials chemistry
Back Citations: 32nd percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Medicis
ZYCLARA
imiquimod
CREAM;TOPICAL022483-001Mar 25, 2010RXYes8,299,109► subscribe TREATMENT OF ACTINIC KERATOSIS
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Non-Orange Book Patents for Patent: 8,299,109

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,236,8162.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod► subscribe
9,370,5092.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod► subscribe
8,222,2702.times.2.times.2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,299,109

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina074802► subscribe
Australia2009335943► subscribe
BrazilPI0923164► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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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