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Last Updated: July 25, 2021

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Details for Patent: 8,236,816


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Which drugs does patent 8,236,816 protect, and when does it expire?

Patent 8,236,816 protects ZYCLARA and is included in one NDA.

This patent has thirty-four patent family members in twenty-nine countries.

Summary for Patent: 8,236,816
Title:2.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod
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:13/181,499
Patent Claim Types:
see list of patent claims
Use; Composition;

Drugs Protected by US Patent 8,236,816

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free TREATMENT OF ACTINIC KERATOSIS ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Dow
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Harvard Business School

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