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Last Updated: October 18, 2021

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Details for Patent: 10,238,644


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Which drugs does patent 10,238,644 protect, and when does it expire?

Patent 10,238,644 protects ZYCLARA and is included in one NDA.

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

Summary for Patent: 10,238,644
Title:2.times.2.times.2 week dosing regimen for treating acting 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.RTM. 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.RTM. 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 Hurn-Joung (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 (Bridgewater, NJ)
Application Number:15/187,751
Patent Claim Types:
see list of patent claims
Use; Composition;

Drugs Protected by US Patent 10,238,644

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 ⤷  Free Forever Trial ⤷  Free Forever Trial TREATMENT OF ACTINIC KERATOSIS ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,238,644

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 074802 ⤷  Free Forever Trial
Australia 2009335943 ⤷  Free Forever Trial
Brazil PI0923164 ⤷  Free Forever Trial
Canada 2649893 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Boehringer Ingelheim

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