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Last Updated: October 21, 2019

DrugPatentWatch Database Preview

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-one patent family members in twenty-six 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 RX Yes Yes   Start Trial   Start Trial TREATMENT OF ACTINIC KERATOSIS   Start 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 8,236,816

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 074802   Start Trial
Australia 2009335943   Start Trial
Brazil PI0923164   Start Trial
Canada 2649893   Start Trial
Canada 2709732   Start Trial
Chile 2009002183   Start Trial
Colombia 6400171   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Johnson and Johnson
Boehringer Ingelheim
Medtronic
Dow

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