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Serving leading biopharmaceutical companies globally:

Healthtrust
US Army
Chinese Patent Office
Express Scripts
Moodys
AstraZeneca
Cantor Fitzgerald
Mallinckrodt
UBS
Harvard Business School

Generated: February 23, 2018

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 twenty-one patent family members in seventeen 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 Patent Submitted
Medicis ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up TREATMENT OF ACTINIC KERATOSIS ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 8,236,816

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
8,222,270 2.times.2.times.2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod ➤ Sign Up
8,299,109 Method of treating actinic keratosis with 3.75% imiquimod cream ➤ Sign Up
9,370,509 2.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,236,816

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 074802 ➤ Sign Up
Australia 2009335943 ➤ Sign Up
Brazil PI0923164 ➤ Sign Up
Canada 2649893 ➤ Sign Up
Canada 2709732 ➤ Sign Up
Colombia 6400171 ➤ Sign Up
Costa Rica 20110338 ➤ Sign Up
Dominican Republic P2011000195 ➤ Sign Up
Eurasian Patent Organization 201100984 ➤ Sign Up
European Patent Office 2378876 ➤ Sign Up
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Boehringer Ingelheim
Baxter
McKinsey
UBS
Fish and Richardson
Chinese Patent Office
Johnson and Johnson
Julphar

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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