UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
December 27, 2010
Date of Report (Date of earliest event reported)
Medicis Pharmaceutical Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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001-14471
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52-1574808 |
(State of Incorporation)
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(Commission File Number)
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(IRS Employer
Identification Number) |
7720 North Dobson Road
Scottsdale, Arizona 85256
(Address of principal executive offices) (Zip Code)
(602) 808-8800
(Registrants telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 8.01 Other Events.
The Company Receives Paragraph IV Patent Certifications from Sandoz Inc.
On December 27, 2010, and December 29, 2010, Medicis Pharmaceutical Corporation (the
Company) received Paragraph IV Patent Certifications from Sandoz Inc. (Sandoz) advising that
Sandoz has filed supplements or amendments to its earlier filed Abbreviated New Drug Application
(ANDA) assigned ANDA number 91-422 (ANDA Supplements/Amendments) with the U.S. Food and Drug
Administration (FDA) for generic versions of SOLODYN® (minocycline HCl,
USP) Extended Release Tablets in 55mg strength, and in 80mg and 105mg strengths, respectively.
Sandoz has not advised the Company as to the timing or status of the FDAs review of its filings,
or whether Sandoz has complied with FDA requirements for proving bioequivalence. Sandozs
Paragraph IV Certifications allege that the Companys U.S. Patent Nos. 5,908,838 (the 838
Patent) and 7,790,705 (the 705 Patent) will not be infringed by Sandozs manufacture,
importation, use, sale and/or offer for sale of the products for which the ANDA
Supplements/Amendments were submitted because Sandoz has a licensing agreement with the Company.
The expiration date for the 838 Patent is in 2018, and the expiration date for the 705 Patent is
in 2025 or later.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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Medicis Pharmaceutical Corporation
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Date: January 3, 2011 |
By: |
/s/ Seth L. Rodner
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Seth L. Rodner |
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Senior Vice President, General Counsel and
Corporate Secretary |
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