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
January 24, 2011
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
(State of Incorporation)
Identification Number)
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001-14471
(Commission File Number)
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52-1574808
(IRS Employer |
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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The Company Receives a Paragraph IV Patent Certification from Lupin Ltd.
On January 24, 2011, Medicis Pharmaceutical Corporation (the Company) received a Paragraph
IV Patent Certification from Lupin Ltd. (Lupin), advising that Lupin has filed a supplement or
amendment to its earlier filed Abbreviated New Drug Application (ANDA) assigned ANDA number
91-424 (ANDA Supplement/Amendment) with the U.S. Food and Drug Administration (FDA) for a
generic version of SOLODYN® (minocycline HCl, USP) Extended Release Tablets in 105mg strength.
Lupin has not advised the Company as to the timing or status of the FDAs review of its filing, or
whether Lupin has complied with FDA requirements for proving bioequivalence. Lupins Paragraph IV
Certification alleges that the Companys U.S. Patent No. 5,908,838 (the 838 Patent) is invalid.
Lupins Paragraph IV Certification also alleges that the Companys U.S. Patent No. 7,790,705 (the
705 Patent) will not be infringed by Lupins manufacture, use, sale and/or importation of the
products for which the ANDA Supplement/Amendment was submitted. The expiration date for the 838
Patent is in 2018 and the expiration date for the 705 Patent is in 2025 or later. The Company is
evaluating the details of Lupins certification letter and considering its options. Lupins
submission amends an ANDA already subject to a 30-month stay. As such, the Company believes that
the amendment cannot be approved by the FDA until after the expiration of the 30-month period or a
court decision that the patents are invalid or not infringed.
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 26, 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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