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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
September 17, 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
(State of Incorporation)
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001-14471
(Commission File Number)
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52-1574808
(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:
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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 September 17, 2010, Medicis Pharmaceutical Corporation (the Company) received an
additional 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 generic SOLODYN® in its forms of 45mg, 65mg, 90mg,
115mg and 135mg strengths. Lupins Paragraph IV Certification alleges that the Companys newly
issued U.S. Patent No. 7,790,705 (the 705 Patent), which was issued to the Company by the U.S.
Patent and Trademark Office on September 7, 2010, will not be infringed by Lupins manufacture,
use, sale and/or importation of the products for which the ANDA Supplement/Amendment was submitted.
As previously reported, the Company has previously received Paragraph IV Certifications in
connection with the ANDA from Lupin relating to certain of the Companys other patents related to
SOLODYN, including the Companys U.S. Patent No. 5,908,838. 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 patent is 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: September 21, 2010 |
By: |
/s/ Jason D. Hanson
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Jason D. Hanson |
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Executive Vice President, Chief Operating
Officer, Acting General Counsel and Corporate
Secretary |
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