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
October 26, 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 |
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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
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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 a Paragraph IV Patent Certification from Aurobindo Pharma Limited
On October 26, 2010, Medicis Pharmaceutical Corporation (the Company) received a
Paragraph IV Patent Certification from Aurobindo Pharma Limited (Aurobindo) advising that
Aurobindo has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug
Administration (FDA) for generic versions of SOLODYN® (minocycline HCl, USP) Extended Release
Tablets in 45mg, 65mg, 90mg, 115mg and 135mg strengths. Aurobindo has not advised the Company as
to the timing or status of the FDAs review of its filing, or whether it has complied with FDA
requirements for proving bioequivalence. Aurobindos Paragraph IV Certification alleges that the
Companys U.S. Patent No. 5,908,838 (the 838 Patent) is invalid. The expiration date for the
838 Patent is in 2018. Aurobindos Paragraph IV Certification also alleges that the Companys
U.S. Patent Nos. 7,541,347 (the 347 Patent), 7,544,373 (the 373 Patent) and 7,790,705 (the
705 Patent) are not infringed by Aurobindos manufacture, importation, use, sale and/or offer
for sale of the products for which the ANDA was submitted. The expiration dates for the 347 and
373 Patents are in 2027, and the expiration date for the 705 Patent is in 2025 or later. The
Company is evaluating the details of Aurobindos certification letter and considering its options.
The Company Receives a Paragraph IV Patent Certification from Ranbaxy Laboratories Limited
On October 27, 2010, the Company received a Paragraph IV Patent Certification from
Ranbaxy Laboratories Limited (Ranbaxy) advising that Ranbaxy has filed a supplement or amendment
to its earlier filed ANDA assigned ANDA number 91-118 (ANDA Supplement/Amendment) with the FDA
for a generic version of SOLODYN in 80mg strength. Ranbaxy has not advised the Company as to the
timing or status of the FDAs review of its filing, or whether Ranbaxy has complied with FDA
requirements for proving bioequivalence. Ranbaxys Paragraph IV Certification alleges that the838
Patent and the 705 Patent will not be infringed by Ranbaxys manufacture, importation, use, sale
and/or offer for sale of the products for which the ANDA Supplement/Amendment was submitted because
Ranbaxy 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: November 1, 2010 |
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/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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