Item 8.01. Other Events
On October 24, 2008, we publicly disseminated a press release announcing
that Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and we have received a notice
from Upsher-Smith Laboratories advising of the filing by Upsher-Smith
Laboratories of an Abbreviated New Drug Application (ANDA) containing a
Paragraph IV certification under 21 U.S.C. Section 355(j) for testosterone gel.
The certification notice states that Upsher-Smith does not believe that the
product for which it is seeking approval infringes CPEX's U.S. Patent
No. 7,320,968, which covers Testim̉1% testosterone gel. This patent is listed in
Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known
as the Orange Book), published by the U.S. Food and Drug Administration, and
will expire in January 2025.
The foregoing description is qualified in its entirety by reference to our
press release dated October 24, 2008, a copy of which is attached hereto as
Exhibit 99.1 and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits
Exhibit Exhibit Title
Exhibit 99.1 Press Release dated October 24, 2008