Auxilium Pharmaceuticals, Inc.
) recently announced the initiation of a patent infringement
lawsuit against Upsher-Smith Laboratories, Inc. which is looking
to launch its generic version of Testim, 1% testosterone gel.
Upsher-Smith has challenged ten patents that are listed in the
Orange Book and which are slated to expire between Apr 21, 2023
and Jan 18, 2025.
The filing of the patent infringement lawsuit within 45 days
from the date of receipt of notice from Upsher-Smith is in line
with our expectations. This will ensure that the FDA cannot grant
final approval to Upsher-Smith's generic for up to 30 months (Jun
24, 2015) or the court's decision, whichever is earlier.
We note that Auxilium Pharma is already facing a patent
challenge for Testim. In Apr 2012,
) had challenged Testim's patents. Auxilium Pharma has filed a
patent infringement lawsuit against Actavis.
Testim, the lead product at Auxilium Pharma is approved for
the treatment of hypogonadism or low testosterone level. Testim
sales came in at $55.4 million in the third quarter of 2012,
accounting for 78% of the company's revenues. The entry of a
generic version would be a major blow for the company.
Auxilium Pharma is currently working on boosting Testim sales.
The company has a co-promotion agreement with
) for Testim. With urology being a key focus area at Glaxo,
Testim sales should benefit from the additional promotional
effort. Moreover, it has been seen that testosterone replacement
therapies (TRTs) are sensitive to promotional efforts. Glaxo's
sales force started promoting Testim from Jul 2012.
Auxilium Pharma currently carries a Zacks #3 Rank (Hold).
), which carries a Zacks Rank #1 (Strong Buy), looks more
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