Auxilium Pharmaceuticals, Inc.
Xstelos Holdings, Inc.
) recently received a notice from Upsher-Smith Laboratories, Inc.
regarding the filing of a 505(b)(2) new drug application
(NDA) for Auxilium Pharma's 1% testosterone gel, Testim.
The 505(b)(2) NDA contains a paragraph IV certification under
21 U.S.C. Section 314.52(c). The company is challenging ten US
patents which are slated to expire in the 2023-2025
We note in April 2012,
) also challenged Testim's patents. Auxilium Pharma has filed a
patent infringement lawsuit against Watson.
Testim is the lead product at Auxilium Pharma, 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.
Testim's share of total prescriptions for the gel segment of
the testosterone replacement therapy (TRT) market was 20% in
2011, down from 22% in the year-ago period. The TRT gel market is
growing at a slower rate and this will affect sales going
Apart from this, the TRT market is highly competitive with the
) Fortesta and
The testosterone gel market will become even more competitive
from 2015 when generic versions of AndroGel 1% are scheduled to
enter the market. The availability of a cheaper generic
testosterone gel product could impact Testim's market share as
well as its formulary status.
In this scenario, the sooner-than-expected entry of a generic
version would be a major blow for the company.
Auxilium Pharma currently carries a Zacks #3 Rank (Hold).
Currently, pharma stocks which look more attractive are
Valeant Pharmaceuticals International, Inc.
Ironwood Pharmaceuticals, Inc.
). Both carry a Zacks #1 Rank (Strong Buy).
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