United Therapeutics Corporation
) recently announced that the US Food and Drug Administration
(FDA) has accepted its new drug application (NDA) for oral
Remodulin (treprostinil) that was re-submitted by the company
following the receipt of a complete response letter (CRL) from
the FDA in Oct 2012. United Therapeutics is looking to get oral
Remodulin approved for the treatment of pulmonary arterial
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The FDA is treating the resubmitted NDA as a complete, class 1
response and will respond to the application by Mar 31, 2013.
We note that United Therapeutics is facing a patent challenge for
Remodulin (treprostinil) injection. Sandoz is seeking approval
for its generic version of Remodulin (10 mg/mL). United
Therapeutics has filed a patent infringement lawsuit against
Sandoz. Remodulin, the key revenue generator at United
Therapeutics, accounts for almost 50% of sales.
United Therapeutics currently carries a Zacks Rank #1 (Strong
Buy). The company is well-positioned to gain share in the
pulmonary arterial hypertension market. Remodulin continues to
look very strong in both the intravenous (IV) and subcutaneous
With the approval of Adcirca and Tyvaso, United Therapeutics has
a varied range of therapies available for the treatment of
pulmonary arterial hypertension. We believe the company's
pulmonary arterial hypertension product portfolio will drive
strong top-and bottom-line growth.
Other players in the pulmonary arterial hypertension market
include companies like
) among others. We believe competition will continue to increase
with several companies working on bringing additional therapies
to the market.
Another company that currently looks well-positioned is
). Valeant is also a Zacks Rank #1 stock.