) shares slipped 1.29% on news that
) has filed an Abbreviated New Drug Application (ANDA) for its
generic version of Allergan's eye drug, Restasis.
The paragraph IV filing is challenging U.S. patent number
8,629,111 which is slated to expire in Aug 2024. A method of use
patent (patent number 8,633,162) for Restasis was issued recently
by the United States Patent and Trademark Office - this patent,
which has been submitted for listing in the Orange Book, is also
slated to expire in Aug 2024.
Actavis had submitted the ANDA before the FDA had issued
bioequivalence draft guidelines in Jun 2013 related to the
approval of generic versions of Restasis. According to the draft
guidelines, companies wanting to make a generic version of
Restasis have two options - an in vitro study or an in vivo
study. These draft guidelines, if finalized, could make it easier
for generic versions of Restasis to enter the market.
Since Actavis had submitted its ANDA before the issuance of
the FDA guidelines, the FDA informed Actavis that it would not
accept the ANDA filing. Actavis is currently in discussions with
the agency regarding the status of its ANDA filing. Actavis also
amended its ANDA in order to include a para IV certification
regarding the recently issued patent '162.
Restasis posted sales of $662.4 million in the first nine
months of 2013.
Although Allergan's shares slipped slightly on the news
regarding Actavis' ANDA, we do not expect generic competition to
enter the market any time soon. The issuance of new patents
should provide protection. Moreover, Allergan has submitted a
Citizen Petition to the FDA regarding the agency's draft guidance
for Restasis. Also, there is lack of clarity on the filing status
of Actavis' ANDA.
While Actavis is a Zacks Rank #1 (Strong Buy) stock, Allergan
is a Zacks Rank #2 (Buy) stock. Other stocks in the medical
sector that look attractive include
Impax Laboratories Inc.
H. Lundbeck A/S
). Both are Zacks Rank #1 stocks.
ACTAVIS PLC (ACT): Free Stock Analysis Report
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