Acura Pharmaceuticals, Inc.
) entered into a settlement agreement with
Impax Laboratories, Inc.
) and Par Pharmaceutical Companies, Inc. to resolve their patent
litigation regarding Oxecta. Par was acquired by TPG Capital in
Oxecta is approved to manage the acute and chronic moderate to
severe pain where the use of an opioid analgesic is
With the litigation being settled, Par can now sell its
generic version of Oxecta in the U.S. on Jan 1, 2022 or before
under certain circumstances. Par's launch of generic Oxecta
depends on Acura's grant of a non-exclusive, royalty-bearing
license to Par. Par being the first Abbreviated New Drug
Application filer for generic Oxecta is entitled to a 180-day
exclusivity. Acura is entitled to get royalties of 10%-15% of
Par's net profits from generic Oxecta sales.
As per the agreement, Impax can sell its generic version of
Oxecta in the U.S. through the grant of a non-exclusive,
royalty-free license from Acura. This will be effective 180 days
after the first sale of a generic Oxecta in the U.S. or before
under certain circumstances.
Meanwhile, other generic companies including Ranbaxy and
) are also seeking approval from the FDA to sell their generic
version of Oxecta. Patent litigation against them is pending in
the U.S. District Court. Acura has challenged the
applications from these companies alleging infringement of U.S.
patent no. 7,510,726, expiring in Nov 2023.
Acura currently carries a Zacks Rank #4 (Sell). Other
companies that look well-positioned include Impax and
). While Actelion carries a Zacks Rank #1 (Strong Buy), Impax
carries a Zacks Rank #2 (Buy).
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