Item 8.01 Other Events.
On January 24, 2023, Intercept Pharmaceuticals, Inc. (the "Company") and its
subsidiary Intercept Pharma Europe Limited ("IPEL") (collectively, "Intercept")
entered into a settlement agreement with Amneal EU, Limited and Amneal
Pharmaceuticals of New York, LLC (collectively, "Amneal") resolving the
previously disclosed patent litigation concerning the submission by Amneal of an
Abbreviated New Drug Application ("ANDA") seeking approval to market a generic
version of Ocaliva® (obeticholic acid) 5 mg and 10 mg tablets prior to
expiration of the Company's Orange Book listed patents.
Under the terms of the agreement, Intercept granted Amneal a non-exclusive,
non-sublicensable, non-transferable, royalty-free license to commercialize its
generic version of Ocaliva in the United States commencing on April 26, 2034, or
earlier under certain circumstances. The parties will file the settlement
agreement with the Federal Trade Commission and the Department of Justice
pursuant to applicable law and will terminate their pending litigation pursuant
to a consent judgment that is subject to court approval. Similar patent
litigation previously disclosed by the Company against other ANDA filers seeking
approval to market generic Ocaliva remains pending.
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