Item 8.01 Other Events.
In November and December 2022, Jazz Pharmaceuticals plc (the "Company") received
notices from Teva Pharmaceuticals, Inc.; Padagis US LLC; Apotex Inc.; API Pharma
Tech LLC and InvaGen Pharmaceuticals, Inc.; Lupin Limited; Taro Pharmaceutical
Industries Ltd.; Zenara Pharma Private Limited and Biophore Pharma, Inc.; MSN
Laboratories Pvt. Ltd. and MSN Pharmaceuticals, Inc.; Alkem Laboratories Ltd.;
and Ascent Pharmaceuticals, Inc. (the "ANDA Filers"), that they have each filed
with the U.S. Food and Drug Administration ("FDA") an Abbreviated New Drug
Application ("ANDA"), for a generic version of Epidiolex® (cannabidiol) oral
solution. As of the date of this filing, we are not aware of other ANDA filers.
The notices from the ANDA Filers each included a "paragraph IV certification"
with respect to certain of the Company's patents listed in FDA's Orange Book for
Epidiolex on the date of the receipt of the notice. The listed patents relate
generally to the composition and method of use of Epidiolex, and methods of
treatment using Epidiolex. A paragraph IV certification is a certification by a
generic applicant that alleges that patents covering the branded product are
invalid, unenforceable, and/or will not be infringed by the manufacture, use or
sale of the generic product.
On January 3, 2023, the Company filed a patent infringement suit against the
ANDA Filers in the United States District Court for the District of New Jersey.
The complaint alleges that by filing their ANDAs, the ANDA Filers have infringed
certain of the Company's Orange Book listed patents, and seeks an order that the
effective date of FDA approval of the ANDAs shall be a date no earlier than the
expiration of the last to expire of the asserted patents. As a result of this
lawsuit, a stay of approval of up to 30 months will be imposed by FDA on the
ANDA Filers' ANDAs. Epidiolex also has Orphan Drug Exclusivity for the treatment
of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in
patients 2 years of age and older through September 28, 2025 and for the
treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
in patients between 1 and 2 years of age and for the treatment of seizures
associated with tuberous sclerosis complex through July 31, 2027.
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