United Therapeutics advised of Watson ANDA filing for Tyvaso

15 June 2015

US biotech firm United Therapeutics (Nasdaq: UTHR) says it has received a Paragraph IV Certification Notice Letter from Watson Laboratories, advising that it has submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration requesting approval to market a generic version of Tyvaso (treprostinil) Inhalation Solution.

In the Notice Letter, Watson, which is part of Actavis and has now started trading as Allegan (NYSE: AGN) states that it intends to market a generic version of Tyvaso before the expiration of US Patent No 6,521,212, which expires in November 2018; US Patent 6,756,033, which expires in November 2018; and US Patent 8,497,393, which expires in December 2028. Tyvaso is a treatment of pulmonary arterial hypertension (PAH).

Challenge claims patents not valid

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