Allergan Files ANDA for Generic Version of Tyvaso(r)

Strategic Insights -

Allergan, a multinational pharmaceutical company, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Tyvaso(r), a treatment for pulmonary arterial hypertension (PAH). The move comes as United Therapeutics, the manufacturer of Tyvaso(r), has filed a lawsuit against Allergan, alleging that the company's ANDA product infringes on certain U.S. Patents. The case is pending in the U.S. District Court for the District of New Jersey.

Key Takeaways:

  • Allergan has filed an ANDA with the FDA for a generic version of Tyvaso(r), a treatment for PAH.
  • United Therapeutics has filed a lawsuit against Allergan, alleging patent infringement.
  • The lawsuit was filed under the Hatch-Waxman Act, resulting in a stay of final FDA approval of Allergan's ANDA for up to 30 months.
  • Allergan may be entitled to 180 days of generic market exclusivity if its ANDA is approved.
  • The 12-month sales data for Tyvaso(r) in the US is around $463 million for the year ending December 31, 2014.

Statistics:

  • 30 months: The maximum time period for which FDA approval of Allergan's ANDA can be stayed.
  • 180 days: The generic market exclusivity period that Allergan may be entitled to if its ANDA is approved.
  • $463 million: The 12-month sales data for Tyvaso(r) in the US for the year ending December 31, 2014.

Sources:

  • Allergan plc (2015, July 22). United Therapeutics files suit against Allergan regarding Tyvaso(r). PR Newswire.