Both Roxane Laboratories and Par Pharmaceuticals re-launched their generic versions of GlaxoSmithKline’s Flonase product for allergic rhinitis, following the expiry of a temporary restraining order on the distribution of the products.
On Monday, a Baltimore court denied GSK's motion for a preliminary injunction to set aside the US Food and Drug Administration's (FDA) final decision approving Roxane’s generic version of Flonase (fluticasone propionate), which achieved sales close to $900 million in the USA last year.
Par was able to re-launch its product under the terms of a licensing agreement with GSK, which gives it 'authorised generic' status. This deal made it possible for Par to enter the market once another generic version of Flonase was introduced.
The total US market for intranasal corticosteroids used in allergic rhinitis is valued at around $2.6 billion in the USA.
Yesterday, German drugmaker Altana threw its own hat into the ring, filing for US approval of a nasal spray formulation of its ciclesonide steroid product.