Patents

Will Novartis’ monopoly on Entresto, one of the biggest-selling small molecule drugs in the US, last until its proffered mid-2025 date? An unfavorable decision by the US Court of Appeals for the Federal Circuit that has handed victory to ANDA sponsor MSN Labs could upend the originator’s projection.

The new court ruling could enhance the appeal of the Unified Patent Court for enforcing European patents.

The wait for US competition to AbbVie’s Lumigan 0.01% glaucoma brand, launched more than a decade ago, goes on, after Mankind bowed to infringement of a key US patent.

A watershed moment is on the horizon for US biosimilars, with Amgen looking poised to debut competition to Eylea (aflibercept).

With sales projected to peak at nearly $700m a year, Galafold – the first oral monotherapy for people living with the ultra-rare genetic disorder Fabry disease – is a lucrative target for ANDA sponsors. However, Teva, which has just put pen to paper on a patent-litigation settlement agreement, will have to wait more than a decade to roll out its generic product.

MSN Laboratories returned to court to attack more US patents shielding Exelixis’ blockbuster oncology drug Cabometyx. However, as with the first ruling, the Indian firm was met with further disappointment.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second

Otsuka Pharma’s acquisition of Jnana seems like a win for its pipeline, but the Japanese major faced a setback in a Delaware District Court where the judge’s opinion put challenger Lupin closer to a generic to its Jynarque (tolvaptan)

Johnson & Johnson’s actions to promote generic competition and lower the price for its crucial tuberculosis treatment, Sirturo (bedaquiline), have satisfied an investigation launched by South Africa’s Competition Commission.