Endo’s Par has introduced the first generic version of Mallinckrodt’s chronic idiopathic constipation medicine Amitiza, realizing the terms of a settlement agreement announced more than six years ago.
Endo’sPar Pharmaceutical unit has introduced the first generic version of Mallinckrodt’s Amitiza (lubiprostone) 8mcg and 24mcg soft gel capsules in the US, an authorized generic, years ahead of several potential abbreviated new drug application rivals.
More than six years ago, before Endo acquired Par and Mallinckrodt acquired Amitiza developer Sucampo, Par and its Anchen Pharmaceuticals...
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.
Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.
The UPC Court of Appeal has signaled that in pharma disputes, being ready to launch can be as risky as actually launching. In a major setback for Zentiva, the court ruled that completing certain steps well before patent expiry amounted to “setting the stage” for infringement.
Shortly after filing its lead candidate for ADHD through the FDA’s 505(b)(2) hybrid new drug application pathway, Cingulate has appointed interim leadership after placing chairman and CEO Shane Schaffer on administrative leave over legal matters unrelated to the company.
Roche and its Genentech subsidiary have sued Shanghai Henlius Biotech and commercialization partner Organon in the US, alleging infringement of 24 patents covering Perjeta (pertuzumab). The litigation follows Roche’s recent disclosure that biosimilars to Perjeta could launch as soon as 2026.
Boasting the “lowest WAC price among branded biosimilars to Stelara”, Accord BioPharma has launched its Imuldosa version of ustekinumab in the US at a 92% discount to the blockbuster immunology brand.
