LUPIN LIMITED

Catalyst Pharmaceuticals settled patent litigation with Teva, preventing Teva from marketing a generic Firdapse before February 25, 2035. The settlement ends ongoing litigation in U.S. courts. Firdapse, for Lambert-Eaton myasthenic syndrome, saw a 19.7% revenue increase to $79.3 million in Q3 2024, with full-year revenue expected at $300-$310 million.

Catalyst Pharmaceuticals settled patent litigation with Teva, preventing Teva from marketing a generic Firdapse before February 25, 2035, unless specific conditions occur. The settlement ends ongoing litigation in the U.S. District Court for New Jersey. Firdapse, for Lambert-Eaton myasthenic syndrome, saw a 19.7% revenue increase to $79.3 million in Q3 2024.

Lupin Ltd. received tentative FDA approval for its generic Ivacaftor oral granules, equivalent to Vertex's 'Kalydeco', in 25 mg, 50 mg, and 75 mg strengths for cystic fibrosis treatment. Eligible for 180-day exclusivity, it's manufactured in Nagpur, targeting patients with specific CFTR gene mutations.

Lupin Limited received tentative FDA approval for Ivacaftor Oral Granules, generic equivalent to Kalydeco®, for cystic fibrosis treatment. Eligible for 180 days exclusivity, it's manufactured in Nagpur, India. Lupin, a global pharma leader, focuses on improving patient health outcomes.

Lupin Limited received tentative FDA approval for its generic Loteprednol Etabonate Ophthalmic Gel, 0.38%, equivalent to Lotemax® SM, potentially granting 180-day exclusivity. The gel treats post-operative eye inflammation and pain, with U.S. sales estimated at $36 million annually. Manufactured in India, Lupin is a global pharmaceutical leader.

Lupin Limited received tentative FDA approval for its generic version of Lotemax SM ophthalmic gel, 0.38%, used for post-operative eye inflammation and pain. As the first-to-file, Lupin may enjoy 180-day exclusivity. The product, with USD 36 million annual US sales, will be produced in India.

Catalyst Pharmaceuticals and SERB S.A. settled patent litigation with Teva, preventing Teva from marketing a generic version of FIRDAPSE® before February 25, 2035, unless specific conditions occur. Litigation continues against Hetero and Lupin. The agreement will be reviewed by U.S. regulatory bodies.

Catalyst Pharmaceuticals and SERB S.A. settled patent litigation with Teva, preventing Teva from marketing a generic version of FIRDAPSE® before February 25, 2035, unless specific conditions occur. Ongoing litigation against Hetero and Lupin continues. The agreement will be reviewed by U.S. regulatory bodies.

The Trichomoniasis market is expected to grow significantly by 2032, driven by increased disease prevalence and new drug launches. Key players include Sekisui Diagnostics, Becton Dickinson, and Pfizer. Treatments like Secnidazole and Metronidazole are effective. The report covers market trends, epidemiology, and therapeutic advancements, emphasizing unmet needs and future opportunities.

The CMO market in the pharmaceutical industry is growing, driven by cost-efficient resources in emerging markets, FDA-regulated drug product demand, and complex drug discovery processes. CMOs ensure regulatory compliance, quality management, and ethical standards, supporting biopharmaceutical startups. The API manufacturing segment and APAC region are key growth areas, despite challenges like limited capabilities in emerging countries.