Johnson & Johnson, Momenta Pharma File Patent Infringement Lawsuit Against Natco, Mylan in US for Glatiramer Acetate Injection.

Summary :

• Johnson & Johnson and Momenta Pharmaceuticals lawsuit alleges infringement of two old patents associated with 20mg/ml and 40mg/ml Glatiramer Acetate injection, Natco said in a regulatory filing.
• Glatiramer Acetate injection is used to treat relapsing forms of multiple sclerosis in adults.

“This lawsuit has been filed in the Pennsylvania Federal Court. Natco and its marketing partner, Mylan believe this is a meritless suit for a product that has been in the market for more than five years. Mylan and Natco will strongly defend against this suit,” the company said.

About Glatiramer Acetate Injection

Description – Glatiramer acetate is a mix of synthetic polypeptides that includes L-glutamic acid, L-alanine, L-tyrosine, and L-lysine at an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. Since glatiramer acetate is a heterogeneous drug, there is limited information about its physicochemical properties. Originally, glatiramer acetate was designed as a stimulant of myelin basic protein (MBP), a myelin antigen involved in the development of multiple sclerosis (MS), to induce experimental autoimmune encephalitis (MS animal model). However, the opposite was observed. Glatiramer acetate exhibits several immunomodulatory effects and reduces the relapse rate of relapsing-remitting multiple sclerosis (RRMS) by 30%

• Indication – Glatiramer acetate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
• Protein Binding– Glatiramer acetate is highly bound to plasma proteins.
• Metabolism – Glatiramer acetate ​​is a mixture of synthetic polypeptides hydrolyzed by proteases.

The J&J drug in question is Momenta’s Glatopa, or glatiramer acetate injection, a generic formulation of Teva Pharmaceutical’s multiple sclerosis med Copaxone. Under a partnership with Sandoz, the Momenta med won an approval as the first copycat to Teva’s blockbuster MS med back in April 2015.

About Johnson & Johnson

Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.

About Nacto Pharma

Natco Pharma is an Indian multinational pharmaceutical company based in Hyderabad. The company manufactures finished dosage formulations active pharmaceutical ingredients and crop health science products, and also provides contract manufacturing services.

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