California, USA-based Koios Pharmaceuticals announced that it has filed a challenge to the validity of US Patent 8,644,231, the sole Orange-Book listed patent protecting Rasuvo - a methotrexate autoinjector product marketed by the US subsidiary of privately-held German firm medac GmbH - from generic competition.
Koios further announced that it has entered into a confidential development and commercialization partnership with a leading developer of sterile injectable pharmaceutical products to introduce a generic equivalent to Rasuvo.
Rasuvo is approved in the USA for the treatment of inflammatory autoimmune diseases including rheumatoid arthritis in adults and polyarticular juvenile idiopathic arthritis in children.
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