Celgene settles Revlimid patent litigation with Natco Pharma

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Celgene settles Revlimid patent litigation with Natco Pharma

Generics/News | Posted 05/02/2016 0 Post your comment

Celgene Corporation (Celgene) is to provide India-based Natco Pharma and its US partner, Arrow International – a unit of Allergan – the license to manufacture and market generic Revlimid (lenalidomide) in the US from 31 January 2026, following expiration of patents in the US in April 2017. This will expedite generics competition for the drug, which currently makes up 60% of Celgene’s annual revenue.

Lenalidomide is used to treat people with myeloma (a type of cancer that affects the plasma cells inside bone marrow) and myelodysplastic syndromes (MDS; a group of conditions that affect the bone marrow). The drug is also undergoing clinical trials as a treatment for Hodgkin's lymphoma, as well as non-Hodgkin's lymphoma, chronic lymphocytic leukaemia and solid tumour cancers such as carcinoma of the pancreas.

Revlimid had sales of almost US$5 billion in 2014, making this a lucrative licence for Natco Pharma. However, the license to sell the blood cancer treatment in the US will be volume-limited and will only start in March 2022. Incremental volume increases will be permitted annually from 10% of all capsules dispensed in the US in 2022, to around one-third of capsules in March 2025. A full license will be granted to sell unlimited quantities more than a year before the patents officially expire in April 2027.

Natco Pharma’s ability to market Revlimid in the US will be contingent on its obtaining approval for an abbreviated new drug application (ANDA) from the US Food and Drug Administration (FDA).

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Source: Celgene