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Celgene settles Revlimid patent dispute

pharmafile | December 23, 2015 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Celgene, India, Natco, Revlimid, lenalidomide, patents 

Celgene has settled its litigation with Natco Pharma, over the patents for Revlimid, opening the door to increased generic competition for the blockbuster drug years early.

The blood cancer treatment is expected to make Celgene around $5.7 billion in sales in 2015, and currently makes more than 60% of the US-based company’s total revenues.

Celgene will permit India’s Natco, and its US partner Arrow, which is owned by Allergan subsidiary Watson Laboratories, to sell generic Revlimid (lenalidomide) before the April 2027 expiration of Celgene’s last-to-expire patent, with limited volumes allowed on the US market from March 2022.

The volumes permitted will increase incrementally each year, from 10% of all capsules dispensed in the US in 2022, to around one third of capsules in March 2025. In January 31, 2026, Natco will be granted a license to sell unlimited quantities of the drug in the US, more than a year before all the patents officially expire in April 2027.

Natco’s ability to market Revlimid in the US will be contingent on its obtaining approval of an Abbreviated New Drug Application from the FDA.

“We believe strongly in our patent estate for Revlimid, and that this settlement appropriately recognises the strength of our patents. This settlement provides clarity around the future of Revlimid, and we will continue to focus on developing our many important pipeline assets, which provide great potential promise to patients with unmet medical needs,” says Bob Hugin, chairman and chief executive of Celgene. “We remain confident in the strength of our patents, and will continue to vigorously defend them.”

Though it would at first glance appear a bad deal for Celgene, experts say the clarity on its top drug’s future would be a positive in the long-run.

A Jefferies analyst notes: “Though this represents a compromise, overall we view the settlement as a positive, removing a major overhang on shares and enabling a clearer road toward lower-risk long-term growth.”

Joel Levy

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