Celgene settles US patent litigation over generic Revlimid

Celgene announced a settlement allowing Natco Pharma's partner, Allergan's Arrow International unit, to market a generic version of Revlimid (lenalidomide) in the US starting on January 31, 2026. Celgene noted that as part of the deal, it will provide Natco with a licence to patents required to manufacture and sell an unlimited quantity of generic Revlimid before the April 2027 expiration of the product's last-to-expire patent.

In addition, Celgene indicated that Natco will receive a "volume-limited" licence to sell generic Revlimid in the US commencing in March 2022. According to Celgene, the volume limit is expected to be a mid-single-digit percentage of the total Revlimid capsules dispensed in the US during the first full year of entry. The US company added that the volume limitation will increase gradually each year until March 2025, while it is not expected to exceed one-third of the total Revlimid capsules dispensed in the US in the final year of the agreement.

"This settlement provides clarity around the future of Revlimid," remarked Celgene CEO Bob Hugin, adding "we remain confident in the strength of our patents, and will continue to vigorously defend them."

Commenting on the news, Jefferies analysts said "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." Revlimid accounted for around 63 percent of Celgene's third-quarter sales of $2.3 billion. The company predicts that the product will generate total revenue of $5.8 billion this year.

For related analysis, read ViewPoints: Natco settlement terms show strength of Celgene's IP position for Revlimid.

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