BMS Reaches Settlement with Dr. Reddy's on Revlimid Patent Following USPTO Victory

ProtectionRevlimidBristol-Myers Squibb exhausted all available options in the patent dispute.

On the 17th, foreign media reported that BMS has reached an agreement with IndiaGeneric DrugsDr. Reddy’s Laboratories Reaches Settlement. Reportedly, this deal builds upon another agreement previously reached by Celgene, under which Bristol-Myers Squibb (BMS) permitted the Indian generic drug manufacturer Natco Pharma to engage in limited activities starting from March 2022.SalesGeneric version of Revlimid. Initially, Natco was permitted to sell a “median percentage” of the total monthly sales volume of Revlimid. Over time, this quantity could gradually increase to one-third.

Under the settlement agreement reached with Dr. Reddy’s, Bristol-Myers Squibb (BMS) granted it a market entry window for its generic drug in the United States that follows Natco’s. In another agreement signed last March, BMS also permitted Alvogen to begin marketing its generic version at some point after March 2022; however, until January 31, 2026, the volume of Revlimid generics sold by Alvogen must not exceed an agreed-upon percentage.

Revlimid (lenalidomide) is an immunomodulatory antineoplastic agent developed by Celgene through systematic optimization of thalidomide. It received FDA approval in late 2005 for the treatment of myelodysplastic syndromes. In 2009, just four years after its launch, Revlimid’s annual sales surpassed $1 billion.

Subsequently, with successive expansions of its indications, Revlimid was approved for the treatment of multiple myeloma and mantle cell lymphoma, driving its sales to climb year by year. In 2019, its annual sales surpassed $10 billion for the first time, and in the first half of this year, Revlimid generated $5.8 billion in revenue.

Star products naturally attract numerous competitors. It is reported that although some patents for Revlimid will not expire until 2027, the drug will face generic competition as early as 2022. As more pharmaceutical companies begin developing generic versions of Revlimid, this timeline may be accelerated further.

Last February, when Alvogen launched its generic version of Revlimid in Romania, Croatia, and Bulgaria, BMS investors were caught off guard. BMS executives have been making every effort to soothe uneasy investors, claiming that Alvogen would not be able to achieve widespread distribution in Europe and that the launch would not have a significant impact on Revlimid’s sales.

In 2019, Celgene repeatedly raised the unit price of Revlimid to safeguard its status as a first-line therapy, sparking widespread dissatisfaction. The patent cliff for Revlimid, Celgene’s flagship product, was also the most significant concern among external observers prior to Bristol-Myers Squibb’s $74 billion acquisition of Celgene last year, a move aimed at offsetting the declining performance of its Opdivo franchise.

At that time, some analysts believed that investors were highly concerned about the risks associated with Revlimid. If generic versions of Revlimid had entered the market earlier, Bristol-Myers Squibb’s (BMS) revenue would have taken a $3 billion hit in 2021, escalating to $7.5 billion the following year. However, prior to the acquisition, a ruling by the United States Patent and Trademark Office reassured investors.

Last year, the Patent Trial and Appeal Board (PTAB) ruled that the three patents challenged by Dr. Reddy’s Laboratories regarding Revlimid were invalid, meaning Dr. Reddy’s could not risk launching a generic version of Revlimid before 2023. Geoffrey Porges, an analyst at Leerink, believes this ruling will also accelerate Bristol-Myers Squibb’s acquisition of Celgene.

By reaching a settlement with Dr. Reddy’s Laboratories, Celgene will effectively withdraw from the market in the short term. In recent years, Celgene has predominantly adopted this approach in response to generic competitors. Under these settlement agreements, generic manufacturers will be permitted to sell unlimited quantities of generic Revlimid in the United States starting January 31, 2026.

This article is sourced from EqualOcean. Original article by Lin Yiling. For reprints or collaborations, please click hereReprint Notice, unauthorized reprints will be subject to legal action.