HQ Team
December 29, 2022:
HQ Team
December 29, 2022: A US court dismissed all claims against Dr. Reddy’s Laboratories Inc., a wholly-owned subsidiary, in an antitrust complaint related to the cancer drug Revlimid.
The company and its subsidiary were named as defendants, along with Celgene, Bristol Myers Squibb and other generic pharmaceutical companies, in a federal and state antitrust law and other state laws, according to a BSE filing.
The November 22 complaint alleged that the defendants improperly restrained competition and maintained a shared monopoly in selling brand and generic Revlimid in the US.
“On December 22, 2022, and December 27, 2022, the plaintiffs voluntarily dismissed Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc., respectively, from the case. All claims against the company in the litigation have now been dismissed,” according to the BSE statement.
Lenalidomide, sold under the trade name Revlimid among others, is a medication used to treat multiple myeloma, smouldering myeloma, and myelodysplastic syndromes.
Multiple myeloma
Oral medication is used after at least one other treatment for multiple myeloma and generally with dexamethasone.
The bone marrow makes different types of immune cells, including plasma cells. In multiple myeloma, plasma cells become cancerous—or myeloma—cells. These cells can go undetected and multiply, crowding healthy cells in the marrow.
Lenalidomide was approved for medical use in the United States in 2005. It is on the World Health Organization’s List of Essential Medicines.
Dr. Reddy’s Labs has a presence in global generics, pharmaceutical services, active ingredients, and proprietary products.
The drugmaker clocked a 12% growth in consolidated net profit to INR 11,128 crore on a 9% rise in revenue to Rs 63,057 crore in the second quarter of FY23 over the same quarter last fiscal.
Rochem International Inc., Johnson Matthey, ASPIRE, Biocon, Changzhou Pharmaceutical Factory, Cipla, and Haoyuan Chemexpress Co., are the major players in the Revlimid market.
Litigation woes
The drug went off-patent this year as patent disputes rose.
Natco Pharma, an Indian company, was the first to unveil a generic version of lenalidomide capsules in the US market.
Natco Pharma was granted a limited license by Celgene, as were Sun Pharma, Cipla, Zydus Lifesciences and Dr Reddy’s Laboratories.
Dr. Reddy’s, in September 2020, announced a settlement of its litigation with Celgene. Celgene agreed to provide the Indian firm with a license to sell volume-limited amounts of generic lenalidomide capsules in the US.
In September 2021, the FDA approved DRL’s abbreviated new drug application for Revlimid.
$2.58 billion market
In December 2020, Cipla settled its patent dispute with Celgene, while Sun Pharma entered a patent settlement with Celgene in June 2021. Cadila reached an agreement with Celgene n March 2021.
The Natco-BMS (Celgene) Revlimid litigation was settled in December 2015, and a settlement allowed Natco to unveil generic Revlimid in March 2022 but with conditions.
The riders were the pact allowed Natco with a mid-single-digit market share constraint in the first year, which can gradually increase to more than 33% in the final year of exclusivity in the fiscal year ending 2026.
Post-January 2026, there would not be any market share constraints. Revlimid had annual sales of $2.58 billion for the 12 months ending June 2022, according to IQVIA data.
The November 22 complaint alleged that the defendants improperly restrained competition and maintained a shared monopoly in selling brand and generic Revlimid in the US.
“On December 22, 2022, and December 27, 2022, the plaintiffs voluntarily dismissed Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc., respectively, from the case. All claims against the company in the litigation have now been dismissed,” according to the BSE statement.
Lenalidomide, sold under the trade name Revlimid among others, is a medication used to treat multiple myeloma, smouldering myeloma, and myelodysplastic syndromes.
Multiple myeloma
Oral medication is used after at least one other treatment for multiple myeloma and generally with dexamethasone.
The bone marrow makes different types of immune cells, including plasma cells. In multiple myeloma, plasma cells become cancerous—or myeloma—cells. These cells can go undetected and multiply, crowding healthy cells in the marrow.
Lenalidomide was approved for medical use in the United States in 2005. It is on the World Health Organization’s List of Essential Medicines.
Dr. Reddy’s Labs has a presence in global generics, pharmaceutical services, active ingredients, and proprietary products.
The drugmaker clocked a 12% growth in consolidated net profit to INR 11,128 crore on a 9% rise in revenue to Rs 63,057 crore in the second quarter of FY23 over the same quarter last fiscal.
Rochem International Inc., Johnson Matthey, ASPIRE, Biocon, Changzhou Pharmaceutical Factory, Cipla, and Haoyuan Chemexpress Co., are the major players in the Revlimid market.
Litigation woes
The drug went off-patent this year as patent disputes rose.
Natco Pharma, an Indian company, was the first to unveil a generic version of lenalidomide capsules in the US market.
Natco Pharma was granted a limited license by Celgene, as were Sun Pharma, Cipla, Zydus Lifesciences and Dr Reddy’s Laboratories.
Dr. Reddy’s, in September 2020, announced a settlement of its litigation with Celgene. Celgene agreed to provide the Indian firm with a license to sell volume-limited amounts of generic lenalidomide capsules in the US.
In September 2021, the FDA approved DRL’s abbreviated new drug application for Revlimid.
$2.58 billion market
In December 2020, Cipla settled its patent dispute with Celgene, while Sun Pharma entered a patent settlement with Celgene in June 2021. Cadila reached an agreement with Celgene n March 2021.
The Natco-BMS (Celgene) Revlimid litigation was settled in December 2015, and a settlement allowed Natco to unveil generic Revlimid in March 2022 but with conditions.
The riders were the pact allowed Natco with a mid-single-digit market share constraint in the first year, which can gradually increase to more than 33% in the final year of exclusivity in the fiscal year ending 2026.
Post-January 2026, there would not be any market share constraints. Revlimid had annual sales of $2.58 billion for the 12 months ending June 2022, according to IQVIA data.
