Did Lupin Just Get FDA Approval for Its Generic Cancer Drug?
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Synopsis
Lupin has achieved a significant milestone by securing FDA approval for its generic Lenalidomide capsules, offering hope for cancer patients. This breakthrough not only highlights Lupin's commitment to affordable healthcare but also positions it as a key competitor in the oncology market.
Key Takeaways
- Lupin has received FDA approval for Lenalidomide capsules.
- The drug treats multiple myeloma and other conditions.
- Manufacturing will take place in Pithampur, Madhya Pradesh.
- This generic version aims to be a cost-effective alternative to Revlimid.
- Estimated annual sales for the drug in the US are around $7,511 million.
New Delhi, Sep 18 (NationPress) The Indian pharmaceutical company Lupin has revealed that it has received approval from the US Food and Drug Administration for its abbreviated new drug application concerning Lenalidomide capsules in strengths ranging from 2.5 mg to 25 mg, aimed at treating cancer patients.
The approval allows the use of Lenalidomide for adult patients suffering from multiple myeloma—a severe type of blood cancer—when combined with dexamethasone as a maintenance therapy following autologous hematopoietic stem cell transplantation, as stated by the company in an exchange filing.
Additionally, it is also approved for treating transfusion-dependent anemia in patients with low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality.
These Lenalidomide capsules serve as a generic alternative to Revlimid, originally developed by Bristol-Myers Squibb Company.
The manufacturing of this product will take place at Lupin’s facility in Pithampur, Madhya Pradesh, as mentioned in the statement.
Lupin highlighted that this generic version will offer a more affordable option compared to Revlimid.
The Lenalidomide capsules—available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg (reference listed drug Revlimid)—are estimated to have annual sales of approximately $7,511 million in the US.
Headquartered in Mumbai, Lupin is a global pharmaceutical entity operating in over 100 markets, focusing on both branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The company boasts 15 manufacturing sites and seven research centers worldwide, employing more than 24,000 individuals.
Recently, Lupin also secured FDA approval for Minzoya, a generic contraceptive tablet, which is the equivalent of Balcoltra developed by Avion Pharmaceuticals LLC. Like Lenalidomide, Minzoya will also be produced at Lupin's Pithampur facility.
On Thursday, however, Lupin shares experienced a slight decline, closing at Rs 2,030.50, down Rs 0.70, or 0.03 percent, from the previous day’s close.
In the past five trading days, the stock has decreased by Rs 5.30, or 0.26 percent. Over the last month, the shares of this pharmaceutical giant have increased by Rs 62.30, or 3.17 percent.
Point of View
I recognize the importance of Lupin's recent FDA approval for Lenalidomide in the context of providing affordable treatment options for cancer patients. This development underscores the need for continued support for generic drug manufacturing, which can significantly lower healthcare costs while improving accessibility for patients nationwide.
NationPress
20/09/2025
Frequently Asked Questions
What is Lenalidomide used for?
Lenalidomide is primarily used for treating adult patients with multiple myeloma and for managing transfusion-dependent anemia in myelodysplastic syndromes.
Who developed Lenalidomide?
Lenalidomide is a generic version of Revlimid, which was originally developed by Bristol-Myers Squibb Company.
Where will Lupin manufacture Lenalidomide?
Lupin will manufacture Lenalidomide capsules at its facility located in Pithampur, Madhya Pradesh.
What are the strengths available for Lenalidomide capsules?
Lenalidomide capsules will be available in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.
What is the estimated annual sales for Lenalidomide in the US?
The estimated annual sales for Lenalidomide capsules in the US is approximately $7,511 million.
