USFDA Gives Green Light to Lupin's Generic MS Drug - $195M US Market Opens!

Lupin Pharmaceuticals announced on Friday that it has secured tentative approval from the United States Food and Drug Administration (USFDA) to market Siponimod Tablets, a generic medication for treating multiple sclerosis.

Key Development

• The Mumbai-based company received tentative approval for its Abbreviated New Drug Application (ANDA) for Siponimod Tablets in strengths of 0.25 mg, 1 mg, and 2 mg.
• This approval signifies a crucial step for Lupin in expanding its footprint in the highly competitive US pharmaceutical market.

Product Information

• Siponimod Tablets are bioequivalent to Mayzent tablets, originally developed by Novartis Pharmaceuticals Corporation.
• The drug is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. This includes conditions such as clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

Manufacturing and Market Potential

• The new product will be manufactured at Lupin's state-of-the-art facility located in Pithampur, India.
• As per IQVIA data for October 2025, Siponimod tablets had an estimated annual sales of USD 195 million in the US market.
• This substantial market size presents a significant revenue opportunity for Lupin upon commercialization.

Stock Performance

• Following the news, shares of Lupin experienced a slight uptick, trading 0.42 per cent higher at Rs 2,100.80 apiece on the BSE.

Impact

• The USFDA approval is expected to enhance Lupin's revenue streams and profitability, particularly by strengthening its presence in the North American market.
• It validates Lupin's robust research and development capabilities in producing complex generic drugs.
• A successful market launch could lead to increased market share and improved investor confidence in the company's growth prospects.
• Impact Rating: 8

Difficult Terms Explained

• Generic Drug: A pharmaceutical drug that is equivalent to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
• USFDA: The United States Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, etc.
• Abbreviated New Drug Application (ANDA): A type of drug application submitted to the USFDA for approval of a generic drug. It is 'abbreviated' because it relies on the FDA's prior findings of safety and efficacy of the brand-name drug.
• Bioequivalent: Means that the generic drug performs in the same manner and with the same therapeutic equivalence as the brand-name drug.
• Multiple Sclerosis (MS): A chronic, unpredictable disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body.
• Clinically Isolated Syndrome (CIS): The first episode of neurologic symptoms suggestive of multiple sclerosis, lasting at least 24 hours.
• Relapsing Remitting Disease (RRMS): The most common form of MS, characterized by distinct attacks or relapses of new or worsening neurologic symptoms, followed by periods of partial or complete recovery.
• Active Secondary Progressive Disease (SPMS): A stage of MS that typically follows the relapsing-remitting form, where neurologic damage accumulates steadily over time, with or without superimposed relapses and remissions.
• IQVIA: A global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Their data is frequently used to estimate market sales.