Lupin Gets USFDA Tentative Nod for Siponimod Tablets for Multiple Sclerosis

Lupin has announced that it has received tentative approval from the USFDA for its generic version of Siponimod Tablets in 0.25 mg, 1 mg and 2 mg strengths. The tablets will be manufactured at the company’s facility in Pithampur, India.

Generic Version of Novartis’ Mayzent

Lupin’s product is bioequivalent to Mayzent, a drug developed by Novartis Pharmaceuticals. Siponimod is used to treat different forms of relapsing multiple sclerosis (MS) in adults, including:

• Clinically isolated syndrome
• Relapsing-remitting MS
• Active secondary progressive MS

The drug helps manage symptoms and slow disease progression.

Market Potential in the US

Siponimod Tablets (reference drug: Mayzent) recorded annual US sales of around USD 195 million, according to IQVIA data for October 2025. Lupin’s approval positions it well to enter this significant market once it receives final clearance.

About Lupin

Lupin Limited is a leading Indian multinational pharmaceutical company headquartered in Mumbai. It specialises in manufacturing generic medicines across several therapeutic areas, including:

• Paediatrics
• Cardiovascular
• Anti-infectives
• Diabetes
• Asthma
• Anti-tuberculosis treatments

Also Read, Best Long-Term Stocks in Dec 2025!

Lupin Share Price Movement

Lupin share price (NSE: LUPIN) was ₹2,100.30, up ₹8.30 (0.40%) as of 12:21 PM on December 5, 2025. The stock opened at ₹2,095 and moved between a high of ₹2,102.20 and a low of ₹2,083.10 during the day. The company’s market capitalisation stands at ₹95,920 crore. Lupin currently trades at a P/E ratio of 33.79 and offers a dividend yield of 0.57%. Over the past year, the stock has touched a 52-week high of ₹2,402.90 and a 52-week low of ₹1,795.20.

Conclusion

The USFDA’s tentative approval for Siponimod Tablets is another positive step for Lupin’s US business. Once fully approved, the company is expected to benefit from strong demand in the US multiple sclerosis market while expanding its global generic drug portfolio.

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