New Drug Option
Lupin Receives Tentative FDA Approval for Enzalutamide Tablets, Offering Alternative Dosing
Lupin Limited has received tentative approval from the U.S. Food and Drug Administration for a generic version of Xtandi, one of the most widely used prostate cancer drugs in the world. The approval covers four dosage strengths — 40 mg, 80 mg, 120 mg, and 160 mg — and positions the Mumbai-based drugmaker to enter a U.S. market worth roughly $3.5 billion a year, according to Financial Post.
The approval is tentative, meaning Lupin cannot sell the drug yet. Commercial launch will only happen once Astellas Pharma's existing patents on Xtandi expire, likely in late 2026 or 2027.
What Tentative Approval Actually Means for Lupin
The FDA grants tentative approval when a generic drug meets all safety, quality, and bioequivalence standards — but a patent or exclusivity period blocks it from going on sale. Vancouver Sun reports that Lupin's tablets were confirmed bioequivalent to Xtandi, the reference listed drug made by Astellas. In plain terms, the generic works the same way as the brand-name version.
Lupin filed what is called an Abbreviated New Drug Application, or ANDA. It included Paragraph IV certifications — legal challenges arguing that Astellas patents are either invalid or not infringed by the generic product. Key Astellas patents, such as U.S. Patent No. 8,183,274, run through late 2026, while others extend to August 2027.
Lupin Adds Two Dosage Strengths Xtandi Does Not Offer
One notable detail: Xtandi is only sold in 40 mg and 80 mg tablets. Lupin's generic will also come in 120 mg and 160 mg strengths. Lupin said these options will give doctors and patients more flexible dosing. Urology specialists have noted that higher-strength tablets could simplify treatment for patients who need larger daily doses, improving how consistently they take their medication.
Lupin distributes its products in over 100 markets worldwide. The company has been building its oncology portfolio as part of a broader shift toward complex generics — a higher-barrier market that typically offers better profit margins than standard generic drugs.
Sandoz Already Approved, Generic Price War Looms
Lupin is not the only company chasing Xtandi's patent cliff. Competitor Sandoz received full FDA approval for its own generic enzalutamide on April 20, 2026, according to research from Calgary Herald. That made Sandoz the first generic version on the U.S. market. When Lupin's final approval comes through, the two companies are expected to compete head-to-head.
Generic entry into a major drug market typically drives prices down 40% to 80% within two years. For prostate cancer patients — especially those on Medicare or without strong insurance — that kind of price drop could make a meaningful difference in out-of-pocket costs. Xtandi's global sales hit roughly $6 billion in fiscal year 2025.
Astellas Braces for Billions in Lost Xtandi Revenue
For Astellas, the clock is ticking. The Japanese drugmaker co-markets Xtandi in the U.S. with Pfizer. As generic competition approaches, Astellas is shifting focus to newer drugs. Its strategy now centers on products like PADCEV for bladder cancer and IZERVAY for an eye condition called geographic atrophy, both expected to hit peak sales in the mid-2030s.
Lupin's shares did not rally on the news. Its stock on the National Stock Exchange ended 1.02% lower at ₹2,343.50 on the day of the announcement, according to Montreal Gazette. Analysts pointed to weak global market signals and the fact that any real revenue from this approval remains months or years away.
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