Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated May 15, 2025, titled "Alembic Pharmaceuticals receives USFDA Final Approval for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg".
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Alembic Pharmaceuticals has received final approval from the USFDA for its generic version of Rivaroxaban Tablets in four strengths. Rivaroxaban is the generic equivalent of Janssen's popular blood-thinner brand Xarelto, used to reduce the risk of major cardiovascular events. According to IQVIA, the 2.5 mg strength addresses a US$ 445 million market (12 months ending March 2025), and Alembic plans to launch this strength in Q1FY26. The other three strengths (10 mg, 15 mg, 20 mg) together target a much larger US$ 8,052 million market. With this approval, Alembic's cumulative USFDA tally rises to 222 ANDA approvals (198 final and 24 tentative).
This is a positive development for shareholders, as it strengthens Alembic's US generics portfolio and opens access to a large, high-value anticoagulant market. Launch of the 2.5 mg strength in Q1FY26 could provide an early revenue boost, while the remaining strengths represent a significant long-term growth opportunity, though actual revenue share will depend on competition and launch timing.