USFDA tentative approval for partner's Olaparib Tablets (about USD 1.4 bn US market)
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Alembic's partner NATCO Pharma received USFDA tentative approval for Olaparib Tablets in 100mg and 150mg strengths, the generic of AstraZeneca's Lynparza. Alembic will handle US distribution while NATCO manufactures. The product targets an estimated USD 1.4 billion US market over 12 months ending March 2026, per IQVIA. Para IV litigation with AstraZeneca is still ongoing, so commercial launch awaits the legal outcome. Alembic now holds 244 cumulative ANDA approvals from USFDA.
Tentative approval alone does not allow immediate launch; commercial entry depends on Para IV litigation outcome. Positive long-term pipeline signal for US generics business.