Alembic Pharma partner NATCO gets USFDA tentative nod for generic Olaparib tablets; US market size at USD 1.4 bn
New Delhi, July 19
Alembic Pharmaceuticals said its partner NATCO Pharma has received tentative approval from the United States Food and Drug Administration for its abbreviated new drug application for Olaparib Tablets in 100 mg and 150 mg strengths, a generic equivalent of AstraZeneca's Lynparza tablets.
The approval is for the indication covered under the approved labelling of the reference listed drug. Alembic Pharmaceuticals will distribute the product in the United States, while NATCO Pharma will manufacture the tablets.
The product is expected to address a significant market opportunity in the US. Olaparib Tablets in the 100 mg and 150 mg strengths had an estimated market size of around USD 1.4 billion for the 12 months ended March 2026, according to IQVIA data cited by the company.
However, the commercial launch timeline remains subject to the ongoing Paragraph IV litigation related to the product. The tentative approval therefore marks a regulatory milestone, while the outcome of the litigation will remain an important factor for the product's market entry.
Olaparib is a PARP inhibitor used in the treatment of certain cancers and is marketed as Lynparza by AstraZeneca. The approval strengthens Alembic's product pipeline in the US generic pharmaceutical market and expands its portfolio of products targeting large-market opportunities.
Alembic Pharmaceuticals' cumulative tally of USFDA ANDA approvals has risen to 244, comprising 224 final approvals and 20 tentative approvals.
Alembic Pharmaceuticals is a vertically integrated research and development-focused pharmaceutical company with operations spanning generic medicines and branded generics. The company manufactures and markets generic pharmaceutical products globally and operates research and manufacturing facilities approved by regulatory authorities in developed markets, including the USFDA.
The latest approval comes as Indian pharmaceutical companies continue to expand their presence in the US generic market through partnerships, complex products and large-market opportunities. For Alembic, the approval provides another potential growth avenue, although the ongoing litigation and the eventual commercial launch remain key monitorables.
— ANI
Reader Comments
Finally, a step towards affordable cancer treatment! But I hope the litigation doesn't drag on forever. These cases can take years, and patients need cheaper alternatives now. 🙏
Tentative approval is good, but the real test is the Paragraph IV litigation. Big pharma doesn't let go of patents easily. Hope NATCO and Alembic have a strong legal team. These generics are crucial for bringing down costs globally.
As someone who's seen family struggle with cancer, this approval gives hope. Olaparib is a lifesaver for many. Great job by Indian pharma companies in making these drugs more accessible. Kudos to Alembic and NATCO! 👏
While this is positive, I wish Indian companies would focus more on making these drugs affordable in India too. Many cancer patients here still can't afford treatment. The US market is lucrative, but what about our own people? 🤔
Impressive how Alembic now has 244 ANDA approvals. Indian pharma is a powerhouse in generics! The USFDA trust in these companies speaks volumes about quality and compliance. This partnership with NATCO looks solid. 👍
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