Alembic Pharmaceuticals Limited (“Alembic”) today announced that its partner NATCO Pharma Limited (“NATCO”) has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olaparib Tablets, 100 mg and 150 mg. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD), Lynparza® Tablets, 100 mg and 150 mg, of AstraZeneca Pharmaceuticals LP, for the indications specified in the approved labeling.
Under the partnership arrangement, NATCO will manufacture Olaparib Tablets, while Alembic will be responsible for commercialization and distribution of the product in the United States market. The Para IV litigation related to the product remains ongoing.
According to IQVIA data, Olaparib Tablets, 100 mg and 150 mg, recorded an estimated U.S. market size of approximately USD 1.4 billion for the twelve months ending March 2026, highlighting the commercial significance of this approval opportunity. With this development, Alembic continues to strengthen its presence in the U.S. generics market. The Company has received a cumulative total of 244 ANDA approvals from the USFDA, comprising 224 final approvals and 20 tentative approvals.
Alembic Pharmaceuticals Limited is a vertically integrated research-driven pharmaceutical company with a legacy of healthcare innovation dating back to 1907. Headquartered in India, the Company is a publicly listed global pharmaceutical organization engaged in the development, manufacturing and marketing of generic pharmaceutical products worldwide.
Alembic operates advanced research and manufacturing facilities that are approved by regulatory authorities across several developed markets, including the United States Food and Drug Administration. The Company is also among the leading players in India’s branded generics segment, with a portfolio of well-established brands supported by a field force of more than 5,500 professionals serving doctors and patients across the country.
