Archive · 19 Jul 2026
NATCO Pharma Gets USFDA Tentative Nod for Olaparib Tablets
Alembic Pharmaceuticals and its partner NATCO Pharma have received a tentative approval from the US Food and Drug Administration (USFDA) for their generic version of Olaparib Tablets.
These tablets are used to treat certain types of cancer and are a generic equivalent of AstraZeneca’s Lynparza.
The approval is a big step, but the actual launch depends on the outcome of a legal dispute.
The US market for these tablets is estimated to be worth $1.4 billion.
This approval adds to Alembic’s growing list of USFDA-approved products, helping them expand in the US market.
However, the company will have to wait for the legal issues to be resolved before they can start selling the product.
Alembic Pharmaceuticals and NATCO Pharma received USFDA tentative approval for generic Olaparib Tablets (100 mg and 150 mg).
The tablets are a generic equivalent of AstraZeneca’s Lynparza, used to treat certain cancers.
The US market size for Olaparib Tablets is estimated at $1.4 billion for the 12 months ended March 2026.
Commercial launch is subject to ongoing Paragraph IV litigation related to the product.
Alembic Pharmaceuticals’ cumulative USFDA ANDA approvals have risen to 244, including 224 final and 20 tentative approvals.
- Who
- Alembic Pharmaceuticals and NATCO Pharma
- What
- Received USFDA tentative approval for generic Olaparib Tablets
- When
- Approval received, commercial launch timeline uncertain due to litigation
- Where
- United States
- Why
- To address a significant market opportunity in the US generic pharmaceutical market
Alembic and NATCO Pharma
AstraZeneca
Market Entry
Alembic and NATCO Pharma
Alembic and NATCO Pharma aim to enter the US market with a generic version of Olaparib, targeting a significant market opportunity.
AstraZeneca
AstraZeneca may oppose the market entry due to ongoing Paragraph IV litigation.
- Company
- Alembic Pharmaceuticals and NATCO Pharma
- Approval
- USFDA tentative approval for Olaparib Tablets (100 mg and 150 mg)
- Reference Drug
- AstraZeneca’s Lynparza
- Market Size
- $1.4 billion (estimated for 12 months ended March 2026)
- Indication
- Treatment of certain cancers
- Alembic’s USFDA ANDA Approvals
- 244 (224 final, 20 tentative)
- Commercial Launch
- Subject to ongoing Paragraph IV litigation