Cipla has received final approval from the US Food and Drug Administration (US FDA) for its Protein-bound Paclitaxel, a generic version of the cancer drug Abraxane. The product is expected to be launched in the first half of FY 2025-26, strengthening Cipla’s oncology portfolio in the US market.

Key Highlights

US FDA Final Approval Received

• Cipla’s ANDA for Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial, has been approved by the USFDA.

• Approval was granted on April 10, 2025.

Generic of Blockbuster Cancer Drug Abraxane

• The drug is a therapeutic equivalent to Bristol Myers Squibb’s Abraxane, used to treat metastatic breast cancer, non-small cell lung cancer (NSCLC) and metastatic pancreatic cancer.

• It is classified as an AB-rated generic.

Commercial Launch by September 2025

• The injectable formulation is expected to be launched by September 2025 in the US.

• Abraxane reported global sales of $875 million in 2024, though revenues have declined post-patent expiry.

With the FDA approval for its generic version of Abraxane, Cipla is set to expand its oncology footprint in the US market. The launch of Protein-bound Paclitaxel will offer a more affordable treatment option for cancer patients while reinforcing Cipla’s commitment to increasing access to life-saving therapies.