Cipla Gets US FDA Approval for Cancer Generic Drug Paclitaxel

Apr 11, 2025

US FDA approval, Cipla, cancer generics, metastatic breast cancer
US FDA approval, Cipla, cancer generics, metastatic breast cancer

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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.

US FDA approval
Cipla
cancer generics
metastatic breast cancer
US FDA approval
Cipla
cancer generics
metastatic breast cancer

Cipla Gets US FDA Approval for Cancer Generic Drug Paclitaxel

Apr 11, 2025

US FDA approval, Cipla, cancer generics, metastatic breast cancer
US FDA approval, Cipla, cancer generics, metastatic breast cancer

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.

Share:

US FDA approval
Cipla
cancer generics
metastatic breast cancer
US FDA approval
Cipla
cancer generics
metastatic breast cancer