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Zydus Cadila receives approval from USFDA to market Ibrutinib Capsules

08 Apr 2021 Evaluate

Zydus Cadila has received final approval from the USFDA to market Ibrutinib Capsules, 70 mg and 140 mg (US RLD: Imbruvica Capsules). Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.

According to the USFDA letter, Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg. Therefore, with this approval, Zydus is eligible for 180 days of generic drug exclusivity for Ibrutinib Capsules, 70 mg. For Ibrutinib Capsules, 140 mg, the company will have 180-days of shared generic drug exclusivity. The 70 mg capsule has brand sales of $32.5 mn, while the 140 mg dose has brand sales of $745.9 mn. Zydus is the first company to receive approval for generic Ibrutinib 70 mg capsules.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

Zydus Lifesciences Share Price

1150.50 -9.35 (-0.81%)
10-Jul-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma. Inds. 1935.25
Dr. Reddys Labs. 1245.50
Cipla 1438.75
Zydus Lifesciences 1150.50
Lupin 2496.05
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