US FDA approves Zydus menopause patch with 180-day exclusivity
ZYDUSLIFE · price
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The US Food and Drug Administration approved Zydus's Estradiol and Levonorgestrel patch for moderate to severe menopause symptoms and osteoporosis prevention. The generic version of Climara Pro is eligible for 180 days of US market exclusivity, subject to applicable rules, beginning at first commercial marketing. The reference product had annual US sales of about USD 45.7 million. Zydus will make it at its Moraiya plant.
The approval may strengthen Zydus's US generic portfolio and create sales opportunities, but revenue will depend on its US launch, exclusivity and competition.