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What is the duration of kadcyla's market exclusivity rights?

See the DrugPatentWatch profile for kadcyla

In the United States, Kadcyla (trastuzumab emtansine) as a biologic gets 12 years of regulatory data exclusivity under the Biologics Price Competition and Innovation Act. That generally blocks FDA approval of a biosimilar for Kadcyla until 12 years after the initial approval date (Kadcyla was approved on Feb 26, 2013), so exclusivity runs through Feb 26, 2025.

Notes:
- This is separate from, and can be extended by, patent protection around Kadcyla (which may last longer or shorter depending on specific patents).
- Regulatory exclusivity durations vary by country, so check the local regulator (and the product’s patent list) for other jurisdictions.

If you want, I can pull the specific patent expiry dates or the jurisdiction you’re interested in.



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