Might we see generic abiraterone acetate this year?


On Wednesday the U.S. Patent Trial and Appeal Board invalidated the last remaining patent on abiraterone acetate (Zytiga), making it possible that generic forms of abiraterone acetate would be available in 2018 (at least in the US).

We can expect Johnson & Johnson to appeal this decision, so the early availability of generic abiraterone acetate is not guaranteed. What is more, the situation is different outside the US, where patent protection for Zytiga appears to exist until 2022.

For a detailed discussion of this issue, please see this link.

Clearly the availability of generic forms of abiraterone acetate would be a major bonus for patients since one could expect the price of this drug to drop significantly within about 12 months of approval of the first generic formulation of the drug. If the U.S. Patent Trial and Appeal Board’s ruling is upheld, we can expect to see the first generic formulation of abiraterone acetate come available in about October this year.

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