There's a convoluted process that they can game to extend their exclusivity with the FDA see e.g., https://time.com/6336840/patent-manipulation-insulin-prices/

There's a convoluted process that they can game to extend their exclusivity with the FDA see e.g., https://time.com/6336840/patent-manipulation-insulin-prices/ https://time.com/6336840/patent-manipulation-insulin-prices/