Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) Q1 2024 Earnings Call Transcript

But we’re we already have our equipment in place right now to manufacture the product, so I think we’re pretty confident in our ability to get a reasonable market share there as well. Then turning to your last question about letter from the FTC. Yes, we did receive that. We are one of many companies that received the second round of letters from the FTC about Orange Book-listed patents. So we’ve done 2 things since receiving it. One, we’ve had some discussions with the Lilly attorneys who were the ones that submitted it to the Orange Book. And they were confident that it was appropriate from what they did and that they were following the law when they did that. And the second thing we’re doing is that we’re engaging an outside counsel to also look at that.

So we’ll get into that. And my understanding of the time line that you mentioned in the 30 days is we have 30 days once the FDA sends us a letter and we have not gotten that letter as of today. So once we get that letter, we’ll have 30 days to respond from that time. And if our outside counsel is unable to analyze it at that time, then we’ll do so. But I’d also like to add that there’s — we have 3 Orange Book patents, for this product. There’s one that expires in 2036 which is a formulation patent. The patent in question expires in 2038. But then we also have another patent that expires in 2039. So this isn’t the last patent and it’s not the most important patent either. So no matter what happens to this, I don’t think it really changes our trajectory or our implication or our forecast for this product.

Operator: There are no further questions at this time. I’d like to hand the floor back over to management for any closing comments.

Dan Dischner: I want to extend a heartfelt appreciation to everyone who joined us today for Amphastar’s Q1 earnings call and for your continued support. We look forward to sharing our progress with you in the quarters ahead. Have a great day.

Operator: This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.