Upsher-Smith Introduces Isotretinoin Capsules in US

AB2-rated to the branded product Absorica®, capsules are available in 10mg, 20mg, 30mg, and 40mg strengths.

Isotretinoin capsules AB2-rated to the branded product Absorica® (isotretinoin) are now available in 10mg, 20mg, 30mg, and 40mg strengths from Upsher-Smith Laboratories. The launch is the result of  a multi-year, multi-product collaboration between Upsher-Smith and New Zealand-based, Douglas Pharmaceuticals, a leading global producer of isotretinoin.

Upsher-Smith will distribute the four strengths of Isotretinoin Capsules under its own label and has also entered into a Private Label Supply and Distribution Agreement with Mayne Pharma. Based on the agreement, Mayne Pharma will serve as Upsher-Smith's private label distribution partner in the US for Isotretinoin Capsules manufactured under the Upsher-Smith abbreviated new drug application. 

"The launch of Isotretinoin Capsules marks an important milestone as we continue to grow and diversify our product portfolio," says Rusty Field, President and CEO, Upsher-Smith. "This product is among others that we've developed through our collaboration with Douglas. In addition, our supply and distribution agreement with Mayne Pharma has the potential to significantly impact this market given the company's established network of healthcare professionals and vast experience in this market." 

The isotretinoin capsule market had US sales of approximately $157 million for the 12 months ending July 2021 according to IQVIA.