Lupin gets tentative USFDA approval for billion-dollar testosterone drug

India-based pharma major Lupin said the US drugs regulator has granted it a conditional, or tentative, approval to sell a generic version of the popular testosterone gel AndroGel.

AndroGel, made by AbbVie Inc, is a big-selling drug with annual sales of well over $1 bln.

AbbVie, which has patents valid up to 2020 on the product, has been fighting to keep generic competitors at bay, and is engaged in legal cases to protect its product.

A tentative approval allows the manufacturer to launch its product as soon as patent protection expires.

AndroGel is available in the 1% and 1.62% concentration, out of which the 1% variant is likely to see generic competition faster.

The approval for Lupin is for the 1.62% concentration, which has annual sales of approximate USD 956.9 million in the US, according to IQVIA.

Testosterone supplements are supposed to help older men withstand some of the effects of low testosterone, such a reduced sex drive and an overall feeling of lethargy.

It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, Lupin said.

Lupin is a multinational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.