Pharma major Lupin has announced that it has received approval for its Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), from the United States Food and Drug Administration (FDA) to market a generic version of AbbVie, Inc’s (AbbVie) AndroGel 1.62%.

Lupin’s Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), is the generic equivalent of AbbVie’s AndroGel, 1.62%. It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:

• Primary hypogonadism (congenital or acquired) and
• Hypogonadotropic hypogonadism (congenital or acquired)

Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), (RLD: AndroGel) had annual sales of approximately USD 893 million in the US (IQVIA MAT December 2018).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products, and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds the global leadership position in the Anti-TB segment.

Lupin is the 8^th largest generics pharmaceutical company in terms of market capitalization (28^th December 2018, Bloomberg) and the 8th largest generics pharmaceutical company in terms of revenues (30^th September 2018, Bloomberg LTM) globally. The Company is the 3^rd largest pharmaceutical player in the US by prescriptions for the Total Market (IQVIA MAT December 2018); 3^rd largest Indian pharmaceutical company by global revenues (30^th September 2018, Bloomberg LTM); 6^th largest generic pharmaceutical player in Japan (IQVIA MAT December 2018) and 5^th largest company in the Indian Pharmaceutical Market (IQVIA MAT December 2018).

For the financial year ended 31^st March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively.