Lupin receives tentative FDA approval for generic AndroGel®, 1.62%
Mumbai, Baltimore, 17 April, 2018: Pharma major Lupin announced that it has received tentative approval for its Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) from the United States Food and Drug Administration (FDA) to market a generic version of AbbVie Inc.’s AndroGel®, 1.62%.
Lupin’s Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) is the generic equivalent of AbbVie Inc.’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 gm actuation) had annual sales of approximate USD 956.9 million in the US (IQVIA MAT January 2018).
Lupin is the 11th and 7th largest generics pharmaceutical company by market capitalization (December 31st, 2017, Bloomberg) and revenues (September 30th, 2017, Bloomberg LTM) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT December 2017); 2nd largest Indian pharmaceutical company by global revenues (September 30th, 2017, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan and 5th largest company in Indian Pharmaceutical Market (IQVIA MAT December 2017).
For the financial year ended 31st March, 2017, Lupin’s Consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries please contact –
VP – Corporate Communications
Ph: +91-22-66402531 / 8291013225
Head – Investor Relations
AndroGel® is a registered trademark of Unimed Pharmaceuticals, LLC