HOME > MEDIA > PRESS RELEASES

Lupin receives tentative FDA approval for generic Nudovra (Estradiol Valerate Tablets, 3 mg and 1 mg and Estradiol Valerate and Dienogest Tablets, 2 mg/2 mg and 2 mg/3 mg) Tablets

 

Mumbai, Baltimore, August 22, 2018: Pharma major Lupin announced that it has received tentative approval for its Nudovra (Estradiol Valerate Tablets, 3 mg and 1 mg and Estradiol Valerate and Dienogest Tablets, 2 mg/2 mg and 2 mg/3 mg) Tablets from the United States Food and Drug Administration (FDA) to market a generic version of Bayer HealthCare Pharmaceuticals Inc.’s Natazia® Tablets.

Lupin's Nudovra (Estradiol Valerate Tablets, 3 mg and 1 mg and Estradiol Valerate and Dienogest Tablets, 2 mg/2 mg and 2 mg/3 mg) Tablets is the generic version of Bayer HealthCare Pharmaceuticals Inc.’s Natazia® Tablets. It is an estrogen/progestin combined oral contraceptive (COC), indicated for use by women to prevent pregnancy.

Clobetasol Propionate Cream USP 0.05% had annual sales of approximately USD 108.6 million in the US (IQVIA MAT June 2018).

Nudovra (Estradiol Valerate Tablets, 3 mg and 1 mg and Estradiol Valerate and Dienogest Tablets, 2 mg/2 mg and 2 mg/3 mg) Tablets had annual sales of approximately USD 31.4 million in the US (IQVIA MAT June 2018).

About Lupin Limited

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 global leadership position in the Anti-TB segment.

Lupin is the 8th largest generics pharmaceutical company both in terms of market capitalization (30th June 2018, Bloomberg) and revenues (31st March 2018, Bloomberg LTM) globally. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT June 2018); 3rd largest Indian pharmaceutical company by global revenues (31st March 2018, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT June 2018).

For the financial year ended 31st 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. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinglobal

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 -

Pooja Thakran
VP – Corporate Communications
Email: poojathakran@lupin.com
Ph: +91-22-66402531 / 8291013225

Neha Rao
Head - External Communications
Email: neharao@lupin.com
Ph: +91-22-66402409 /9819073603

Arvind Bothra
Head – Investor Relations
Email: arvindbothra@lupin.com
Ph: +91-22-66402137

*Safe Harbor Statement

Natazia® is a registered trademark of Bayer Intellectual Property GMBH.