Lupin receives FDA approval for generic Kapvay® Extended-Release Tablets


Mumbai, October 26, 2017: Pharma Major Lupin announced that it has received final approval for its Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg from the United States Food and Drug Administration (FDA) to market a generic version of Concordia Pharmaceuticals Inc.’s Kapvay® Extended-Release Tablets 0.1 mg.

Lupin’s Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg is the AB rated generic equivalent of Concordia Pharmaceuticals Inc.’s Kapvay® Extended-Release Tablets 0.1 mg. It is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg had annual sales of approximately USD 66 million in the US. (IMS MAT Jun 2017).

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 7th and 6th largest generics pharmaceutical company by market capitalization (June 30th, 2017, Bloomberg) and revenues (March 31st, 2017, Bloomberg) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (Quintiles IMS MAT March 2017); 2nd largest Indian pharmaceutical company by global revenues (March 31st, 2017, Bloomberg); 6th largest generic pharmaceutical player in Japan and 6th largest company in Indian Pharmaceutical Market (Quintiles IMS MAT June 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 –

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

Arvind BothraHead –
Investor Relations and M&A
Email: arvindbothra@lupin.com
Ph: +91-22-66402137

*Safe Harbor Statement

Kapvay® is a registered trademark of Concordia Pharmaceuticals Inc.