Ranbaxy Receives USFDA Approval To Market 80mg Simvastatin Tablets With 180-Day Exclusivity
July 13, 2018
Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Simvastatin Tablets USP, 80mg with 180-day exclusivity in the U.S. The FDA's Office of Generic Drugs has determined Ranbaxy's 80mg Simvastatin Tablets USP, to be bioequivalent, therefore, therapeutically equivalent to the listed drug ZocorŪ Tablets, 80mg, of Merck Research Laboratories. Total annualized market sales for Simvastatin were $ 4.6 billion, out of which the 80mg strength accounted for $ 513 million (IMS - MAT: March 2006).
Simvastatin tablets are indicated in the treatment of patients with Coronary Heart Disease (CHD) or at high risk of CHD, reductions in risk of CHD mortality and cardiovascular events, patients with hypercholesterolemia requiring modifications of lipid profiles and adolescent patients with Heterozygous Familial Hypercholesterolemia (HeFH). A Simvastatin regimen can be started simultaneously with diet.
"This marks a significant day in the history of Ranbaxy. We are offering a generic alternative on an exclusive basis for the second largest pharmaceutical product sold in the U.S. market. Being a fully integrated, research-based pharmaceutical company has allowed us to effectively develop this formulation, successfully challenge the brand and defend attempts to negate the 180-day exclusivity. We anticipate significant benefits and value from our Simvastatin formulation to both patients and prescribers," said Malvinder Mohan Singh, CEO and Managing Director, RLL.
This FDA approval complements Ranbaxy's strategic direction for generics in the U.S. market with respect to this molecule as well as the 57 additional ANDA's that are pending before the FDA, placing Ranbaxy in a very strong, competitive position for the future.
"Ranbaxy is pleased to receive FDA approval for this blockbuster drug. We expect to launch Simvastatin 80mg on an exclusive basis immediately. We believe that by offering an affordably priced generic alternative, we will have a positive impact on the cost of healthcare for patients who have or are at high risk of coronary heart disease," noted Jim Meehan, Vice President of Sales and Marketing for RPI, USA.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 8 countries.
*Zocor is a registered trademark of MERCK & CO., Inc.