Mylan Launches Generic Version Of Novo Nordisk's Prandin
Mylan announced that its U.S. subsidiary has launched a generic version of Novo Nordisk’s Prandin. Mylan’s generic tablets are marketed as Repaglinide and available in 0.5 mg, 1 mg, and 2 mg variants.
Repaglinide is an oral antidiabetic agent used to increase glycemic control in adults with type 2 diabetes mellitus. Type 2 diabetes is also known as non-insulin-dependent diabetes mellitus or maturity onset diabetes. Patients are recommended to use the drug in conjunction with proper diet and exercise to control blood sugar levels.
Repaglinide tablets are not recommended for patients with Type 1 diabetes or diabetic ketoacidosis. Patients who are using gemfibrozil and NPH-insulin are not advised to use the drug, as well as those who are hypersensitive to Repaglinide.
The U.S. Food and Drug Administration (FDA) granted Mylan final approval for its Repaglinide Abbreviated New Drug Application (ANDA). According to IMS Health, Repaglinide had estimated sales of over $210 million in the US as of September 2013.
Danish company Novo Nordisk reportedly makes up to $250 million from its sales of Prandin in the US market. The pharmaceutical giant was recently accused by drug distribution companies of anti-competitive practices for keeping less expensive generic copies of the drug like Repaglinide off the market. Healthcare purchasing companies allege that Novo Nordisk’s strategy forced people to pay inflated prices for the drug, causing them lose potential earnings. Complainants against the Danish pharmaceutical company include American Sales Co., Cardinal, and Rochester Drug Co-op. Novo Nordisk said it will try to get the case dismissed.
Novo Nordisk also made efforts to extend its patent by combining Prandin with metformin under the name Prandimet. The FDA rejected the application, opening the door to companies like Mylan to sell generic versions of Prandin.
Source:
http://investor.mylan.com/releasedetail.cfm?ReleaseID=820886