News Feature | January 22, 2014

Novo Nordisk Faces Anti-Competitive Practices Charges

Source: Outsourced Pharma

By Estel Grace Masangkay

Drug distribution and healthcare purchasing companies in the US have filed anti-competitive practices charges against Danish pharmaceutical giant Novo Nordisk for allegedly keeping less expensive generic copies of Prandin off the market and forcing customers to pay inflated prices for the drug. Novo Nordisk reportedly makes $200 to $250 million in US sales from Prandin.

Prandin (repaglinide) is a diabetes drug used to improve glycemic control for adult patients with Type 2 diabetes in conjunction with proper diet and exercise. Healthcare purchasing companies American Sales Co., Rochester Drug Co-op, and Cardinal said that Novo Nordisk wrongfully delayed generic competition for the drug. The companies are seeking compensation for lost earnings.

Rival company Caraco Pharmaceutical Laboratories, a subsidiary of India-based Sun Pharmaceutical Industries, was awarded approval to sell a generic version of Prandin last June. Novo Nordisk filed a patent infringement lawsuit against Caraco, which the court dismissed. Novo Nordisk also attempted to extend its patent by combining Prandin with metformin, called Prandimet. The combination was intended to pass through the Orange Book of approved drugs in the U.S., but was also rejected. The ruling could potentially impact future decisions of both brand and generic companies under the Orange Book use code listing and practice of challenge strategies. It also opened the door to the introduction of a generic version of Prandin. Sun Pharmaceutical won a subsidiary final approval for its Abbreviated New Drug Applications (ANDA) to market Repaglinide tablets last year.

If the drug distribution companies win their case against Novo Nordisk, damages will be awarded based on calculation of Prandin’s price when the generic version should have entered the market. While similar cases tend to end in settlement between parties, Novo Nordisk reportedly said it will attempt to have the anti-competitive practices case dismissed from the court.

Source:
http://cphpost.dk/news/novo-nordisk-sued-over-anti-competitive-practices.8354.html