Sun Pharma agreed to pay $485 Million to settle claims that Ranbaxy’s faulty U.S. Food and Drug Administration (FDA approval filings) were made to prevent other generic drugs from entering the market.
Sun, the Indian pharmaceutical giant Ranbaxy, was purchased by Sun in 2014 for a reported $3.2Billion. FiercePharma reports that Sun has not admitted to any wrongdoing in the settlement.
Ranbaxy was accused by generic drug buyers of violating state consumer protection laws as well as federal antitrust laws. He submitted flimsy FDA approval applications that contained false or missing information.
Sun’s attempt to dismiss the class-action lawsuit was unsuccessful in November, FiercePharma reports. The complaint itself was consolidated in 2019.
Ranbaxy was awarded exclusive rights for generic versions of drug products after the FDA fraudulent applications were submitted. This included AstraZeneca’s stomach-acid drug Nexium and Novartis’ blood pressure drug Diovan. Also, Roche’s herpes drug Valcyte. FiercePharma reports.
Ranbaxy received FDA approval in 2014 for its generic Diovan version.
Ranbaxy’s Faulty FDA Application Caused Higher Drug Price
Buyers claimed that the faulty applications prevented competitors from entering the market, and led to an increase in drug prices.
Sun also had issues with Ranbaxy’s four manufacturing plants after it bought the company. These locations were closed by the FDA because of quality problems.
FiercePharma reports that the FDA consent decree allowed the manufacturing plants to continue operating while they were being monitored by outside auditors.
FDA revoked tentative approvals Ranbaxy for generic Nexium/Valcyte drugs due to manufacturing problems.
Teva Pharmaceuticals was the subject of a similar class-action lawsuit. The limited liability company claimed that Teva had suppressed market competition to produce generic versions of Copaxone, its multiple sclerosis drug.