Sun Pharma Class Action ResolvedFor $485M, Ending Antitrust Claims Against Predecessor Ranbaxy

Sun Pharma, Ranbaxy FDA Approval Applications Class Action Lawsuit Overview: 

• Who: Sun Pharma agrees to pay $485 million to resolve class action claims made against its predecessor, Ranbaxy.
• Why: A class of generic drug buyers claimed Ranbaxy broke federal antitrust laws by filing fraudulent approval filings with the U.S. Food and Drug Administration.
• Where: The class action lawsuit was filed in Massachusetts federal court.

Sun Pharma has agreed to pay $485 million to resolve claims that faulty U.S. Food and Drug Administration (FDA) approval filings made by its predecessor Ranbaxy were done to keep other low-priced generic drugs off the market. 

Sun, which purchased the Indian pharmaceutical giant Ranbaxy back in 2014 in a deal worth a reported $3.2 billion dollars, is not admitting to committing any wrongdoing by agreeing to the settlement, FiercePharma reports.  

A class of generic drug buyers claimed Ranbaxy had violated state consumer protection laws and federal antitrust laws by submitting flimsy applications for FDA approval that contained information that was fraudulent or missing. 

Sun’s bid to get the class action lawsuit dismissed came up short in November, FiercePharma reports, while the complaint itself was consolidated in 2019. 

Generic drug buyers claimed the fraudulent FDA applications earned Ranbaxy 180-day exclusivity rights for generic versions of drugs that included AstraZeneca’s stomach-acid drug Nexium, Novartis’ blood pressure drug Diovan and Roche’s herpes antiviral drug Valcyte, FiercePharma reports.

Ranbaxy was awarded FDA approval for its generic version of Diovan in 2014. 

Ranbaxy’s Faulty FDA Applications Caused Higher Drug Prices

The faulty applications kept competitors from being able to enter the market and caused drug prices to increase, the buyers claimed. 

Sun also took on issues with four of Ranbaxy’s manufacturing plants when it purchased the company with the locations shut down by the FDA due to problems with quality. 

The manufacturing plants had only been operating under an FDA consent decree that allowed them to remain open while being monitored by outside auditors, FiercePharma reports. 

Manufacturing problems caused the FDA to revoke the tentative approvals Ranbaxy had been given for the generic Nexium and Valcyte drugs. 

A similar class action lawsuit was filed against Teva Pharmaceuticals earlier this month by a limited liability company claiming Teva had suppressed the market competition for generic versions of its multiple sclerosis drug Copaxone. 

Have you purchased the generic versions of drugs sold by Sun Pharma or, previously, Ranbaxy? Let us know in the comments!

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