Lipitor Goes Generic, But First-Filer Ranbaxy’s Approval Leaves Plenty Of Questions In Its Wake
Executive Summary
Ranbaxy launches generic atorvastatin despite not having reached a final settlement with FDA on GMP violations and data integrity issues. Teva’s role in Ranbaxy’s approval and launch is unclear, although the company will get a cut of the first-filer’s profits during the 180-day exclusivity period.
You may also be interested in...
Pfizer Reaches $93m Deal On Decade-Old Lipitor Antitrust Suit
An antitrust lawsuit accusing Pfizer of conspiring to delay generic competition to its Lipitor blockbuster came soon after generics entered the US market in November 2011. Only now, after a decade of back and forth, has a deal been agreed to dismiss the accusations.
Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.
Where’s Generic Diovan? Ranbaxy’s Valsartan ANDA In Limbo As Novartis’ Patent Expires
Apparent first-filer Ranbaxy failed to receive ANDA final approval upon expiration of Novartis’ compound patent for the antihypertensive, raising questions as to whether the Indian company’s opportunity on generic Diovan will be compromised by its GMP consent decree with FDA.