FDA approves Ranbaxy’s generic Lipitor
pharmafile | December 1, 2011 | News story | Manufacturing and Production, Sales and Marketing | Lipitor, Pfizer, Ranbaxy, Teva
The FDA will allow Ranbaxy to develop a generic version of Pfizer’s blockbuster statin Lipitor.
The firm has received final approval from the US regulator to manufacture and market generic forms of Pfizer’s anti-cholesterol drug Lipitor (atorvastatin), and has now launched the product in the US market.
The decision comes a day after Lipitor went off patent in the US, which had made Pfizer $7.89 billion in US sales so far this year.
At its peak Lipitor was generating over $13 billion in total annual sales, making it the biggest selling the drug in the world.
Ranbaxy said it would collaborate with the leading generic drug maker Teva on making atorvastatin.
Teva said as part of this deal it would receive a portion of the profits from Ranbaxy’s sales of atorvastatin during Ranbaxy’s 180-day first-to-file exclusivity period, but did not disclose financial details of the deal or how the firms would be collaborating.
This approval looked in doubt after the Indian firm, a subsidiary of Daiichi Sankyo, has had to deal with a number of problems with its version of the drug.
The firm has been in dispute with the FDA since 2008 when the Agency gave Ranbaxy an import ban over manufacturing violations at two plants in India, where it would have been manufacturing its form of Lipitor.
Today’s FDA approval was for products made at a plant in New Jersey which may have been contingent on the deal with Teva, said Bino Pathiparampil, a healthcare analyst speaking to Bloomberg.
Copycat Lipitor may generate as much as $650 million for Ranbaxy in its first 180 days of sale, according to analysts.
Arun Sawhney, chief executive and managing director of Ranbaxy, said: “Atorvastatin helps millions of Americans manage healthy cholesterol levels, and we are pleased to have received US FDA approval to manufacture and market a safe, effective, affordable and accessible alternative to branded Lipitor.
“We are committed to continuing to expand our portfolio of products offered in the US market for the benefit of patients, prescribers and the US healthcare system,” he added.
Yesterday Watson Pharmaceuticals starting to distribute generic Lipitor in conjunction with Pfizer, which will keep 70% of the revenue from drug.
Watson will not be making its own version of the drug as this will come from Pfizer, but it will be responsible for marketing and distributing the drug in the US.
Lipitor will start to go off patent across Europe from mid-2012, and has now lost exclusivity in the US, Spain, Brazil and Mexico.
The firm extended its patent across Europe by six months after it was granted a paediatric licence for the drug.
Ben Adams
Related Content
Teva announces positive results from trial of AJOVY for migraine
Teva has announced positive results from the phase 4 PEARL study of AJOVY (fremanezumab), its …
NICE recommends Pfizer’s new once-weekly treatment for haemophilia B on NHS
Walton Oaks, 21st May 2025 – Pfizer Ltd announced today that the National Institute for Health and Care …
Pfizer releases results for severe RSV-associated LRTD treatment study
US-based Pfizer have announced results from its substudy B of the ongoing phase 3 clinical …
