Lupin to pay Rs 1824 crore to settle diabetes drug Glumetza suit in US
New Delhi: In an out-of-court settlement, Indian generic drug maker Lupin Pharmaceuticals Inc has decided to pay the Direct Purchaser Group Rs 1,103 crore (USD150 million) and the Retailer Opt-Out group Rs 721 crore (USD 98 million) to resolve an antitrust lawsuit alleging the company's involvement in a scheme to delay generic versions of the bestselling diabetes drug Glumetza in the United States.
This came after multiple antitrust class actions were filed in the Northern District of California, U.S. against several stakeholders, including Lupin Ltd. and its subsidiary Lupin Pharmaceuticals, Inc., U.S., in connection with Glumetza, a drug for the treatment of diabetes, the company stated in its filing.
Two of the plaintiffs separately representing the majority of the claims against Lupin are collectively addressed as the Direct Purchaser Group and the Retailer Opt-Out Group.
Glumetza, an extended-release version of the drug metformin, was approved by the U.S. Food and Drug Administration in 2005 and originally sold by Depomed Inc, now called Assertio. Depomed marketed the drug with Santarus Inc., which Bausch later acquired.
GLUMETZA is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
The lawsuits filed against the drug-maker Lupin alleged that the 2012 settlement of patent litigation regarding Glumetza delayed the availability of generic alternatives, causing consumers to pay higher prices for the drug.
In 2009, Depomed sued Lupin after it applied for FDA approval of a generic version of Glumetza, alleging the generic would infringe its patents.
However, the parties settled in 2012, with Lupin delaying its generic until 2016 in exchange for a payment and an agreement for the Glumetza makers not to compete with Lupin's generic with their own authorized generic during its market-exclusivity period, reports Reuters.
As a consequence, the purchasers accused the Laval, Canada-based company and Lake Forest, Illinois-based Assertio Therapeutics Inc. of paying Lupin to postpone the launch of its generic version of the Type 2 diabetes drug in exchange for agreeing not to compete with the generic, reports Reuters.
The complaint further said the scheme had caused the purchasers to overpay for the drug by more than $2.8 billion. As per the allegation, the scheme had raised the drug's price by nearly 800%, according to a filing in San Francisco federal court, reports Reuthers.
In relation to the above, the Glumetza purchasers sued Bausch, Lupin, Assertio, and others in 2019 over the arrangement. They argued it unlawfully allowed Bausch to hike the drug's price in 2015 from its fair value of less than $55 for a 30-day supply to more than $3,000 for the brand-name drug and $2,200 for generics.
The drug major Lupin disputed these claims and defended these matters vigorously. The trial for this case was scheduled to begin on October 4, 2021, in the U.S. courts.
According to a Bloomberg report, Bausch Health Cos Inc and Assertio Therapeutics Inc have already settled the issue with other stakeholders against whom antitrust class lawsuits were launched.
As per Reuters, Glumetza's maker, Bausch Health Cos Inc, agreed to pay USD 300 million and Assertio would pay more than USD 3.8 million to settle the purchasers' antitrust allegations.
With a view to resolving this dispute, considering that other defendants have recently settled cases and in light of the increased uncertainty, the drug maker Lupin has agreed to settle with the plaintiffs for an amount of US $150 million (US Dollar One Hundred and Fifty million) with the Direct Purchaser Group (subject to the court's approval) and US $98 million (US Dollar Ninety Eight million) with the Retailer Opt-Out Group.
"This settlement will have no significant impact on the Company's financial position," the company stated in its filing.