Dr. Reddy’s faces antitrust litigation in the U.S over cancer drug

INDIA — Dr. Reddy’s Laboratories and a few other drugmakers have been named defendants in a complaint filed in the U.S. under the Federal and State antitrust laws over cancer drug Revlimid.

In a regulatory filing, the company said a complaint was filed on November 18, 2022, in the District of New Jersey, USA, and it along with other generic pharmaceutical firms including Celgene and Bristol Myers Squibb have been named as defendants.

The complaint, which purports to be on behalf of a class of indirect purchasers, asserts claims under federal and state antitrust laws and other state laws alleging that the defendants improperly restrained competition and maintained a shared monopoly in the sale of brand and generic Revlimid through their respective settlements of patent litigation,Dr. Reddy’s Laboratories said.

Patent settlements, such as the one signed by Dr. Reddy’s with BMS in 2020, delayed generic companies’ entry into the market with their knockoffs until pre-specified dates. Dr. Reddy’s agreement also included a limited-volume generic launch earlier this year.

According to the lawsuit, deals like these allowed BMS and generics makers to maintain their monopoly and keep prices high.

According to the lawsuit, fair competition would have resulted in a price of US$800 for a 30-day supply of Revlimid.

Revlimid is a prescription medicine, used to treat adults with multiple myeloma (MM) in combination with dexamethasone, or as maintenance treatment after a type of stem cell transplant that uses an individual’s own stem cells.

The complaint also alleges that the challenged agreements improperly delayed generic entry entirely until 2022 and then improperly limited competition through 2026.

The complaint seeks damages for purported overpayments and equitable relief, it added.

Dr. Reddy’s asserted that “the allegations against it lack merit and will vigorously defend the litigation.”

Revlimid won its first approval in the United States in 2005. Five years later, Natco created a generic version of the drug, triggering a patent infringement lawsuit from Celgene.

Since then, Celgene and BMS have been in court fending off Natco and other producers of generics with so-called “pay-for-delay” deals.

Staying on the litigation front, the sprawling, five-year-long litigation over the U.S. opioid crisis appears to be entering its final phase with finalized agreements by Teva Pharmaceutical Industries Ltd and AbbVie Inc.

There are tentative agreements by CVS Health Corp, Walgreens Boots Alliance Inc, and Walmart Inc to settle with state, local and tribal governments.

Smaller pharmacy operators, including Rite Aid Corp and Kroger Co, have yet to settle. But the deal by the nation’s largest retail pharmacies adds to previous settlements with drugmakers and the largest U.S. distributors.

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