AstraZeneca loses major generics appeal in India
The Delhi High Court has cleared the way for a slew of generic diabetes drugs to arrive on the Indian market after it rejected AstraZeneca’s request for a blocking order.
In a decision handed down Tuesday, July 20, the court denied AstraZeneca’s appeal for a restraining order against nine generic makers. The decision means those companies, including Intas and Torrent Pharmaceuticals, will be able to launch their own generic versions of AstraZeneca’s dapagliflozin, the active ingredient in blockbuster drug Farxiga.
AstraZeneca reported Farxiga sales worth more than $1.96 billion in 2020, making it one of the drugmaker’s best performing products. Farxiga was first approved by the US Food and Drug Administration (FDA) in 2014, while last year the FDA expanded its approved uses into the treatment of heart failure.
The legal dispute between AstraZeneca and its rivals centres on the validity of its most recent Indian patent covering dapagliflozin. The patent is set to expire in 2023, but the court found it lacked inventiveness over what was already claimed in an earlier patent, which expired last year. In Wednesday’s decision, the court said it could not “find any difference” between the two patents.
“In our opinion, a single formulation as [dapagliflozin], is incapable of protection under two separate patents having separate validity period. The appellants/plaintiffs, in their pleadings, are not found to have pleaded the difference, save for pleading that [dapagliflozin] was discovered by further research,” the judgment said.
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