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Lupin obtains FDA OK for generic Prezista

Prezista is used to treat HIV-1 infection in adults.
Levy

Lupin has received the Food and Drug Administration’s permission for darunavirt tablets, 600 mg and 800 mg.

The medication, which is a generic of Janssen's Prezista, is used to treat HIV-1 infection in adults.

[Read more: Lupin receives FDA OK for generic Banzel]

Lupin shared that it is the exclusive first filer for 800 mg tablets and is eligible for 180-day exclusivity.

The company also will potentially have shared 180-day exclusivity on 600 mg tablets, which will be manufactured at its facility in Nagpur, India.

[Read more: Lupin receives FDA OK for generic Edarbi]

Darunavir tablets, 600 mg and 800 mg have a market value of roughly $343 million, according to IQVIA June 2022 data.

 

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