Mylan received approval from FDA to market its desvenlafaxine extended-release tablets, the generic version of Pristiq (Pfizer), for major depressive disorder. Plus, 2 other manufacturers recently received approval for their generic versions of Pristiq.
Mylan received approval from FDA to market its desvenlafaxine extended-release (ER) tablets, the generic version of Pristiq (Pfizer), for major depressive disorder. Plus, 2 other manufacturers recently received approval for their generic versions of Pristiq.
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Desvenlafaxine ER tablets, 50 mg and 100 mg, had US sales of approximately $853 million for the 12 months ending January 31, 2017, according to IMS Health.
In addition, Teva Pharmaceuticals and Lupin received approval for their generic versions of Pristiq on March 1. Teva launched desvenlafaxine ER tablets in 25 mg, 50 mg, and 100 mg doses, while Lupin launched desvenlafaxine succinate ER tablets form in 50 mg and 100 mg.
Related: Industry pushes for faster generic approvals as costs rise
Pfizer will take a hit from the generic competition, and estimated that it will have about $578 million at risk this year due to patent expirations. Plus, in the fourth quarter of this year, Pfizer’s Viagra loses patent protection, which is expected to significantly claw into Pfizer’s estimated $1.2 billion in sales of the drug.
Pristiq was launched in 2008, as part of a class of serotonin-norepinephrine reuptake inhibitors (SNRIs). Pristiq affects the levels of norepinephrine and serotonin, which play a role in depression.
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