Sun Wins FDA Approval of Generic Version of Merck’s Proscar®, Propecia®

Not a surprise, but news of additional erosion of Merck’s branded legacy drug franchises, Proscar® and Propecia®, here. This approval brings the total of approved generic versions to at least seven; none of which require a prescription, while Merck’s branded offerings still do. Ouch.

The link to the FDA order granting approval to Sun is here. Here is a shortish blurb from a drug industry source, on Mumbai-based Sun’s recent generic approval news:

. . . .Generic drug maker Sun Pharmaceutical Industries has received regulatory approval for a drug designed to treat an enlarged prostate and hair loss in men. . . . Sun Pharma’s finasteride tablets in the 5-mg strength were approved on Aug. 16.

Finasteride is the generic equivalent of Proscar and Propecia, which are made by Merck. . . .

So it goes — as the industry-wide generic/off-patent cliff approaches. Lipitor® (at Pfizer) is next up; the $12 billion a year franchise goes generic in about two months’ time.


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