More troubles ahead for Dr Reddy, as FDA scuppers generic products.


Dr Reddy is receiving another regulatory challenge today (after repeated manufacturing setbacks) in the form of an FDA process refusing two of its lucrative generic products. These would be Teva’s Copaxone and Merck’s birth control device NuvaRing.

The company has not revealed where the issues lay in the FDA letter, such as whether the FDA was dissatisfied with the generics or whether it was part of the ongoing manufacturing issue. Dr Reddy has since announced that it will be filing a response to the letter.

This is not a new problem for Dr Reddy, when back in 2015 it received a scathing review/warning of three of its facilities regarding a long list of manufacturing and data irregularities. With one of these facilities being the oncology division, where it continues to this day to struggle with production standards, receiving four Form 483s from the FDA this year alone.

However, there is good news for some as Merck will undoubtedly be pleased, as it lost patent protection for NuvaRing last year and has yet to face generic competition. With the company that makes the first generic set to make a healthy cut, as Merck reported global sales for NuvaRing in 2018 as $902million.

The same cannot be said for Teva pharmaceuticals, where there are multiple generics for Copaxone from Sandoz and Mylan which have been quickly eating away at Copaxone sales to $1.76billion in 2018, a staggering 44% drop from 2017.


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