Dr. Reddy’s, which has been dealing with repeated manufacturing setbacks from the FDA, is now facing a new regulatory challenge. It has received a complete response letter for two potentially very lucrative products, generic versions of Teva’s Copaxone and Merck’s birth control device NuvaRing.
The Indian drugmaker made a public announcement today after the CRL was reported by Bloomberg. The company initially disclosed it by inserting the fact onto page 8 of a 16-page investor presentation on its website.
Dr. Reddy’s provided no details about the FDA action, like whether the agency was dissatisfied with its versions, or whether the delay was related to it ongoing manufacturing issues. It said in its filing that it is that it told investors last month that the FDA was making inquiries about its NuvaRing copy. It also said it is preparing a response.
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The setback is particularly good news for Merck & Co., which lost patent protection for NuvaRing last year. There has yet to be a copy for the drug, so the first to market copy has the chance to win some significant sales. Merck reported 2018 global sales for NuvaRing at $902 million, a 19% jump.
Copaxone is a different story. Generics from Sandoz and Mylan began rolling out in 2016 and 2017 and have been gobbling up Teva’s market share. The Israeli drugmaker reported 2018 Copaxone sales of $1.76 billion, a stunning 44% decline from 2017. Still, for Dr. Reddy’s a shot at some of Teva’s remaining U.S. Copaxone sales would be a big shot in the arm.
Dr. Reddy’s has told investors that the only way to overcome shrinking generics prices in the U.S. market, where its sales have fallen, is with new launches. The Indian company has also had its ability to launch some new drugs curtailed by its on-going manufacturing setbacks. It did win approval of a generic of Pfizer pain drug Lyrica last month, but so did nine other companies.
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In 2015, the FDA issued a scathing three-facility warning letter for a long list of manufacturing and data integrity irregularities. One of those facilities, Dr. Reddy’s long-troubled oncology formulations plant in Duvvada, India, was upgraded this year to Voluntary Action Indicated, but it continues to struggle with is production standards throughout its manufacturing network. It has received four Form 483s from the FDA this year.
