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Dr Reddy's Labs tumbles as Amneal Pharma to launch first generic NuvaRing

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Capital Market
Last Updated : Dec 13 2019 | 1:31 PM IST

Dr Reddy's Laboratories fell 3.02% to Rs 2817.80 after US-based Amneal Pharmaceuticals beat the Indian drug maker to launch generic version of a branded birth control product.

The stock traded in the range of Rs 2774 and Rs 2870 so far during the day.

Amneal Pharmaceuticals, in press release dated 12 December 2019, said that it has received abbreviated new drug application (ANDA) approval from the U.S. Food and Drug Administration (USFDA) for EluRyng (etonogestrel/ethinyl estradiol vaginal ring), the first generic version of NuvaRing. Amneal has initiated commercialization activities for EluRyng, which is being manufactured internally and launching on 12 December.

According to IQVIA database, NuvaRing U.S. annual sales for the 12 months ended October 31, 2019 were approximately $976 million.

In June 2016, Dr Reddy's Laboratories had entered into a definitive purchase agreement with Teva Pharmaceutical Industries and an affiliate of Allergan plc to acquire eight Abbreviated New Drug Applications (ANDAs) in the United States for $350 million in cash.

Ethinyl estradiol/Ethonogestrel Vaginal Ring, a generic equivalent to NuvaRing, was one of the ANDAs acquired by the company from Teva Pharmaceuticals for $185 million.

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In Q1 June 2018 earnings conference call, Erez Israeli, CEO of Dr Reddy's Laboratories, had said that the company expects to launch its generic Nuvaring in the first half of calendar 2019.

In August this year, Dr Reddy's Laboratories said that it had received a Complete Response Letter (CRL) from USFDA and is preparing its response to the USFDA. Reports add that the launch got delayed by 10-12 months because of the USFDA response letter.

On a consolidated basis, Dr Reddy's Laboratories' net profit rose 113.5% to Rs 1106.80 crore on a 26.4% increase in net sales to Rs 4800.80 crore in Q1 June 2019 over Q1 June 2018.

Dr. Reddy's Laboratories is an integrated pharmaceutical company.

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First Published: Dec 13 2019 | 12:39 PM IST

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