 "Dr Reddy's gains over 3% on new drug launch in the US market")
Shares of Dr Reddy’s Laboratories were up 3.4 per cent to Rs 4,553.70 on the BSE in Monday’s trade in an otherwise weak market after they launched generic version of fesoterodine fumarate extended-release tablets to treat overactive bladder in the US market.
The company along with its subsidiaries announced the launch of Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) extended-release tablets in the U.S. market approved by the U.S. Food and Drug Administration (USFDA). The company’s fesoterodine fumarate extended-release tablets are available in 4 mg and 8 mg tablets, each in bottle count sizes of 30.
According to IQVIA, the Toviaz brand had sales of approximately $211 million MAT in the US over twelve months that ended in May 2022.
Meanwhile, last week USFDA completed pre-approval inspection (PAI) of the company’s formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh. The company has been issued a Form 483 with two observations, which the company said it will address within the stipulated timeline.
In the past three months, Dr Reddy’s outperformed the market by gaining 4 per cent, against 8 per cent decline in the S&P BSE Sensex. However, it has slipped 17 per cent in a year as compared to 3.5 per cent rise in the benchmark index.
Analysts at Nirmal Bang expect the company to deliver growth across their business segments. "In North America, which is the single largest market for the company, it has multiple limited competition opportunities targeted through its pipeline and gRevlimid is one of them that will fructify in the near term," the brokerage firm said.
That apart, they also foresee the company to make progress in improving its rankings in India. The company targets Nutraceuticals and OTC segments in India, where it currently has a small presence, but has larger aspirations. Emerging Markets (EM) should also continue to grow as the company will continue to expand its portfolio and footprint.
The company along with its subsidiaries announced the launch of Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) extended-release tablets in the U.S. market approved by the U.S. Food and Drug Administration (USFDA). The company’s fesoterodine fumarate extended-release tablets are available in 4 mg and 8 mg tablets, each in bottle count sizes of 30.
According to IQVIA, the Toviaz brand had sales of approximately $211 million MAT in the US over twelve months that ended in May 2022.
Meanwhile, last week USFDA completed pre-approval inspection (PAI) of the company’s formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh. The company has been issued a Form 483 with two observations, which the company said it will address within the stipulated timeline.
In the past three months, Dr Reddy’s outperformed the market by gaining 4 per cent, against 8 per cent decline in the S&P BSE Sensex. However, it has slipped 17 per cent in a year as compared to 3.5 per cent rise in the benchmark index.
Analysts at Nirmal Bang expect the company to deliver growth across their business segments. "In North America, which is the single largest market for the company, it has multiple limited competition opportunities targeted through its pipeline and gRevlimid is one of them that will fructify in the near term," the brokerage firm said.
That apart, they also foresee the company to make progress in improving its rankings in India. The company targets Nutraceuticals and OTC segments in India, where it currently has a small presence, but has larger aspirations. Emerging Markets (EM) should also continue to grow as the company will continue to expand its portfolio and footprint.
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