Shares of Dr. Reddy’s Laboratories rose nearly 4% in intraday trade on Monday, in an otherwise weak broader market, after the drugmaker announced the launch of Fesoterodine Fumarate extended-release tablets in the U.S. market. The drug is a therapeutic generic equivalent to Toviaz (fesoterodine fumarate) extended-release tablets, which are used in the treatment of certain bladder-related problems.
Aided by the development, Dr Reddy’s shares opened higher at ₹4,415 as compared to Friday’s closing price of ₹4,403.5 on the BSE. During the session, so far, the stock gained as much as 3.7% to hit an intraday high of ₹4,568. On the volume front, 0.11 lakh shares worth ₹4.92 crore changed hands over the counter on the BSE against a two-week average volume of 0.14 lakh stocks. The market capitalisation of the large cap pharma stock rose to ₹75,002 crore. In contrast, the BSE benchmark Sensex was trading 283 points lower at 54,198 levels.
The pharma major in a post market hours release on Friday said it has received the U.S. Food and Drug Administration (USFDA) approval to launch Fesoterodine Fumarate extended-release tablets in the American market. “Dr. Reddy’s Laboratories announces 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 following the approval by the U.S. Food and Drug Administration (USFDA),” it said in a BSE filing.
As per the release, the Toviaz brand had U.S. sales of approximately $211 million moving annual total (MAT) for the most recent twelve months ending in May 2022 according to IQVIA, an American clinical research firm. The tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30.
In a separate development, the drug major has recently got a major relief in a patent litigation case by a U.S. court. On June 28, the United States Court ruled in favour of the Hyderabad-based firm in a patent case pertaining to a generic version of the UK-based Indivior opioid treatment Suboxone sublingual film. The court dismissed all claims and counterclaims filed by Indivior Inc. and Indivior UK Limited, and Aquestive Therapeutics related to the company’s generic buprenorphine and naloxone sublingual film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg dosages, a therapeutic equivalent generic version of Suboxone sublingual film in the U.S.
“The stipulation of dismissal was filed pursuant to a settlement agreement that the Company entered into with Indivior and Aquestive. The settlement and dismissal resolves all claims between the parties, including Indivior’s and Aquestive’s claims for patent infringement as well as the Company’s antitrust counterclaim against Indivior,” the drugmaker said in a BSE filing on June 29.
The board of the company is set to meet on June 28 to consider and approve the financial results of the quarter ending on June 30, 2022.