Indian business constituted about 16 percent of Dr Reddy’s Rs 15,385 crore revenues in FY19 compared to North America’s 39 percent.
The company anticipates US FDA approval for generic Nuvaring in the first half of FY20, while the launch of generic Copaxone in the US may get further delayed as the company received additional queries from the drug regulator relating to the product, the management said.
The companies have been accused of violating antitrust laws by fixing prices and allocating customers.
Sernivo Spray, Promiseb topical Cream and Trainex are the brands sold to US-based Encore Dermatology.
Indivior, a spin-off of British drug maker Reckitt Benckiser, had managed to block sales of Dr Reddy’s generic version of Suboxone Film through a court injunction since July on grounds of pending patent litigation
Rejecting arguments by Indivior, the judge left in force a ruling that allows DRL to put the generic drug on the market as early as February 20
Duvvada resolution is expected to give a huge fillip to the company, as around 20% of its future ANDA (abbreviated new drug applications) filings were made from this facility.
Out of 11, four are repetitive observations made by the agency in its inspection in 2017, while one observation goes even back to 2015 inspection.
Net Sales are expected to increase by 4.7 percent Y-o-Y (up 5.2 percent Q-o-Q) to Rs. 4,015.2 crore, according to ICICI Direct.
Chandan Taparia of Motilal Oswal Securities sees immediate resistance for the Bank Nifty at 26,250-26,333 levels
Dr Reddy's had booked sales of around $10-15 million days after its launch before it was stayed by the court.
The revenue rose to Rs 3,797.8 crore against Rs 3,546 crore that the company posted during the corresponding quarter of last year. This implies a rise of 7 percent.
The effect of Suboxone based on US court order is likely to weigh as well.
The drug maker's partner Fresenius Kabi has completed clinical trial for Pegfilgrastim and announced that the drug has met primary end point in two pivotal clinical studies.
Net Sales are expected to increase by 8.4 percent Y-o-Y (up 3.2 percent Q-o-Q) to Rs. 3,857.7 crore, according to ICICI Direct.
Dr Reddy's Neostigmine Methylsulfate injection, USP is available in strengths of 5 mg/10 ml and 10 mg/10 ml in multi-dose vials.
Under the expedited schedule ordered by the US Court of Appeals for the Federal Circuit, arguments will be held during the first week of October
Revenue during the quarter grew 12 percent to Rs 3,721 crore compared to Rs 3,316 crore in the same quarter last year.
The company will also benefit with sales of US complex generic portfolio holding out despite pricing pressure and lack of major approvals.
The company is recalling the bottles on account of "failed impurities/degradation specifications," according regulator US Food and Drug Administration (USFDA).
Indivior, the innovator of the drug, had moved an injunction motion against Dr Reddy's to block the company from selling generic Suboxone in US
The BSE Healthcare index gained 6.28 percent in the past week, while the benchmark Sensex increased 0.42 percent
The court has scheduled an expedited hearing of the preliminary injunction on June 28, and a ruling is expected soon thereafter
The Suboxone brand had US sales of around $1.86 billion for the 12 months ended April 2018, according to IQVIA.
The US FDA conducted audit at its active pharmaceutical ingredient (API) Srikakulam special economic zone (SEZ) plant this week.