Launch of a generic version of Prilosec OTC to help DRL gain Rs 103-108 crore.
Dr Reddy’s Laboratories (DRL), which won a favourable verdict in a patent litigation in the United States in relation to an over-the-counter (OTC) generic version of AstraZeneca’s heart-burn drug, Prilosec, is likely to earn up to $20-35 million (Rs 103-180 crore) in the next financial year from selling this drug, according to analysts.
A Goldman Sachs analysis said that depending on the timing of the US Food and Drug Administration’s (FDA’s) final approval and when DRL launches the drug, the generic product could generate $20-35 million in sales in 2009-10.
“This reaffirms our analysis that DRL is on course to post 8 per cent sales growth in the US market and overall sales growth of 10 per cent for FY10,” said the report. It said the court’s ruling cleared a major hurdle for DRL in launching a generic version of Prilosec OTC.
The OTC brand product clocked sales of over $360 million in the US in 2008. The OTC version of the drug was granted approval by the FDA in 2003, with a three-year marketing exclusivity. Perrigo Pharmaceutical is the only other player to have launched a generic version of OTC Prilosec following its patent litigation settlement with Astra Zeneca in December 2007, according to sources.
DRL had filed a Para IV abbreviated new drug application (ANDA) — which notifies to challenge the patent rights of the innovator — in 2008. Following this, AstraZeneca initiated litigation against DRL for patent infringement. According to the US rules on generic drugs, the innovator has to challenge the Para IV filer within 45 days to block the launch of the generic product for the next 30 months.
The US District Court of New York, on March 10, had dismissed AstraZeneca’s patent lawsuit against Dr Reddy’s Labs. The court agreed that the defendant, DRL, used a different form of omeprazole magnesium (the active pharmaceutical ingredient in Prilosec) and hence did not infringe on AstraZeneca’s patents. AstraZeneca’s form of omeprazole magnesiumhas at least has 70 per cent crystalline base and has a unique water-based process used to produce the drug. DrReddy’s developed a different form of omeprazole magnesium having less than 1 per cent crystalline form and used a different manufacturing process, said patent experts.
DRL said the FDA had requested additional data to support its ANDA and its approval could come any time within the next few months.
“We will continue to work through the regulatory approval process while simultaneously progressing manufacturing and commercialisation preparation,” said Amit Patel, head, North America generics, Dr Reddy’s Laboratories.
