Vadodara-based Alembic Pharmaceuticals Ltd is eyeing to capitalise on the recent approval from the US drug regulator for extended release Desvenlafaxine base tablets, which is bio-equivalent of Pfizer's popular drug Pristiq (Desvenlafaxine Succinate) which went off patent recently.
The company expects significant revenue generation from the product, which will be marketed by Ranbaxy in the US market.
"We have recently received approval from US Food and Drug Administration (USFDA) for extended release Desvenlafaxine base tablets. This will add significant revenues to the company in coming months. Presently we are the only player in this segment to have received approval from the regulator," said Pranav Amin, executive director, Alembic Phrama. He, however, did not wish to elaborate on what was the revenue expectation from the drug. "It will take a while for the revenues from this product to get reflected on books," Amin said after the company's board meeting in Vadodara on Thursday.
Analysts, however, pointed out that the benefit to Alembic and Ranbaxy for the product will be limited as several other players have filed Para IV ANDAs of the same product. "However, including Alembic Pharma, five to six other players (like, Lupin, Cadila, Watson) has filed for Para IV ANDAs of the same, which are under litigation with the innovator. If these players get approval by the end of 2015, then Pristiq will not remain big opportunity for Ranbaxy and Alembic Pharma," analyst report by IndiaNivesh Securities Private Limited stated. 'Keeping view the genericisation of Pristiq by the end of 2015, we anticipate only two years of opportunity for Ranbaxy and Alembic. We assessed this product to contribute around Rs 90 crore of profit (post tax) in fiscal 2014 and Rs 110 crore in fiscal 2015 for Alembic and Ranbaxy each,' the analyst report claimed.
"Once the patent is gone, there would be some price erosion when multiple players start selling the generic product. But, even then there would be huge demand for the drug", explained R K Baheti, director, finance, Alembic.
Pfizer had sued Alembic to US court in June last year over alleged patent infringement with regards to its anti-depressant drug under the brand name Pristiq.
Other companies including Ahmedabad-based Cadila Healthcare were also in race to gain the 180-day exclusivity period to market the blockbuster drug in the US. Alembic, however, received the USFDA nod to market the drug in March this year.
Alembic has entered into an out-licensing agreement with Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL) to exclusively market Desvenlafaxine Base Extended Release tablets in the US healthcare system. Alembic and the company would manufacture the drug. According to estimates, the market size for Pristiq is $ 590 million (approx. Rs 3200 crore).