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| Sun loses $3-bn revenue potential from US |
| BS Reporter / Mumbai Dec 01, 2008, 22:05 IST |
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Osmotica pips Indian firm to get FDA nod for selling anti-depressant.
 Sun Pharmaceutical Industries, India's largest drug maker by market value, has lost out on a $3-billion revenue potential from the US market after a rival beat it to gain the US regulator’s approval to sell the world’s best-selling anti-depressant.
The US Food and Drug Administration (FDA) recently benchmarked further generic approvals of the tablet form of Effexor XR (Venlafaxine) to the US-based Osmotica Pharmaceutical's marketing application. The approval makes Sun Pharma's marketing application (abbreviated new drug application or ANDA) invalid.
Now, Sun Pharma will have to conduct fresh bio-equivalence study comparing with Osmotica's tablets and resubmit their ANDA, which effectively prevents its plans of launching the drug in the US market.
Effexor XR extended release drug in capsule form had annual sales of $3 billion for the month ended September 2008 and is the largest selling drug of Wyeth. Osmotica has already launched its tablet version following the product patent expiry of the basic ingredient in June, this year.
"The resubmission and approval of fresh ANDA after conducting bio-equivalence studies will take over two years. Sun Pharma was expecting US FDA approval for this drug in the third quarter of this financial year," said Ranjit Kapadia, head of life science research, Prabhudas Lilladher.
Unlike normal patent challenges by generic companies, Osmotica and Sun Pharma developed an improvised tablet form of the drug and challenged the patent on basic ingredient venlafaxine, and not the original capsule version of the drug. While the product patents on Effexor are slated to expire by 2017, the patent on key ingredient venlafaxine expired this year.
"We are yet to take a decision on resubmitting the ANDA," responded Uday Baldota, a spokesperson for Sun Pharma.
Osmotica's generic version of Venlafaxine extended release tablets was approved by US FDA in May 2008 before Sun Pharma could get approval. Following this, Osmotica filed a citizen petition with US FDA directing all subsequent ANDA filers to resubmit their ANDA for proving bio-equivalence to Osmotica's tablet version, and not Wyeth's capsule version.
Though Sun Pharma had challenged the patents on three strengths of Effexor in 37.5 mg, 75 mg and 150 mg, based on an innovative technology for extended release tablets, Wyeth Pharmaceuticals did not sue Sun Pharma for infringing its patent and had issued a ‘covenant not to sue’ (a legal term in which an aggrieved party agrees not to sue the party liable to such action).
US generic drug major Mylan Pharmaceuticals is believed to be the first to file ANDA for this drug on capsule form. Wyeth had also entered into an out-of-court settlement with Teva Pharmaceuticals of the US for the same product in capsule form. However, Wyeth chose to sue other challengers such as India's Lupin Pharmaceuticals, Impax Laboratories, Anchen Pharmaceuticals and Alsa Corporation (a subsidiary of Johnson & Johnson) in the case of Effexor XR capsules.
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