Sun Pharmaceutical Industries and Lupin Ltd will soon add another generic drug each to their US product basket. The companies recieved approvals from the US drug regulator (USFDA) to market generic equivalent of Pfizer’s Dilantin Kapseals and Abbot’s Mavik respectively.
While the final USFDA approval to market Extended Phenytoin Sodium Capsules, USP 100mg (Phenytoin ER) will help Sun Pharma introduce its bio-equivalent soon, Lupin will have to wait for the patent expiry of Mavik in June 2007 and a final nod from USFDA to market its product.
Extended Phenytoin Sodium Capsules, an anticonvulsant drug useful in the treatment of seizures related to epilepsy and neurosurgery, is a $170 million market in the US and is largely shared between the innovator Pfizer and generic major Mylan. Sun Pharma is to market its product through its US subsidiary Caraco Pharmaceutical Laboratories.
Lupin’s Trandolapril Tablets will be the AB-rated generic equivalent of Abbott’s Mavik and enjoys annual product sales worth $ 53 million in the US.
The tentative approval has come for the Company’s Abbreviated New Drug Application (ANDA) for Trandolapril Tablets, 1mg, 2mg and 4mg. Trandolapril is indicated for the treatment of hypertension.
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