US Food and Drug Administration (FDA) has granted final approval for Mumbai based Lupin’s Abbreviated New Drug Application (ANDA) for ramipril capsules, 1.25 mg. 2.5 mg, 5 mg and 10 mg.
Lupin Pharmaceuticals Inc, is the wholly owned US subsidiary of Mumbai, based Lupin Limited, a leading Indian pharmaceutical company. Lupin Ltd develops, manufactures and markets a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world.
Lupin's ramipril capsules are the AB-rated generic equivalent of King Pharmaceutical's Altace capsules, indicated for the treatment of hypertension. The brand product had annual sales of approximately $920 million for the twelve months ended December 2007, based on IMS Health sales data.
On June 5, 2008, in an effort to restrict Lupin's launch, King filed a motion for a temporary restraining order (TRO) and preliminary injunction against Lupin Pharmaceuticals, Inc. The hearing occurred June 10, 2008 and King's motion was denied. Lupin was the first company to successfully challenge the brand and open the market to generic Altace capsules. Because Lupin successfully challenged the patent and the TRO, it is not held back by the citizen's petition holding up other generics, whose timing of entry remains uncertain.