Mumbai, Jun 11 (UNI) Lupin Limited today announced that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Ramipril capsules.
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 USD 920 million for the twelve months ended December 2007, based on IMS Health sales data.
On June 5, in an effort to restrict Lupin's launch, King filed a motion for a Temporary Restraining Order (TRO) and preliminary injunction against Lupin Pharmaceuticals. The hearing occurred on June 10 and King's motion was denied.
Lupin Managing Director Dr Kamal K Sharma said ''We are very excited with the grant of final approval from the FDA as well as the decision from the court''.
Lupin was the first company to successfully challenge the brand and open the market to generic Altace capsules, he said adding the commercial shipments of the product have commenced.
Lupin Pharmaceuticals Inc is the wholly-owned US subsidiary of Mumbai-based Lupin ltd. Its Vice President of Sales and Marketing Bob Hoffman said ''This has been a hard fought battle and reflects Lupin's determination to continue its efforts to bring quality, affordable generic alternatives to our customers.'' UNI GR OBB SM1602