Lupin requests court approval to proceed with generic sales of rampril

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Lupin Pharmaceuticals, a wholly owned subsidiary of the Mumbai, India-based Lupin Ltd., has asked the U.S. District Court for the Eastern District of Virginia to declare that its generic ramipril does not infringe on a patent covering King Pharmaceuticals’ branded blood pressure drug Altace.

The FDA tentatively approved Lupin’s abbreviated new drug application (ANDA) for generic Altace (ramipril) capsules May 12, less than a week after the U.S. Patent and Trademark Office assigned a patent covering the drug to Sanofi-Aventis Deutschland, which has licensed it to King. The current patent expires in 2020.

In its complaint, Lupin called King and Sanofi “extremely litigious,” adding it has a “reasonable apprehension” that it will face a suit for alleged infringement on the patent.

The Baltimore-based pharmaceutical company has asked the federal court to declare that the manufacture and sale of ramipril capsules will not infringe on the patent, and also has asked that the patent be declared invalid.

Lupin Pharmaceuticals first filed an ANDA for generic Altace (ramipril) in March 2005, prompting a lawsuit from Sanofi-Aventis Deutschland and King in the U.S. District Court for the Eastern District of Virginia, according to FDA News. At that time, the court found the patent valid and infringed on by Lupin’s ANDA.

Lupin appealed the decision, and the U.S. Court of Appeals for the Federal Circuit reversed the ruling and found King’s ’722 patent invalid due to “obviousness” in September 2007.

Altace had sales of $80 million during the first quarter of the year, compared with $157 million during the same quarter of 2007.