Injunction blocks Dr. Reddy’s generic Allegra D24
NEW YORK A U.S. District Court has granted French drug maker Sanofi-Aventis and Albany Molecular Research an injunction halting the launch of a generic version of one of its drugs made by Dr. Reddy’s Labs, Dr. Reddy’s said.
The U.S. District Court for the District of New Jersey blocked the release of Dr. Reddy’s fexofenadine hydrochloride and pseudoephedrine hydrochloride extended-release tablets in the 180 mg and 240-mg strength, a generic version of Allegra D24, marketed by Sanofi-Aventis and discovered by Albany Molecular Research.
Dr. Reddy’s said it strongly disagreed with the lawsuit and intended to appeal. According to published reports, the Food and Drug Administration had approved Dr. Reddy’s version of the drug following a 30-month stay of approval resulting from a patent infringement lawsuit filed against the company when it tried to seek approval for the generic. The last patents covering Allegra D24 expire in December 2020.
Gilead patent for Ranexa challenged by Lupin
FOSTER CITY, Calif. Indian generic drug maker Lupin is challenging a Gilead Sciences patent for a drug that treats chronic angina, Gilead said.
Gilead said it received a notice that Lupin had filed an approval application with the Food and Drug Administration for a generic version of Ranexa (ranolazine) extended-release tablets. Lupin’s application contained a Paragraph IV certification, a legal assertion under the Hatch-Waxman Act of 1984 that Gilead’s patents covering Ranexa are invalid, unenforceable or won’t be infringed by Lupin’s version.
Under the Hatch-Waxman Act, Gilead has 45 days from the receipt of the letter to file a patent infringement lawsuit against Lupin. Such a suit would prohibit the FDA from approving Lupin’s version of the drug for two and a half years or until the court rules against Gilead. The patents covering Ranexa are set to expire in 2019, according to FDA records.
Taro sales rise in Q1
HAWTHORNE, N.Y. First-quarter sales for Taro Pharmaceutical Industries increased by 5.2% to $89.3 million from $84.9 million in first quarter 2009, the Israeli generic drug maker said Monday.
Profit for the quarter was $10.2 million, compared with $11.1 million in first quarter 2009, including a $3.8 million decrease resulting from foreign exchange expenses related to changes in rates between the U.S. and Canadian dollars.