Intellipharmaceutics files new drug application for generic Protonix
TORONTO Intellipharmaceutics has filed an abbreviated new drug application for a generic drug designed to treat gastrointestinal issues, the drug maker said.
Intellipharmaceutics said its pantoprazole sodium delayed-release tablets — a generic version of Protonix — inhibits gastric acid secretion and is prescribed for the short-term treatment of such conditions as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.
Sales of pantoprazole sodium delayed-release tablets in the United States were approximately $1.8 billion in 2009.
“I am extremely pleased with the progress we continue to make with the advancement of our product pipeline,” said Isa Odidi, Intellipharmaceutics CEO. “Protonix is the second ANDA we have filed with the FDA this year and, together with Focalin XR and Effexor XR, it represents another potential source of future revenue from our company’s ANDA pipeline.”
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.