Schering and Sepracor to produce Clarinex-D generics
HYDERABAD, India Dr. Reddy’s has entered into agreements with Schering and Sepracor that will allow it to manufacture and market generic versions of the 12-hour and 24-hour formulations of the prescription antihistamine Clarinex-D, Dr. Reddy’s announced last week.
As part of the agreement, Dr. Reddy’s will get six months’ market co-exclusivity when it starts to market its versions of Clarinex-D(desloratadine) in 2012. Six months later, it will begin marketing its generic version of Clarinex tablets in the 5 mg strength.
The agreements resolve patent infringement suits that Schering and Sepracor filed against Dr. Reddy’s in the United States District Court for the District of New Jersey.
Clarinex products had sales of $362 million in 2007.
KV subsidiary hydromorphone hydrochloride tablets
ROCKVILLE, Md. A subsidiary of KV Pharmaceutical has recalled a lot of hydromorphone hydrochloride 2 mg tablets due to the possibility of oversized tablets, the Food and Drug Administration announced Tuesday.
Ethex Corporation and the FDA have notified healthcare professionals of the recall. The FDA that the oversized pills may lead to improper dosage, thus increasing the risk of adverse side affects associated with the drug, including difficulty breathing, low blood pressure and sedation.
The recalled tablets are round and blue, with a script “E” on one side and a “2” on the other. The recalled lot number is 90219, with an expiration date of March 2010 and the NDC number 58177-0620-04.
The tablets are a generic version of Purdue Pharma?s Dilaudid and used to treat severe pain.
Eli Lilly signs $497 million deal for dirucotide
NEW YORK Eli Lilly & Co. may get some relief from its drying pool of patent-protected drugs.
The Indianapolis drug maker has signed an agreement worth $497 million with biotech firm BioMS Medical Corp. for the drug dirucotide, a treatment for multiple sclerosis.
Expiring patents on Lilly drugs place nearly $10 billion of the company’s sales under threat.