Generics

INDIANAPOLIS — The U.S. District Court for the District of Delaware has upheld a patent held by Indianapolis-based drug maker Eli Lilly covering a chemotherapy drug, Lilly said Monday.

 

The case concerns a patent covering Alimta (pemetrexed) that expires in July 2016 and generic drug maker Teva Pharmaceutical Industries’ challenge to it.

 

 

ALEXANDRIA, Va. — The Centers for Medicare and Medicaid Services has proposed a rule shortening the traditional 30-day drug cycle for long-term care centers to seven days when brand-name drugs are dispensed, prompting a supportive response from an organization representing independent pharmacies.

 

LAKE FOREST, Ill. Generic injectable drug maker Hospira has launched a version of a chemotherapy drug, the company said Monday.

 

Hospira announced the launch of gemcitabine hydrochloride in 2-g vials, a generic version of Eli Lilly’s Gemzar.

 

 

Gemzar had sales of nearly $750 million in 2009, according to Hospira.

 

WALTHAM, Mass. — William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and paved the way for “The Matrix” movie franchise, once said, “The future is already here—it’s just not evenly distributed.”

He was correct. Emerging technologies, ranging from computers to mobile phones, historically have migrated from the theoretical to the inaccessible to the aristocratic to the indispensable and finally to the mundane.

CHICAGO An investigational drug made by Johnson & Johnson is more effective in reducing the risk of stroke in patients with a trial fibrillation than a widely available generic, the drug maker said Monday.

J&J announced results of the phase-3 “Rocket-AF” trial of rivaroxaban, saying results showed that a once-daily dose of the drug worked better than warfarin, the most commonly used drug for preventing stroke in AF patients. Rivaroxaban also was comparable in terms of safety.

NEW YORK — A ghost from 2008 soon could come back to haunt 2010.

According to published reports, the Food and Drug Administration may be considering adopting tougher standards for certain classes of generic drugs if it determines that some are not equivalent to their branded counterparts.

NEW YORK — Look for a big surge in brand-to-generic drug switches at the pharmacy counter over the next year.

ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.