Federal law and regulations grant a 180-day period of exclusive marketing to the first
generic manufacturer to submit an application for a new
generic drug approval.
Australasia is one of the world's fastest growing
generic pharmaceutical markets with 40 percent annual growth expected over the next five years.
circulated a proposal ("Scientific and Technical Principles for Fixed-Dose Combination Products") that appears to require major clinical trials for approving
generic fixed-dose combinations for HIV, trials not required for similar approvals in the U.
Registration issues are usually well defined, and although the
generic registrant pays its fair share of the cost to defend the registration, the pathway to the defense of molecules is often clear.
And if we are not more efficient in the utilization of more
generic drugs, we won't be able to provide affordable pharmacy benefits.
In addition, the government study also discovered that Canada's
generic drags are 69 per cent more costly than prices charged by major u.
com) that includes names, addresses, and contact data for
generic companies.
Generic producers can't compete against these renegades.
The report helps executives to comprehend the factors that impact the Global
generics market.
There isn't a strong voice out there for
generic drugs,'' said Robert Seidman, chief pharmacy officer for WellPoint.
Brand-name drugs that have a patent don't have an equivalent
generic drug to compete with, so they're usually quite expensive.
Activists from Paris and from Burkina Faso had organized the
generics meeting.
Our report also gives in-depth profiles of the five leading
generic manufacturers: Teva, Sandoz, Mylan, Watson and Ratiopharm.
The authorized
generic launched at a greater discount to the branded drug than the conventional
generic, in 65% of agreements under analysis, reflecting the higher margins available to the authorized
generics company which potentially neither developed, manufactured, or obtained approval to market the drug.
Important factors that could cause or contribute to such differences include risks relating to Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing
generic equivalents, the competition from brand-name companies that are under increased pressure to counter
generic products, or competitors that seek to delay the introduction of
generic product, Teva's ability to generate revenues and profits closely tied to our success in obtaining U.