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
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
producers can't compete against these renegades.
The report helps executives to comprehend the factors that impact the Global generics
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
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.