This does not make any sense to me. It seems to fit into the standard template of blaming the big pharmaceutical companies. Generic drugs can be marketed once the original patent for the proprietary drug expires. A pharmaceutical company gets exclusive rights to a particular drug for a given period of time, and generally prices them high to cover the developmental costs. Once the patent expires, any company can produce a corresponding generic drug. These companies do not have the development costs to recoup for this drug, so all they have are the basic manufacturing costs. It should be possible to make just as much money producing the generic drug as the original company did when it had exclusive rights to the drug. If the drug is popular, it seems to me, there would be plenty of incentive for some drug company to produce the drug - all other things being equal. At least that's how it seems to me. I welcome any further illumination on this from FReepers who may have specific knowledge on the subject. The original company can make changes to the drug and keep exclusivity that way.
3.How long is exclusivity granted for?
It depends on what type of exclusivity is granted.
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)
See 21 C.F.R. 314.108 New Drug Product Exclusivity.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm