AVRX » Topics » Orphan Drug Designation and Exclusivity

These excerpts taken from the AVRX 10-K filed Mar 31, 2008.
Orphan Drug Designation and Exclusivity
 
Some jurisdictions, including the United States and the European Union, designate drugs intended for relatively small patient populations as “orphan drugs.” The FDA, for example, grants orphan drug designation to drugs intended to treat rare diseases or conditions that affect fewer than 200,000 individuals in the United States or drugs for which there is no reasonable expectation that the cost of developing and making the drugs available in the United States will be recovered. In the United States, orphan drug designation must be requested before submitting an application for approval of the product.
 
Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. If a product which has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to seven years of marketing exclusivity. During this time, the FDA may not approve another drug application to market the “same drug” for the same indication. The only exception is where the second product is shown to be “clinically superior” to the product with orphan drug exclusivity, as that phrase if defined by the FDA, and if there is an inadequate supply.
 
Orphan
Drug Designation and Exclusivity



 



Some jurisdictions, including the United States and the European
Union, designate drugs intended for relatively small patient
populations as “orphan drugs.” The FDA, for example,
grants orphan drug designation to drugs intended to treat rare
diseases or conditions that affect fewer than 200,000
individuals in the United States or drugs for which there is no
reasonable expectation that the cost of developing and making
the drugs available in the United States will be recovered. In
the United States, orphan drug designation must be requested
before submitting an application for approval of the product.


 



Orphan drug designation does not convey any advantage in, or
shorten the duration of, the regulatory review and approval
process. If a product which has an orphan drug designation
subsequently receives the first FDA approval for the indication
for which it has such designation, the product is entitled to
seven years of marketing exclusivity. During this time, the FDA
may not approve another drug application to market the
“same drug” for the same indication. The only
exception is where the second product is shown to be
“clinically superior” to the product with orphan drug
exclusivity, as that phrase if defined by the FDA, and if there
is an inadequate supply.


 




This excerpt taken from the AVRX 10-K filed Mar 30, 2007.
Orphan Drug Designation and Exclusivity
 
Some jurisdictions, including the United States and the European Union, designate drugs intended for relatively small patient populations as “orphan drugs.” The FDA, for example, grants orphan drug designation to drugs intended to treat rare diseases or conditions that affect fewer than 200,000 individuals in the United States or drugs for which there is no reasonable expectation that the cost of developing and making the drugs available in the United States will be recovered. In the United States, orphan drug designation must be requested before submitting an application for approval of the product.
 
Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. If a product which has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to seven years of marketing exclusivity. During this time, the FDA may not approve another drug application to market the “same drug” for the same indication. The only exception is where the second product is shown to be “clinically superior” to the product with orphan drug exclusivity, as that phrase if defined by the FDA, and if there is an inadequate supply.
 
This excerpt taken from the AVRX 10-K filed Mar 31, 2006.
Orphan Drug Designation and Exclusivity
 
Some jurisdictions, including the United States and the European Union, designate drugs intended for relatively small patient populations as “orphan drugs.” The FDA, for example, grants orphan drug designation to drugs intended to treat rare diseases or conditions that affect fewer than 200,000 individuals in the United States or drugs for which there is no reasonable expectation that the cost of developing and making the drugs available in the United States will be recovered. In the United States, orphan drug designation must be requested before submitting an application for approval of the product.
 
Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. If a product which has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to seven years of marketing exclusivity. During this time, the FDA may not approve another drug application to market the “same drug” for the same indication. The only exception is where the second product is shown to be “clinically superior” to the product with orphan drug exclusivity, as that phrase if defined by the FDA, and if there is an inadequate supply.
 
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