'Authorized generic' is a contentious issue between generic players and pioneer companies. Various generic players have constantly opposed the launch of authorized generics by innovator, which affect sale of First Para IV filer generic player during 180 days generic exclusivity period. The “authorized generic’ launch is the last resort for innovator companies when the generic launch is imminent.
It’s almost 25 years of passage of Hatch-Waxman act which has revolutionised health care reforms in US by facilitating low cost generic version. Hatch-Waxman act stimulated the growth of robust generic drug industry and has balanced interests of pioneer companies and generic players. However, pioneer companies have intelligently devised strategies to thwart generic challenge by exploring loopholes like 'authorized generics' issues.
In the past, the 'authorized generic' launch by innovator has significantly affected the sale forecast of generic players. The 'authorized generic' launch of blockbuster molecules like Gabapentine (Neurontin), Paroxetine (Paxil), Ciprofloxacin (Cipro), Fexofenadine (Allegra), Pantoprazole (Protonix), Nitrofurantoin (Macrobid), and Alendronate Sodium (Fosamax) has significantly affected the sale of First Para IV filer generic player.
Also, generic players have unsuccessfully opposed 'authorized generics' at various forums like in courts and regulatory authority. 'Authorized generic' is like a sword for innovator companies and till date, there is no protective shield for generic players against this sword.
FTC report
In an attempt to review and address this issue, the US Federal Trade Commission (FTC) has issued “Authorized Generics: An Interim Report,” which presents the first set of results from a study conducted to examine the short-term and long-term effects of “authorized generics” on competition in the prescription drug marketplace.
An authorized generic exists when a pharmaceutical manufacturer sells a drug under both a brand-name and generic label. The FTC conducted the study in response to requests from Congress. Issues related to generic drug competition are relevant to current legislative debates and health care reform.
The FTC Interim Report examines the short-term effects of authorized generics during an initial period of generic competition.
Press release of FTC Here
Complete report of FTC Here
Earlier news of IP Pharma Doc on this issue Here
Dear Readers,
I would like to receive your expert comments on this issue
Regards
D.K. Sarwal
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