The Drug Price Competition and Patent Term Restoration Act of 1984, usually referred to as the Hatch-Waxman Act, was designed to promote generics but at the same time giving financial incentive for research and development to the innovator companies. It was changed so many times in so many manner which made very dramatic impact on the pharma industry in US.
Earlier multiple 30 month stay was allowed on filing ANDA with subsequent P IV certification due to new listing of patent in the orange book for the same product but after MMA, it is not allowed to get multiple 30 month stay.
Recently in a case FDA has allowed 30 month stay to the generics with explanation. To get full details please click here.
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