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| US
medicare bill |
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| Faster
entry for generics |
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| Gina S.
Krishnan |
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The US passed the Medicare
Bill on 8 December. Now, the US government
will offer 40 million Medicare recipients
federal help in paying for prescription drugs.
The other gainers are Indian generic pharma
companies. This means faster entry for generics
into the US through the current Medicare Bill,
better known as the Medicare Prescription
Drug and Modernization Act of 2003. Under
this, a drug-patent holder who sues for patent
infringement would be able to delay the approval
of a generic once, for 30 months. Now, they
can get multiple 30-month stays to delay approval
of generics. It also has a provision that
would allow generic companies to force the
issue in court if the brand company does not
sue for patent infringement within 45 days.
So generics can reach the market faster. It
will enable multiple generic companies to
qualify for 180-days exclusive time on the
market if all filed their applications on
the same day.
Says Indian Pharmaceutical Alliance, secretary
general, D.G. Shah: "The Indian generic
companies will benefit tremendously." |
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