DRUGS REPORTS

Drugs Off-Patent Reports
Drugs Off-Patent
Reports
HOW THE CODES WORK
Generic Drug Products generally have two codes namely a PATENT USE Code and
an EXCLUSIVITY code. These two patent protection codes usually expire at quite
different times.
Generally when the New Chemical Entity (NCE) expires the Generic equivalent of
the Brand Leader may be manufactured after appropriate ANDA approval. However
several exclusivity's may be in force (i.e. the 'N' or 'D' codes) such as 'New Dosage',
'New Salt' or 'New Strength' etc. The 'D codes' apply to New Dosing Schedules and
are much less common.
Naturally the package insert of an on-market generic drug will not show a new
indication still protected by an I-code exclusivity. Thus I-code exclusivity's may run for
several years while the generic is being marketed. The same applies for the 'N' and
'D' codes as well.
Drug OFF
Generic Patent
or ON
Name Holder
Patent
Marketer
Patent
Expiry
+
Exclusivity
Expiry
Patent
&
Exclusivity
Earliest
Generic
1999
2000 1
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
More than
one name
may exist
U-Codes
apply here
All other
codes
apply here
DD/MM/YY
In
Millions
of US
Dollars
U-Codes
Apply to this
Patent # and
this Patent
date.
Several
Patents may
exist for each
Generic
The following codes
apply to this
exclusivity date:-
All
I-codes
D-codes
NCE
NDF
NE
NC
NS
NP
ODE
This Date is the
earliest generic
marketing date and
may apply to either
the patent expiry or
a Exclusivity Expiry.
NOTE
In many cases an
OFF-Patent Generic
may have an
ON-Patent
I Code; U Code or N
code
The Codes:-
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength
NCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug Product
NDF = New Dosage Form NC = New Combination 2001 1 USA + EU Sales
D = New Dosing Schedule
U = Code for 'Therapeutic Use' still
under Patent Protection.
I = Code for New Specific
Indication under Exclusivity
Protection.
Drugs Off-Patent Reports 6 Over USD$ 100 million