Biomedical Engineering Reference
In-Depth Information
Table 9.1
Summary of pharmaceutical product life cycle extension strategies and tactics with source literature
Strategy
Protection/exclusivity
Duration
Logic/tactics/how to
Source
FDA review extension
Patent term extension
Normally between
2.5 and 3 years
(max. 5 years)
FDA approval delay related. Apply for
extension once approval for NDA is
granted
FDA (
2003
)
Fighting ANDA “Evergreening”
Patent litigation
Up to 30 months
File more Orange Book patents to trigger
the repeated use of 30-month stay
provision to delay the generic
introduction for many years
FTC (
2002
); Higgins
and Graham (
2009
)
Reformulate active ingredient
Composition claim patent
3 years
Phase development efforts for improve-
ments to patented compounds
Yoshitani (
2007
)
Conducting pediatric studies
Patent supplementary
marketing exclusivity
6 months added to
existing exclusivity
periods
Conducting trials on children
FDA (
1999
,
2009)
Orphan drug act
Marketing exclusivity
Up to 7 years
Gain marketing exclusivity by developing
product variations specifi cally
targeting diseases with <200,000
people in the USA
DHHS (
2001
)
New indications
SNDA marketing
exclusivity
3 years per indication
Expand use to extended exclusivity for
other uses
Glover (
2007
)
Introducing OTC formulas
Trademark/marketing
exclusivity
Indefi nite/up to 3 years
Gain approval for OTC, then build market
through DTC advertising
Brass (
2001
);
Berndt et al. (
2003
)
License manufacturing process
Process claim patents
Life of patents
License process claim patents to generic
manufacturers to capture some value
in the generics market
Common sense
New pill mechanisms
Composition claim patent
Life of patents
Improve convenience or effi cacy through
reformulation
Bhat (
2005
);
Harris (
2002
)
Non-pharmaceutical claims on
chemical
Method of delivery
Life of patents
Develop new dosage forms or introduce
new methods of delivery (capsules
instead of pills)
Bhat (
2005
)
Search WWH ::
Custom Search