Generic Drugs and Brand Name Medications
GENERIC
DRUGS
PRODUCT
DEVELOPMENT
GENERIC
DRUG
A drug
product
that
is
comparable
to brand/innovator
drug
in
dosage
form
,
strength
,
route
of
administration
, quality and
performance
characteristics
, and
intended
use. It should
contain
the
same
active
ingredients
as the original
formulation
WHAT
ARE
GENERIC
DRUGS
?
They are
drugs
which
have
the same chemical
composition
as
branded
drugs
are
and sold
under
their
chemical
name .
For
example
paracetamol
, a pain
killer
, is
the
generic
name
for
branded
drugs
like
Crocin
and
Calpol.
The
market
situation
is a
little
different
in
India
than the USA
or
other
developed nations
.
In
USA
,
when
a
new drug
is
launched
only
the
company that
holds the
FDA patent
are
legally
allowed
to
set
the drug
,
thus giving them
market
monopoly.
In
India
however
there
were
no
patent
laws
till
2005
;
which
meant that
anyone
could
replicate
any
drug
in
India without
legal
ramifications
.
This
led
to
the
trend
of
branded
and
generic
drugs
which
has
99.5%
of
the countrys
generic
drug
share
BASIC DIFFERENCE BETWEEN
GENERIC AND BRAND NAME DRUGS
•
Generic drugs are
copies of brand-name drugs that have exactly the same
dosage, intended use, effects, side effects, route of administration, risks, safety,
and strength as the original drug.
In other words, their pharmacological effects
are exactly the same as those of their brand-name counterparts.
•
T
h
e
b
r
a
n
d
n
a
m
e
o
f
a
m
e
d
i
c
a
t
i
o
n
i
s
t
h
e
n
a
m
e
g
i
v
e
n
b
y
t
h
e
c
o
m
p
a
n
y
t
h
a
t
m
a
k
e
s
t
h
e
d
r
u
g
a
n
d
i
s
u
s
u
a
l
l
y
e
a
s
y
t
o
s
a
y
f
o
r
s
a
l
e
s
a
n
d
m
a
r
k
e
t
i
n
g
p
u
r
p
o
s
e
s
.
T
h
e
g
e
n
e
r
i
c
n
a
m
e
,
o
n
t
h
e
o
t
h
e
r
h
a
n
d
,
i
s
t
h
e
n
a
m
e
o
f
t
h
e
a
c
t
i
v
e
i
n
g
r
e
d
i
e
n
t
.
WHEN
GENERIC
DRUG
MARKETED
A
patent
and
exclusivity
after
protection
ends
Patent
owner
waives
its
rights
FDA
requirements
are
met
WHERE
ARE
THEY
AVAILABLE?
Generic drugs
are
sold
everywhere
including our
local
chemist.
To
buy them one simply has
to
ask
for
generic
version
of a
branded
drug though
they
don’t
have
them
for
all
medicines
The department
of
pharmaceuticals
of the
government
is
responsible
for
promoting
generic
drugs but
they
have
not
done
a
very
good
job
After
the
expiry
of the
patent
or
marketing
rights
of the
patent
drug ,
generic
drugs
are
marketed.
They are comparable to brand
drug in
dosage
form
,
strength
,
route
of
administration
, quality and
performance
characteristics
, and
intended
use.
Generic drugs
are
available at affordable
prices
with
maintaining
quality..
These Generic formulations
balance public
interest
as
critical
disease
like
cancer
, AIDS
etc
PRODUCT
DEVELOPMENT
PRODUCT
:
A
product
is
something
sold
by
an
enterprise
to
its
customers.
PRODUCT
DEVELOPMENT
:
Product
development
is the
set
of activities beginning
with the
perception
of a
market
opportunity
and
ending
in the
production
, sale and
delivery
of a
product.
THE
PRODUCT
DEVELOPMENT
PROCESS
A
process
is a
sequences
of
steps
that
transforms
a
set
of
inputs
into
a
set
of
outputs
A product
development
process
is the
sequence
of
steps
or activities that an
enterprise
employs
to
conceive
, design, and
commercialize
a
product.
Some organizations define
and
follow
a precise
and
detailed
product
development
process .
While others may not
even
be able
to
describe
their
processes
A
GENERIC
PRODUCT
DEVELOPMENT
PROCESS
We
will
consider here
a
generic product development
that
can
be
used
in a
market
pull-
situation.
The
input of
the process
is a mission
statement
and the
output
of
the process
is
the
product
launch
MISSION
STATEMENT
:
identifies
the
target
market
for
the
product
,
provides
a basic
functional description
of
the
product
, and specifies
the business goals
of
the
effort
;
results from well
executed
product
planning phase
PRODUCT LAUNCH
:
Occures
when the
product
becomes
available
for
purchase
in
the
market
place
A
GENERIC
-
PRODUCT
DEVELOPMENT
PROCESS
TESTING
AND
REFINEMENT
PRODUCTION
RAMP
-
UP
PRODUCT
LAUNCH
CONCEPT
DEVELOPMENT
&
APPROVAL
Generic drug product manufacturers must formulate a drug product
that will have the same therapeutic efficacy and clinical performance as
their brand-name
counterpart.
Safety, efficacy and therapeutic equivalence
of such products early
compared to the innovator or brand name
drug product for obtaining
marketing approval
The
needs of the
target market
are
identified
,
alternative
product concepts
are
generated
and
evaluated
, and a
single
development
is
selected
for
further
development
A
concept
is the description of the
form
,
function
and
features
of a
product
and is usually
accompanied
by
a
set
of
specifications
, an
analysis
of
competitive products
, and an
economic
justification
of
the
project
.
SYSTEM
–
LEVEL
DESIGN
Includes the
definition
of the
product
architecture
and the
division of the
product
into
sub
-
systems
and
components
The
final
assembly scheme
for
the
production
system
is
usually
defined
during this
phase
The
output of this phase is
usually
geometric
layout
of the
product
, a
functional specification
of each of the
products
subsystems
, and a
preliminary process
flow
diagram
for
the
final
assembly
process
.
REASON BEHIND DEVELOPMENT
Brand drugs are the drugs which are protected by the
patent.
In 2002 about 47%of prescription drug product are generic
versions while 53% innovator product.
Generic products growth is 19% in 1984 and 50% in 2004.
Every year about 4 billions dollars business potential exists
for next 4 years due to patent expiry.
3
DETAIL
DESIGN
Includes
the
complete
specification
of the
geometry
,
materials
, and
tolerance
of all the
unique parts in the
product
and the
identification
of all the
standard
parts
to
be
purchased
from
suppliers.
A
process
plan is
established
and
tooling
is designed
for
each part
to
be
fabricated
within the
production
system
The
output of this phase is the
control
documentation
for
the
product.
TESTING
AND
REFINEMENT
Involves
the
construction
and
evaluation
of
multiple
pre
–
production
versions
of the
product.
Early prototypes
are
usually built with
production
intent
parts
[parts
with
the
same
geometry
and
material properties
as
intended
for
the
production
version
of the
product
will
work
as
designed
and
whether
or not the
product
will
work
as designed and
whether
or not the
product satisfies
the
key
customer
needs
Later
prototypes are
usually
built with
parts
supplied
by
the
intended
production process
but
may
not be assembled using the
intended
final
assembly
process
.
Later
prototypes
are
extensively evaluated
internally
and
are
also
typically
tested
by
customers
in their
own
use
environment
.
The goal
of the
beta
prototypes
is usually
to
answer
questions
about
performance
and
reliability
in
order
to
identify
necessary
changes
for
the
final
product.
PRODUCTION
RAMP
-
UP
Ramp up
is
a
term
used in economics and
business
to
describe
an
increase
in
firm production
ahead of
anticipated
increases
in
product
demand.
Alternatively,
ramp
up
describes the
period
from completed
initial
product development
to
maximum capacity
utilization,
characterized
by
product
and
process
experimentation
and
improvements.
Ramp up in the
first
sense
often occurs when
a
company
strikes
a deal
with
a
distributor,
retailer,
or
producer,
which
will
substantially increase product
demand.
THANK
YOU
Generic drugs are identical copies of brand-name medications in dosage, strength, quality, and intended use. They contain the same active ingredients but are sold under their chemical name. This article explores the basic differences between generic and brand-name drugs, when generic drugs are marketed, where they are available, and the requirements for brand name drug NDA and generic drug ANDA. Learn more about the development and availability of generic drugs compared to branded medications.
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Presentation Transcript
GENERIC DRUGS PRODUCT DEVELOPMENT
GENERIC DRUG A drug product that is comparable to brand/innovator drug in dosage form, strength, route of administration, quality and performance characteristics, and intended use. It should contain the same active ingredients as the original formulation
WHAT ARE GENERIC DRUGS? They are drugs which have the same chemical composition as branded drugs are and sold under their example paracetamol , a painkiller , is the generic name for branded drugs like Crocin and Calpol. The market situation is a little different in India than the USA or other developed nations . In USA , when a new drug is launched only the company that holds the FDA patent are legally allowed to set the drug , thus giving them market monopoly. In India however there were no patent laws till 2005 ; which meant that anyone could replicate any drug in India without legal ramifications . This led to the trend of branded and generic drugs which has 99.5%of the countrysgeneric drug share chemical name . For
BASIC DIFFERENCE BETWEEN GENERIC AND BRAND NAME DRUGS Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts. The brand name of a medication is the name given by the company that makes the drug and is usually easy to say for sales and marketing purposes. The generic name, on the other hand, is the name of the active ingredient.
WHEN GENERICDRUG MARKETED A patent and exclusivity after protection ends Patent owner waives its rights FDA requirements aremet
BRAND NAME DRUG NDA REQUIREMENTS GENERIC DRUGANDA REQUIREMENTS 1. Labelling 1. Labelling 2. Pharma 2. Pharma 3. Chemistry 3. Chemistry 4. Manufacturing 4. Manufacturing 5. Controls 5. Control 6. Microbiology 6. Microbiology 7. Testing 7. Testing 8. Animal studies 8. Bioequivalence 9. Clinical studies 10. Bioavailability
WHERE ARE THEY AVAILABLE? Generic drugs are sold everywhere including our local chemist. Tobuy them one simply has to ask for generic version of a branded drug though they don thave them for all medicines The department of pharmaceuticals of the government is responsible for promoting generic drugs but they have not done a very good job
After the expiry of the patent or marketing rights of the patent drug , generic drugs are marketed. They are comparable to brand drug in dosage form , strength , route of administration , quality and performance characteristics , and intended use. Generic drugs are available at affordable prices with maintaining quality.. These Generic formulations balance public interest as critical disease like cancer , AIDS etc
PRODUCTDEVELOPMENT PRODUCT : A product is something sold by an enterprise to its customers. PRODUCT DEVELOPMENT : Product development is the set of activities beginning with the perception of a market opportunity and ending in the production , sale and delivery of a product.
THE PRODUCT DEVELOPMENT PROCESS A process is a sequences of steps that transforms a set of inputs into a set of outputs A product development process is the sequence of steps or activities that an enterprise employs to conceive, design, and commercialize a product. Some organizations define and follow a precise and detailed product development process . While others may not even be able to describe their processes
A GENERIC PRODUCT DEVELOPMENTPROCESS We will consider here a generic product development that can be used in a market pull- situation. The input of the process is a mission statement and the output of the process is the product MISSION STATEMENT : identifies the target marketfor the product , provides a basic functional description of the product , and specifies the business goals of the effort ; results from well executed product planning phase PRODUCT LAUNCH : Occures when theproduct becomes available for purchase in the market place launch
A GENERIC-PRODUCT DEVELOPMENTPROCESS MISSIONSTATEMENT PRODUCTPLANNING CONCEPT DEVELOPMENT SYSTEM SYSTEMLEVEL DESIGN DETAIL DESIGN TESTINGAND REFINEMENT PRODUCTION RAMP - UP PRODUCT LAUNCH
CONCEPTDEVELOPMENT & APPROVAL Generic drug product manufacturers must formulate a drug product that will have the same therapeutic efficacy and clinical performance as their brand-name counterpart. Safety, efficacy and therapeutic equivalence of such products early compared to the innovator or brand name drug product for obtaining marketing approval The needs of the target market are identified , alternative product concepts are generated and evaluated , and a single development is selected for further development A concept is the description of the form , function and features of a product and is usually accompanied by a set of competitive products , and an economic justification of the project. specifications , an analysis of
SYSTEM LEVELDESIGN Includes the definition of the product architecture and the division of the product into sub-systems and components The final assembly scheme for the production system is usually defined during this phase The output of this phase is usually geometric layout of the product , a functional specification of each of the products subsystems , and a preliminary process flow diagram for the final assembly process.
REASON BEHIND DEVELOPMENT Brand drugs are the drugs which are protected by the patent. In 2002 about 47%of prescription drug product are generic versions while 53% innovator product. Generic products growth is 19% in 1984 and 50% in 2004. Every year about 4 billions dollars business potential exists for next 4 years due to patent expiry. 3
DETAILDESIGN Includes the complete specification of the geometry , materials , and tolerance of all the unique parts in the product and the identification of all the standardparts to be purchased fromsuppliers. A process plan is established and tooling is designed for each part to be fabricated within the production system The output of this phase documentation for the product. is the control
TESTING ANDREFINEMENT Involves the construction and evaluation of multiple pre production versions of the product. Early prototypes are usually built with production intent parts [parts with the same geometry and material properties as intended for the production version of the product will work as designed and whether or not the product will work as designed and whether or not the product satisfies the key customer needs
Later prototypes are usually built with parts supplied by the intended production process but may not be assembled using the intended final assembly process. Later prototypes are extensively evaluated internally and are alsotypically tested by customers in their own use environment. The goal of the beta prototypes is usually to answer questions about performance and reliability in order to identify necessary changes for the finalproduct.
PRODUCTION RAMP -UP Ramp up is a term used in economics and business to describe an increase in firm production ahead of anticipated increases in product demand. Alternatively, ramp up describes the period from completed initial product development to maximum capacity utilization, characterized by product and process experimentation and improvements. Ramp up in the first sense often occurs when a company strikes a deal with a distributor, retailer, or producer, which will substantially increase product demand.
