Innovator drugs are the original medications with approved efficacy, safety, and quality, typically protected by a patent for up to 20 years. Generic drugs, made with the same active ingredients, can be marketed after the patent expires and must undergo bioequivalence studies to ensure safety and effectiveness. While there are myths about the inferiority of generics, they are held to the same safety and efficacy standards as innovator drugs, and often come at a lower cost.

1. Generics and Innovators
Prof. Sachin N. Kothawade
Department of Pharmaceutics,
Sitabai Thite College of Pharmacy,
Shirur

2. What Is Innovator Drugs?
An innovator drug is the first drugs created containing its
specific active ingredient to receive approval for use. It is
usually the product for which efficacy, safety and quality
have been fully established. When a new drug is first made,
drug patent usually will be acquired by the founding
company. Most drug patents are protected up to 20 years.
During the patent period, other companies cannot make or
sell the same drug until the patent expires.

3. What Is Generic Drugs?
A generic drug is made of the same active ingredient as
its innovator drug. An active ingredient is the chemical
contained inside a drug that makes it work. In other
words, the pharmacological effect of a generic drug is
exactly the same as those of its innovator counterpart.
Other companies can manufactures the generic drugs
when patent expires.

4. Are innovator drugs and
generic drugs similar?
There are similarities between generic and innovator
drug, such as:
❑ Active ingredient
❑ Strength (dose)
❑ Therapeutic effect
❑ Side effects
❑ How to take

5. Examples of Innovator And
Generic Drugs
Active ingredients Innovator Generic
RanitidineHCL Zantac X’tac
Mefenamic acid Ponstan Mefetab
Piroxicam Feldene Apo-Piroxicam

6. Are generic drugs as safe as
the innovator drugs ?
Drug Control Authority (DCA) in Malaysia, imposes
stringent evaluation for all products include generic
drugs to be listed in Malaysia to ensure quality, safety
and effectiveness. Generic Drugs are required to
undergo bioequivalence (BE) studies to ensure the
therapeutic effect of generic drugs are equivalent (can
be interchanged ) with the innovator drug before drugs
are allowed to be marketed in Malaysia.. Therefore,
registered generic drugs are as safe and effective as
innovator drugs.

7. Myths of Generic Drugs
Some myths that are often associated with generic
drugs:
✓ Generic drugs are not as safe as innovators
✓ Generics drugs are not as effectives as innovator
✓ Generics drugs take longer time to act in the body

8. Myths of Generic Drugs
✓ Generic drugs use the same active ingredients as
innovator drugs and work the same way. So they have
the same risks and benefits as the innovator drugs.
✓ Generic drugs may look different because of certain
inactive ingredients, such as colors and flavorings agents,
may be different. These ingredients do not affect the
safety, effectiveness or performance of the generic drug.
✓ So, there’s no truth in the myths that generic drugs are
inferior in quality as compared to innovator drugs.

9. Generic Drug Issues
➢ Innovator drugs are more expensive because the company who first
manufactures the drug spends large amount of money in research to
develop the new drug which includes clinical trials, marketing and
promotionof the drugs.
➢ Generics drugs are cheaper as their manufactures are not required to
demonstrate their efficacy and safety through clinical trials as these
have also been established by the innovators.
➢ However, generics drugs still needs to conform to same standard of
quality, safety and efficacy required of the innovators. In addition,
when the patent of a drug expired, there will be more company
produce generic drugs which create competition and may reduce the
cost of a drug.

10. R&D overview
Post
marketing
safety
surveillance
Pre
clinical
animal
tests
Clinical
human
studies
Discovery &
synthesis
?? years 1- 3 years 2 - 10 years 2 - 12 years
NCE
marketing
approval
Generic
marketing
approval

11. Global use of generics
⚫ USA: 50%
⚫ Germany: 60%
⚫ UK: 60%
⚫ Australia: 30%
⚫ Malaysia: 40%

12. Innovator Vs Generic
Attribute Innovator Generic
Quality systems ? Prefer
cGMP Yes
⚫Source countryimportant
Yes
⚫Source countryimportant
Test Standards Yes Monograph
Stability Yes Yes
Efficacy Yes Yes
⚫but may not be
interchangeable
Safety Yes Yes
⚫ AE as innovator
⚫superBA potential
Price / value $$$ $
Other –
pkg,appearance, etc
? ?
Regulatory compliance Yes Yes

13. Innovator Vs Generic
⚫ Personal preference
⚫ Price maybe more of concern to some
patients to manage health expenditure
⚫ Look for ‘reliable’ manufacturer
⚫ BE is important for patients switching from
innovator to generic

14. Points to remember
⚫ Not all generic products bad and only innovator good
⚫ Not all generic products good
⚫ BE important especially for products for serious
diseases & narrow safety margins
⚫ Reputable manufacturer important
⚫ Price is important
…… but must be balanced with patient’s care