“A drug product that is comparable to a brand/reference listed

drug product in dosage form, strength, route of

administration, quality and performance characteristics, and
intended use”
It termed "abbreviated" because they generally not
required to include preclinical (animal) and clinical (human)
data to establish safety and effectiveness.
Basic Generic Drug Requirements are:--
• Same active ingredient(s)
• Same route of administration
• Same dosage form
• Same strength
• Same conditions of use
• Inactive ingredients already approved in a similar NDA
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• To reduce the price of the drug.

• To reduce the time development.

• Increase the bioavailability of the drug in

comparison to reference list drug.

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NDA Requirement ANDA Requirement

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A generic drug is considered to be bioequivalent to the
brand name drug if:
 The rate and extent of absorption do not show a

significant difference from listed drug, or

 The extent of absorption does not show a significant

difference and any difference in rate is intentional or not

medically significant

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 Types of ANDA Filing
 While filing an ANDA, the generic company has to
choose one of the following four options
 (referred to as paras):
 Para 1: The drug has not been patented.
 Para 2: The patent for the drug has already expired.
 Para 3: The patent for the product exists but the generic
company wants to enter the markets after the date of
patent expiry passes.
 Para 4: Patent is not infringed upon or is invalid.

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 In case of Para 1 and Para 2 filing, once the application is deemed
complete, it is simply processed for approval. In case of Para 3 the
application is processed for approval, however its approval status
depends upon the products patent expiry.
 Apparently Para 4 filings are the most lucrative, tedious, time
consuming and expensive of the above.
 In a Para 3 filing the company acknowledges the patent of the
approved drug and intends to enter the market after the patent for
the approved product expires and there exists a scenario of falling
prices for the drug,
 whereas in Para 4 filing the company claims that the generic
product of the company does not infringe upon the existing patent
or the patent of the branded product is invalid and the company
strives to win an exclusivity of 180 days during which the margins
for the product are very high.

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 Awarded to first ANDA holder to file a complete
application with patent challenge

 Protection
from other generic competition – blocks
approval of subsequent ANDAs

 Protection triggered by:

First commercial marketing
Forfeiture provisions
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 ANDA
NDA

Applicable for new drug Applicable for generic drug

Take longer time ( 15-20 Compare to NDA less time
years) taken (2-5 years)
More expenditure of money Comparatively less
Cost of drugs are more Cost of drugs are less
Nonclinical studies and clinical Bio equivalence
investigations are essential

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