Generic drugs development , selection of generic drugs , generic drugs approval process , hatch waxman act and amendment, orange book

1. GENERIC DRUGS
Sumitted by : J.Divija
M.Pharmacy(pharmaceutics)
sree vidhyanikethan collage of pharmacy(MBU)

2. Introduction:
• A generic drug product is essentially identical to the brand name
drug product in terms of active ingredient , dosage form , route
of administration , quality , safety , efficacy , performance
characteristics and therapeutical indication.
• Ex:’ phenytion’ is the generic drug and ‘dilantin’ pharmacological
is the brand name for the same drug
• Brand drugs are the drugs which are protected by the patent
• It is made of the same active ingredient as its innovator drug
• The pharmacological effect of a generic drug is exactly the same
as those of its innovator drug.

3. Selection of generic drugs for manufacture
• The main driving force for the selection of generic drugs product for
manufacture is the estimsated sales volume for the branded product.
• The generic drug manufaturer needs to consider :
• The lead time that is needed to make the product and submission of an
‘Abbreviated new drug application’[ANDA]to the USFDA for approval.
• 180 days exclusivity is given under certain conditions for the generic
manufacturer who is to file first.
• Formlation considerations for generic drugs include :
• The availability of raw materials, chemical purity, polymorphic form.
• particle size of the active pharmaceutical ingredient.

4. Generic drug approval process
• The FDA’s office of generic drugs is responsible for renewing the ANDA and approving the
drugs product marketing.
• The ANDA for generic drug product approval is based on bioequivalence to the brand name
product, appropriate chemistry and manufacturing information and appropriate labelling.
• Generic drug sponsers donot have to perform the non clinical toxicity studiesor expensive
clinical efficacy and safety studies.
• NDA which is submitted to the FDA for market approval of the brand name drug product.
• FDA approved generic drugs must meet the same rigid standards as the innovator drug.
• To obtain FDA approval , a generic drug product must contain same active ingredient as
approved drug product the inactive ingredients may vary.

6. Steps in generic drug product development process :
• Concept development
• System level design
• Detail design
• Testing and refinement
• Production ramp up

7. HATCHWAXMAN ACT AND AMENDMENTS
 It is known ‘as the drug price competition’ and ‘patent
term restoration act’.
 Enacted in 1984.
 Amended the patent laws.
 Amended the federal food, drug and cosmetic act.
 IN 1962 proof of efficacy was made com,pulsory for
marketing approval of new drug.

8. Objectives of the act :
 Reduce the cost associated with approaval of generic drugs
 Allowing the early experimental use
 Compensating the branded drugs manufacturers for the time lost from the patent term
because of the regulatory approval formality
 Motavating the generic drug manufacturers

9. Salient features of the act :
 Patent term extension
 Patent challenges
 Exemption to infringement
 Generic exclusivity
 Prior to the generic drug manufacturer had to do the entire clinical trails

10. Provision of the act :
• Creation of the section 505[j].
• Selection of 505[j] established the ANDA approval process.
• The timing of ANDA approval depends in part on patent protection for the innovator drug.
• On approval of NDA , FDA publishes the patent information of drug in orange book.
• An NDA applicant must submit the following information for each patent -
a . patent number and date on which patent will expire
b . type of patent , drug product , method of use , name of the patent owner must be specified.

11. Hatch waxman trade off :
Benefits for generic manufacturers
• 180 days market exclusivity for first successful challenger to orange book patent.
• Allows generics to challenge orange book patents without risk of damages .
• Safe harbour rule allows generics to perform bioequivalence and other testing to regulatory approval
without risk of patent infringement.

12. ORANGE BOOK
 On approval of NDA , FDA publishes patent information of drug are included in orange book.
 The orange book is composed of 4 parts :
 Approved prescription drug products with the therapeutic equivalence evaluations.
 Approved OTC drug products
 Drug products with approval under section 505 of the FDC act
 Acumulative list of approved drug products that have never been marketed.

13. Objectives :
• This book contains therapeutic equivalence evaluations for approved prescription drug
products
• These evaluations are been prepared to serve as public information
• To review the patterns of access and usage
• To allow discovery of use of unusual privilages
• To allow discovery of repeated attempts to bypass protections
• To supply an additional form of user assurance

14. Loopholes in Hatch waxman act :
 Authorised generics
 30 months stay
 warehouse patent
 Reverse payments
 Citizens petitions

15.  https://www.slideshare.net/SachinG19/generic-drugs-product-development-
176738668
 https://www.slideshare.net/Basantsah2/generic-drug-product-development
 Generic drug product development , solid oral dosage forms , Leon shargel and
Marcel dekkar series , vol . 143
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