generic drug development and hatch waxman act and amendment

1. GENERIC DRUG PRODUCT
DEVELOPMENT INTRODUCTION AND
HATCH-WAXMAN ACT & AMENDMENT
PRESENTED BY GUIDED BY
PRIYANKA GOSWAMI Dr. SATYENDRA DEKA
M.PHARM ASSOCIATE PROFESSOR
DEPARTMENT OF PHARMACY DEPARTMENT OF PHARMACY
ASSAM DOWN TOWN UNIVERSITY ASSAM DOWN TOWN UNIVERSITY

2. GENERIC DRUG
• Generic drug are the product that is comparable to brand drug in form of
dosage, strength, route of administration, quality and performance
characteristic and intended use. Generic drug contain the same active
ingredients as the original formulation.
• After the expiry of the patent or marketing rights of the patent drug,
generic drugs are marketed

3. PRODUCT DEVELOPMENT
 Product :
A product is something sold by an enterprise to its customers.
 Product Development :
It is the creation of product with different or new
characteristic that offer additional or new benefits to the customers. It
may involve modification of its existing product or presentation or
formulation of entirely new product that satisfies the customer wants.

4. THE PRODUCT DEVELOPMENT
PROCESS
 A process is a sequence 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 design, and commercialize
a product.

5. A GENERIC PRODUCT
DEVELOPMENT PROCESS
The input to the process 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 a well-executed product planning phase (mission
statement) and the output of the process Occurs when the product becomes
available for purchase in the market place (product launch).

6. A GENERIC PRODUCT
DEVELOPMENT PROCESS
Concept
Development
System-Level
Design
Detail
Design
Testing and
Refinement
Production
Ramp-Up
Product
Launch
Mission
Statement
Product
Planning

7. CONCEPT DEVELOPMENT
o The target needs of market are identified, alternative product
concepts are generated and evaluated, and a single or more concepts
are selected for further development.
o A concept is a 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.

8. SYSTEM-LEVEL DESIGN
o Includes the definition of the product architecture and the division
of the product into subsystems and components.
o The final assembly scheme for the production system is usually
defined during this phase.
o The output of this phase is usually a geometric layout of the
product, a functional specification of each of the product’s
subsystems, and a preliminary process flow diagram for the final
assembly process.

9. DETAIL DESIGN
o Includes the complete specification of the geometry, materials, and
tolerances of all the unique parts in the product and the
identification of all the standard parts to be purchased from
suppliers.
o A process plan is established and tooling is designed for each part
to be fabricated within the production system.
o The output of this phase is the control documentation for the
product.

10. TESTING AND REFINEMENT
o Involves the construction and evaluation of multiple pre-production
versions of the product.
o 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 but not necessarily fabricated with
the actual process to be used in production).
o Early prototypes are tested to determine whether or not the product
will work as designed and whether or not the product satisfies the key
customer needs.

11. PRODUCTION RAMP-UP
o The purpose is to train the work force and to work out any
remaining problems in the production process.
o The artifacts produced during production ramp-up are sometimes
supplied to preferred customers and are carefully evaluated to
identify any remaining flaws.
o The transition from production ramp-up to ongoing production is
usually gradual and continuous.

12. o Later prototypes are usually built with parts supplied by the
intended production process but may not be assembled using the
intended final assembly process.
o Later prototypes are extensively evaluated internally and are also
typically tested by customers in their own use environment.
PRODUCTION RAMP-UP

13. HACTH-WAXMAN ACT AND
AMMENDMENT
INTRODUCTION
• Also 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
• Before 1962- new drug approved based on safety alone
• 1962- Proof of efficacy made compulsory for marketing approval of a
new drug (Kefauver-Harris Amendments)

14. INTRODUCTION
• New drugs manufacturers were required to conduct clinical trials on a
limited number of human individuals so as to determine the efficacy and
safety of the new drugs and submit the results of the same to the USFDA
along with their New Drug Application (NDA).
• Generic manufacturers may file an abbreviated New Drug Application
(ANDA) that incorporates the safety/effectiveness data submitted by
original pioneer drug manufacturer and adds only bioequivalence studies.
Generic applicant asserts non-infringement or invalidity of patents

15. OBJECTIVE
• Reducing the cost associated with the approval of a generic drug
• Allowing Early-Experimental-Use
• Compensating the branded drugs manufacturers for the time lost
from the patent term because of the regulatory approval formality.

16. PROVISIONS OF THE ACT
• Creation of section 505(j)
• Section 505(j) established the ANDA approval process
• The timing of an ANDA approval depends in part on patent protections for
the innovator drug
• NDA must include any patent that claims the "drug" or a "method of using
drug" for which a claim of patent infringement could reasonably be asserted
• On approval of NDA, FDA publishes patent information for drug in Orange
Book (“Approved Drug Products with Therapeutic Equivalence Evaluations”)

17. PROVISIONS OF THE ACT
Four Types of Patent Certifications
 That patent information on the drug has not been filed i.e. no patent
information appears in the orange book. (Paragraph I)
 That the patent has already expired. (Paragraph II)
 The date on which the patent will expire. (Paragraph III)
 That the patent is invalid or will not be infringed by the manufacture, use
or sale of the drug for which the ANDA is submitted. (Paragraph IV)

18. PROVISIONS OF THE ACT
ORANGE BOOK
 FDA publishes patent information on approved drug products in the
Orange Book
 An NDA applicant must submit the following information for each
patent:
 Patent no and date on which the patent will expire
 Type of patent, i.e. drug, drug product, or method of use
 Name of patent owner
 The name of an agent of the patent owner or applicant
 Brand drugs listed for generics to compare with their proposed
products

19. PARA IV- PATENT CHALLENGE