Basically, there are two types of drug products: (1) new drug products
(NDA) and (2) generic drug products (ANDA). New drug product
development is required to go through through a tedious process, which is
divided into three phases. When there is only "one" phase for the generic
product development. However, it doesn't mean that ANDA is earlier than
NDA. The formulation and process developement for ANDA product can
be MUCH MORE difficult to develop, if the formulator is developing a bio-
equivalent and non-infringing products (paragraph iv). A summary for how
drug product development is outlined as below:
NEW DRUG PRODUCT (NDA)
After a drug company identifies a potential drug candidate, it files an
Investigational New Drug Application (IND). If the IND is approved by the
FDA, the drug company can begin the first phase of development.

The IND consists of three phases: Phase 1, Phase 2 and Phase 3.

In Phase 1, the company first designs a "vehicle" to the drug candidate
and conducts clinical trials using healthy subjects to determine this "drug
product's" basic properties, such as ithe extent of drug absorption, drug
absorption rate and its safety profile in humans. Typically, this stage lasts
for one to two years.

At the beginning of
Phase 2, the drug company conducts a long-term,
small-scale toxicology study (e.g. nine months) for the drug product using
animal subjects. If the drug company demonstrates that its product is safe
to use. The company will initial a long-term, small-scale clinical study to
assess the product's efficacy and safety in hamans.  Drug company also
determines the optimal dosage levels in this stage. At the end of Phase 2,
the drug company will meets with FDA agents to discuss the development
process, test results and the protocols for Phase III.

Phase 3 is usually the most extensive and most expensive part of the drug
product development.  Large-scale testings for safety and efficacy are
conducted in multiple centers. The testings may take years to complete. It
usually involves a few hundred to a few thousand patients. The
information obtained will be used to decide if the drug satisfies its "benefit-
risk relationship".

Once Phase III is complete, the drug company files an New Drug
Application (NDA). The NDA describes the manufacturing process and
composition of the drug product, it also provides evidence of its safety and
effectiveness to FDA.  If the FDA usually takes one to two years to review
and approve the NDA. During the NDA stage, the FDA consults advisory
committees made of experts to abain advices on drug safety, effectiveness
and labeling. Once FDA approves the drug product, the company can
market the drug product with FDA regulated labeling.

GENERIC DRUG PRODUCT (ANDA)

Regulatory Affairs

A generic drug product is identical, or bioequivalent to a brand-name
drug product in dosage form, safety, strength, route of administration,
quality, performance characteristics and intended use.  Although generic
drugs are chemically identical to their branded counterparts, they are
typically sold at substantial discounts from the branded price. It is because
generic manufacturers donÂ’t have the investment costs of the developer
of a new drug. New drug is developed under patent protection. The patent
protects the investment including research, development, marketing, and
promotion by giving the company the sole right to sell the drug while it is in
effect. As patents near expiration, manufacturers can apply to the FDA to
sell generic versions for the original drug product. Because those
manufacturers don' have the same development costs, they can sell their
product at substantial discounts.

Drug companies must submit an abbreviated new drug application
(ANDA) for approval to market a generic drug product.  The Drug Price
Competition and Patent Term Restoration Act of 1984, more commonly
known as the Hatch-Waxman Act, made ANDAs possible by creating a
compromise in the drug industry. Generic drug companies gained greater
access to the market for prescription drugs, and innovator companies
gained restoration of patent life of their products lost during FDA's
approval process.

Under the Hatch-Waxman Act, a company can also seek approval from
FDA to market a generic drug product before the expiration of a patent
relating to the brand name drug upon which the generic is based.  The
first company to submit an Abbreviated New Drug Application (ANDA) with
the FDA has the exclusive right to market the generic drug for 180 days.

Generic Drug Product Development Process

Generic drug product development typically begins by identifying
potential market opportunities. Factors such as market size, patent
expiration date(s), market exclusivity, source of raw materials can affect
the whole generic drug product development process. Once the generic
drug manufacturer select a candidate, the generic drug manufacturer
begins the development process.

The ANDA sponsor's first task is to identify a reliable source of the active
pharmaceutical ingredient (API or the drug) that can meet established
standards of identity, strength, quality, and purity.  Then the ANDA
sponsor will select the inactive ingredients for the formulation based on
compatibility and patents on the innovator's formulation.

After the ANDA sponsor developed the prototype formulation, he will
conduct small-scale bio-equivalence studies (6-8 subjects)to test the
product performance. The ANDA sponsor manufactures the test products
under current good manufacturing practice (cGMP). cGMP represents the
minimum regulatory standards that address every aspect of drug
development, testing, materials, equipment, manufacturing, record
keeping, documentation practices, facilities, and personnel.

If the data for the small-scale study is promising, the ANDA sponsor
manufactures a full bio-batch (100,000 units) for full bioequivalence
studies (> 24 subjects).  For controlled release products and certain types
of products, the ANDA sponsor also needs to run food effect
bioequivalence study.

After the product demonstrates for being bio-equivalent to the innovator
product and it is stable under accelerated conditions (elevated
temperature and humidity) for 3 months, the ANDA sponsor can file an
ANDA to the Office of Generic Drugs (OGD) for the product.  And, the
generic applicant must: 1) certify in its ANDA that the patent in question is
invalid or is not infringed by the generic product (known as "paragraph IV
certification"); and 2) notify the patent holder of the submission of the
ANDA.  As that certification is later sent to the brand company - which, by
filing a patent infringement suit against us, automatically prevents the
FDA's approval of our product for up to 30 months. ANDA sponsor must
then defend itself against the inevitable patent litigation that will be
initiated by the brand company. The total duration from development to
marketing of a product is typical from 4 to 7 years. Though the generic
drug product development process is tedious, the profit can be huge.


                                       
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