Patent and Generic Pharmaceutical Ethics When a new drug is developed, the pharmaceutical company is initially granted a patent for around 20 years to exclusively sell the drug under a brand name. Once the patent expires, generic drug companies can produce versions of the drug. Generics must be proven to be equivalent to the brand version in dosage, safety, and performance to gain FDA approval. This increased competition brings drug prices down substantially, improving access and affordability for patients.

1. Patent and Generic
Pharmaceutical Ethics

2.  “A patent is a property right to a product”.
 “Patents are a property right granted by the United
States Patent and Trademark Office anytime during
the development of a drug and can encompass a wide
range of claims”.
 In the case of pharmaceutical companies, it is usually
in the form of a chemical formula that may not be
duplicated by any rival company.
Patent

3.  When a pharmaceutical company first develops a new
drug to be used for a disease condition, it is initially
sold under a brand name by which the clinicians can
prescribe the drug for use by patients. The drug is
covered under patent protection, which means that
only the pharmaceutical company that holds the
patent is allowed to manufacture, market the drug
and eventually make profit from it.
Explanation

4.  The drug patent is awarded for around twenty years
in the United States. The lifetime of the patent varies
between countries and also between drugs.
 Once the patent has expired, the drug can be
manufactured and sold by other companies. At this
point, the drug is referred to as a generic drug.

5.  “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”.
 “A generic drug is a medication created to be the
same as an existing approved brand-name drug in
dosage form, safety, strength, route of
administration, quality, and performance
characteristics”.
Generic

6.  A generic medicine works in the same way and
provides the same clinical benefit as its brand-name
version.
 Generic medicines tend to cost less than their brand-
name counterparts.
 When multiple generic companies market a single
approved product, market competition typically
results in prices about 85% less than the brand-name.

7.  After patent & exclusivity protection ends, or
 patent owner waives its rights, and
 FDA requirements are met
Generic drugs must meet high standards to receive
FDA approval
The abbreviated new drug application (ANDA)
submitted by drug companies must show the generic
medicine is the same as the brand-name version in the
following ways:
 The active ingredient in the generic medicine is the
same as in the brand-name drug/innovator drug.
When can a Generic Drug be Marketed?

8.  The generic medicine has the same strength, use
indications, form (such as a tablet or an injectable),
and route of administration (such as oral or topical).
 The inactive ingredients of the generic medicine are
acceptable.
 The generic medicine is manufactured under the
same strict standards as the brand-name medicine.
 The container in which the medicine will be shipped
and sold is appropriate, and the label is the same as
the brand-name medicine's label.

9.  “Quack means a pretender providing health services
without having registration of Medical and Dental
Council, Council of Tibb, Council for Homeopathy and
Nursing Council.”
Quack

10.  https://www.mckendree.edu/academics/scholars/issu
e11/bodem.htm#:~:text=What%20is%20a%20patent%3F,
time%20the%20patent%20is%20issued.
 https://www.fda.gov/drugs/development-approval-
process-drugs/frequently-asked-questions-patents-
and-exclusivity
 https://www.news-medical.net/health/Drug-Patents-
and-Generics.aspx
 https://www.fda.gov/drugs/generic-drugs/generic-
drug-facts
References