Title ; patents and Generics
Name; Ansa Tariq
Roll No # 13 Morning
Department: Pharmacy (Pharm D)
Submitted To: Dr Qaiser Iqbal
Subject; Forensic pharmacy
Session; 2016-2021
Date; 23 Aug,2021
UNIVERSITY OF BALOCHISTAN
PATENT DRUGS
Definition:
“ A patent is a type of intellectual property that gives its owner the legal right to
exclude others from making, using, or selling an invention/ drug for a limited period of years, in
exchange for publishing an enabling public disclosure of the invention. In most countries, patent
rights fall under private law and the patent holder must sue someone infringing the patent in
order to enforce his or her rights”
What exactly are patents?
Patents are form of intellectual property IP rights to a creative work.
Temporary protection from others
Patents are mechanism by which an inventor can disclose an invention in exchange for
the right to prevent others from selling that same invention for the term of the patent.
The most common type of patent is with the small molecule drug is called the
composition of matter patent. This type covers the Structure of the molecule as well as its
use.
Patents on a molecule are typically filed during the lead optimization or animal study
preclinical trail phase.
Duration:
In most parts of world, the patents are effective for 20 years from the date the patent is filed.
patents in a molecule are typically filed during the lead optimization or animal study preclinical
trial phase. The time to bring a lead from pre-clinical all the way to approval easily be 10-12
years, the company has an effective patent life remaining of only about 8 years. So, the exclusive
time window for drugs ”20 year” seems very long time, but in practice the window is much
shorter, likely less than 10 years.
What happened when patent expires?
Generic drug makers can begin marketing their own drug formulations of the same
molecule.
Generic companies seek FDA approval through an abbreviated new drug application, the
ANDA.
Bioequivalence tests show that the generic forms behave the same as the original version
and are short and less expensive.
A generic version fills the market, the price and profitability of drug.
The other name of the drug is its international non-proprietary name, INN.
GENERIC DRUGS
Definition:
“A generic drug is a pharmaceutical drug that contains the same chemical substance
as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale
after the patents on the original drugs expire.”
Or
“Product that is comparable to innovator drug product in dose form, strength, route of
administration, quality and efficacy, and intended use, can only be marketed after patent and
exclusivity protection ends.”
Explanations:
The active chemical substance is the same, the medical profile of generics is
believed to be equivalent in performance. A generic drug has the same active pharmaceutical
ingredients (API) as the original, but it may differ in some characteristics such as the
manufacturing process, formulation, excipients, color, taste, and packaging.
Government regulations in the countries in which they are dispensed. They are labeled with the
name of the manufacturer and a generic non-proprietary name such as c The U.S food and drug
administration (FDA) requires generics to be identical to or within an
acceptable bioequivalent range of their brand-name counterparts, with respect
to pharmacokinetic and pharmacodynamic properties. (The FDA's use of the word "identical" is
a Legal interpretation, not literal.)
Biopharmaceuticals, such as monoclonal antibodies, differ biologically from small molecule
drugs. Biosimilar have active pharmaceutical ingredients that are almost identical to the original
product and are typically regulated under an extended set of rules, but they are not the s
In 2014, according to an analysis by the Generic Pharmaceutical Association, generic drugs
accounted for 88 percent of the 4.3 billion prescriptions filled in the United States.
"Branded generics" on the other hand are defined by the FDA and NHS as "products that are (a)
either novel dosage forms of off-patent products produced by a manufacturer that is not the
originator of the molecule, or (b) a molecule copy of an off-patent product with a trade name."
Since the company making branded generics can spend little on research and development, it is
able to spend on marketing alone, thus earning higher profits and driving costs down. For
example, the largest revenues of Ranbaxy Ranbaxy, now owned by sun pharma, came from
branded generics.
Nomenclature:
Generic drug names are constructed using standardized affixes that distinguish drugs
between and within classes and suggest their action.
Economics:
When a pharmaceutical company first markets a drug, it is usually under a patent that,
until it expires, the company can use to exclude competitors by suing them for patent
infringement. Pharmaceutical companies that develop new drugs generally only invest in drug
candidates with strong patent protection as a strategy to recoup their costs of drug
development (including the costs of the drug candidates that fail) and to make a profit. Generics
sold under license from the patent holder are known as authorized generics.
Generic drugs are usually sold for significantly lower prices than their branded
equivalents and at lower profit margins. One reason for this is that competition increases among
producers when a drug is no longer protected by patents. Generic companies incur fewer costs in
creating generic drugs—only the cost of manufacturing, without the costs of drug discovery
and drug development are therefore able to maintain profitability at a lower price.
Generic drug companies may also receive the benefit of the previous marketing efforts of the
brand-name company, including advertising, presentations by drug representatives, and
distribution of free samples.
Regulation:
Most developed nations require generic drug manufacturers to prove that their formulations are
bioequivalent to their brand-name counterparts.
Bioequivalence does not mean generic drugs must be the same as the brand-name product
("pharmaceutical equivalent"). Chemical differences may exist; a different salt or ester may be
used, for instance. Different inactive ingredients mean that the generic may look different from
the originator brand. However, the therapeutic effect of the drug must be the same
("pharmaceutical alternative").
Enacted in 1984, the Drug Price Competition and Patent term Restoration Act informally known
as the Hatch–Waxman Act, standardized procedures for recognition of generic drugs. In 2007,
the FDA launched the Generic Initiative for Value and Efficiency, an effort to modernize and
streamline the generic drug approval process, and to increase the number and variety of generic
products available.
Seeking to demonstrate therapeutic equivalence to a previously approved "reference-listed drug"
and proving that it can manufacture the drug safely and consistently. For an ANDA to be
approved, the FDA requires that the 90% confidence interval of the geometric mean
test/reference ratios for the total drug exposure (represented by the area under the curve or AUC)
and the maximum plasma concentration (Cmax) should fall within limits of 80–125%. (This
range is part of a statistical calculation and does not mean that generic drugs are allowed to differ
from their brand-name counterparts by up to 25 percent.) The FDA evaluated 2,070 studies
conducted between 1996 and 2007 that compared the absorption of brand-name and generic
drugs into a person's body. The average difference in absorption between the generic and the
brand-name drug was 3.5 percent, comparable to the difference between two batches of a brand-
name drug. Non-innovator versions of biologic drugs, or biosimilars, require clinical trials
for immunogenicity in addition to tests establishing bioequivalence. These products cannot be
entirely identical because of batch-to-batch variability and their biological nature, and they are
subject to extra rules.
Generic Drugs Research
When an application is approved, the FDA adds the generic drug to its Approved drug product
with therapeutic equivalence evaluations list and annotates the list to show the equivalence
between the reference-listed drug and the generic. The FDA also recognizes drugs that use the
same ingredients with different bioavailability and divides them into therapeutic equivalence
groups. For example, as of 2006, diltiazem hydrochloride had four equivalence groups, all using
the same active ingredient, but considered equivalent only within each group.
In order to start selling a drug promptly after the patent on innovator drug expires, a generic
company has to file its ANDA well before the patent expires. This puts the generic company at
risk of being sued for patent infringement, since the act of filing the ANDA is considered
"constructive infringement" of the patent. In order to incentivize generic companies to take that
risk the Hatch-Waxman act granted a 180-day administrative exclusivity period to generic drug
manufacturers who are the first to file an ANDA
MULTIPLE CHOICE QUESTIONS (MCQS)
1) A type of intellectual property that gives its owner the legal right to exclude others from
making, using, or selling an invention/ drug for a limited period of years.
a) Generic
b) Patents
c) Chemicals
d) None
2) Generic companies seek FDA approval through:
a) ANDA
b) DRAP
c) Both a and b
d) None of above
3) Generics sold under license from the patent holder are known as:
a) Illegal generics
b) Unauthorized generic
c) Authorized generics
d) None
4) patents in a molecule are typically filed during the lead optimization or:
a) preclinical trial phase
b) study on animals
c) study on human
d) both a and b
5) Most developed nations require______ manufacturers to prove that their formulations are
bioequivalent to their brand-name counterparts:
a) Brand drug
b) Patents
c) Generic drug
d) All of them
6) "Branded generics" on the other hand are defined by the:
a) NHS
b) FDA
c) NHS and FDA
d) None of them
7) Patents are form of :
a) intellectual property
b) Chemical property
c) Physical property
d) All of them
8) IP stands for:
a) International practices
b) Intellectual properties
c) Both a and b
d) None
9) In most parts of world, the patents are effective for the years from the date the patent is
filed.
a) 8years
b) 12 years
c) 20years
d) 18 years
10) A generic drug is a pharmaceutical drug that contains the same:
a) Pharmaceutical ingredients
b) Excipients’
c) Physical properties
d) All above
11) INN stands for:
a) International non property name
b) International nomenclatures
c) International non-proprietary name
d) None
12) API stands for:
a) Abbreviated pharmaceutical ingredients
b) Active pharmaceutical ingredients
c) Active pharmaceutical industries
d) All of above
13) Which drugs are cheaper:
a) Branded drugs
b) Patents
c) Generics
d) None
14) ___________ are mechanism by which an inventor can disclose an invention in exchange
for the right to prevent others from selling that same invention.
a) Generic
b) Patents
c) Both a and b
d) None
15) The FDA also recognizes drugs that use the same ingredients with different
bioavailability and divides them into:
a) Pharmaceutical equivalence groups
b) Pharmacological equivalence group
c) therapeutic equivalence groups
d) None of them
16) ________does not mean generic drugs must be the same as the brand-name product:
a) Bioequivalences
b) Biotransformation
c) Bioavailability
d) All of them
17) ANDA stands for:
a) Applicable New Drug application
b) Applicable New Drug Administration
c) Abbreviated New Drug Application
d) Abbreviated New Drug Administration,
18) The Drug Price Competition and Patent term Restoration Act informally known as:
a) Hatch–Waxman Act,
b) Waltman Act
c) Hatch-wax Act
d) None of above
19) Generic drugs are usually sold for significantly lower prices than their:
a) Brands
b) Patents
c) Both a and b
d) None of them
20) Patents are_______:
a) Creative work
b) Invention
c) Both a and b
d) None of above
Answers
1. b
2. a
3. c
4. d
5. c
6. c
7. a
8. b
9. c
10. a
11. c
12. b
13. c
14. b
15. a
16. a
17. c
18. a
19. c
20. c
