Drug Pricing and the Law: Regulatory Exclusivities
May 17, 2019
Drug Pricing and the Law: Regulatory Exclusivities
The Food and Drug Administration (FDA) generally must
demonstrate the safety and effectiveness of the follow-on
approve pharmaceutical products, such as drugs and
product; and (2) marketing exclusivity, which precludes
biologics, before they can be marketed in the United States.
FDA from approving any other application for an identical
To obtain approval of a new drug or biologic (i.e., the
or biosimilar product for the same use, even if the applicant
brand-name or reference product), the sponsor must submit
has generated its own data. During a period of data
to FDA data from clinical investigations demonstrating that
exclusivity, a company could theoretically submit a full
the underlying product is safe and effective for its intended
application with its own data for the same pharmaceutical
use. Conversely, a follow-on product, such as a generic
product and use. As a practical matter, however, data
drug or biosimilar, via an abbreviated process by relying
exclusivity and marketing exclusivity may generate the
upon the data generated to support approval of the reference
same result due to the significant investments required to
product. In order to balance interests in competition with
generate the necessary safety and effectiveness data.
the countervailing interest in encouraging innovation,
federal law establishes periods of regulatory exclusivity that
This table describes the types of exclusivities available,
limit FDA’s ability to approve applications to market
their duration, criteria to obtain them, and the impact on
pharmaceutical products under certain circumstances.
FDA’s ability to approve other applications. For more
information, see CRS Report R45666, Drug Pricing and
There are two general categories of regulatory exclusivity:
Intellectual Property Law: A Legal Overview for the 116th
(1) data exclusivity, which precludes applicants from
Congress, coordinated by Kevin J. Hickey.
relying on the reference product’s clinical data to
Table 1.Regulatory Exclusivities for Pharmaceutical Products for Human Use
Type of Exclusivity
Length
Criteria
Effect
Drugs
New Chemical Entity
5 years; may be
Application for drug containing an active
FDA cannot accept an
21 U.S.C.
reduced to 4
ingredient that has not been approved before;
abbreviated application for
§§ 355(c)(3)(E)(ii),
years if
or application for a drug that contains as an
the same active ingredient
abbreviated new
that relies on the data in the
355(j)(5)(F)(ii), 355(u)
active ingredient a single enantiomer (each of a
drug application
pair of molecules that are mirror images of one
reference drug application
(ANDA) contains another) that:
paragraph IV
certification that
(1) is contained in a previously approved racemic
a patent listed for drug (a mixture of two enantiomers in equal
the reference
amounts) but has not otherwise been approved
drug is invalid or
as an active ingredient;
not infringed by
(2) treats a therapeutic category that is different
the generic
from that of the racemic drug or other approved
product
enantiomer of the drug; and
(3) does not rely on data contained in application
for previously approved racemic drug and must
include full reports of new clinical investigations
Other New Product
3 years
Application for a change to an approved drug
FDA cannot approve an
21 U.S.C.
that contains at least one new clinical
application that relies on the
§§ 355(c)(3)(E)(iii) & (iv),
investigation that is “essential to the approval” of
data in the reference drug
the application and is conducted or sponsored by
application for 3 years
355(j)(5)(F)(iii) & (iv)
the applicant
First to File
180 days
First to file an ANDA with a paragraph IV
FDA cannot approve another
Paragraph IV
certification that a patent listed for the reference
ANDA for the same drug
21 U.S.C.
drug is invalid or not infringed by the generic
until 180 days after first
§ 355(j)(5)(B)(iv)
product
commercial marketing of first
filer
https://crsreports.congress.gov
Drug Pricing and the Law: Regulatory Exclusivities
Type of Exclusivity
Length
Criteria
Effect
Competitive Generic
180 days
Designation as competitive generic therapy by
FDA cannot approve an
Therapy
FDA based on finding of “inadequate generic
ANDA for the same
21 U.S.C.
competition” (only one active approved drug);
reference product until 180
§§ 355(j)(5)(B)(v),
no unexpired patents or exclusivities for
days after first commercial
356h(b)
reference product
marketing of the drug, if the
first approved applicant has
commenced commercial
marketing
Biologics
Biologic Reference
4 and 12 years
First licensure of a biological product that is:
FDA cannot accept an
Product
after date of first
not a supplemental application;
abbreviated biologics license
42 U.S.C. § 262(k)(7)(A)
licensure
application referencing the
not a change resulting in a new indication,
& (B)
product for first 4 years;
route of administration, dosing schedule,
dosage form, delivery system, delivery
FDA cannot approve an
device, or strength; and
abbreviated biologics license
application referencing the
not a modification to structure of product
product for 12 years
that does not result in a change in safety,
purity, or potency
Interchangeable
12-42 months,
First interchangeable biologic approved for a
FDA cannot determine
Biologic
depending on
reference product;
another product is
42 U.S.C. § 262(k)(6)
timing of
interchangeable means the product is biosimilar
interchangeable with the
commercial
to the reference product, produces the same
reference product for any
marketing and
clinical result in any given patient, and a patient
condition of use until the
patent litigation
can switch between the interchangeable and
earliest of: (1) 1 year after
(see Effects
reference products over multiple doses without
commercial marketing; (2) 18
column)
altering risk
months after approval if not
sued; or, (3) if sued, 18
months after decision or 42
months after approval
Other Purposes
Pediatric Studies
6 months
FDA requests that applicant conducts pediatric
Extends other exclusivities by
21 U.S.C. § 355a(b) & (c)
studies and such studies are completed
6 months;
42 U.S.C. § 242(m)
delays approval for 6 months
after listed patents expire
Orphan Drug
7 years
Designation by FDA as an orphan drug, which is a FDA cannot approve another
21 U.S.C. § 360cc
drug that treats a disease or condition that
application for the same drug
affects less than 200,000 people in the United
for the same disease or
States, or affects more than 200,000 people in
condition for 7 years, with
the United States but there is no reasonable
limited exceptions
expectation that the cost of developing and
making the drug would be recovered
Qualified Infectious
5 years
Designation by FDA as a qualified infectious
Extends other exclusivities by
Disease Product
disease product (QIDP). QIDP means an
5 years
21 U.S.C. § 355f
antibacterial or antifungal drug intended to treat
serious or life-threatening infections, including
those caused by qualifying or resistant pathogens
Source: CRS.
IF11217
Erin H. Ward, Legislative Attorney
https://crsreports.congress.gov
Drug Pricing and the Law: Regulatory Exclusivities
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https://crsreports.congress.gov | IF11217 · VERSION 1 · NEW