Federal Orphan Drug Credit

Orphan Drug Credit
Form 8820 (Rev. September 2018)
8820

Form
(Rev. September 2018)
Department of the Treasury
Internal Revenue Service

Orphan Drug Credit
▶

OMB No. 1545-1505

Go to www.irs.gov/Form8820 for the latest information.
▶ Attach to your tax return.

Attachment
Sequence No. 103
Identifying number

Name(s) shown on return

Part I

Current Year Credit

1

Qualified clinical testing expenses paid or incurred during the tax year (see instructions) .

.

1

2a

Are you electing the reduced credit under section 280C? ▶

If “Yes,” multiply line 1 by 19.75% (0.1975). If “No,” multiply line 1 by 25% (0.25) and see the
instructions for the statement that must be attached. Members of controlled groups or businesses
under common control, see instructions for the statement that must be attached . . . . . .

2a

b Enter the portion of the credit from Form 8932, line 2, that is attributable to wages that were also
used to figure the credit on line 2a above . . . . . . . . . . . . . . . . . . .

2b

c

Yes

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No

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2c

3

Orphan drug credit from partnerships, S corporations, estates, or trusts .

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3

4

Add lines 2c and 3. Estates and trusts, go to line 5. Partnerships and S corporations, report this
amount on Schedule K. All others, report this amount on Form 3800, Part III, line 1h . . . . .

4

5

Amount allocated to the beneficiaries of the estate or trust (see instructions) .

.

5

6

Estates and trusts. Subtract line 5 from line 4. Report this amount on Form 3800, Part III, line 1h .

6

Subtract line 2b from line 2a. If zero or less, enter -0-

For Paperwork Reduction Act Notice, see instructions.

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Cat. No. 11208S

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Form 8820 (Rev. 9-2018)

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Form 8820 (Rev. 9-2018)

Part II
(a)

Orphan Drug Information (see instructions)
(b)
Name of orphan drug

(c)
Designation application number

(d)
Date drug designated
(mm/dd/yyyy)

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Form 8820 (Rev. 9-2018)

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Form 8820 (Rev. 9-2018)

General Instructions
Section references are to the Internal
Revenue Code unless otherwise
noted.
Future developments. For the latest
information about developments
related to Form 8820 and its
instructions, such as legislation
enacted after this form and
instructions were published, go to
www.irs.gov/Form8820.
What’s New. For tax years
beginning after 2017, the credit rate
for the orphan drug credit has been
reduced to 25% and there is an
election for a reduced credit.

Purpose of Form
Use Form 8820 to figure and claim
the orphan drug credit and to elect
the reduced credit under section
280C. The credit is 25% of qualified
clinical testing expenses paid or
incurred during the tax year. See
section 45C and Regulations section
1.28-1 for details.
Taxpayers that are not
partnerships, S corporations,
estates, or trusts, and whose only
source of this credit is from those
pass-through entities, are not
required to complete or file this form.
Instead, they can report this credit
directly on Form 3800.

Definitions
Qualified clinical testing expenses.
Generally, qualified clinical testing
expenses are amounts paid or
incurred by the taxpayer that would
be described as qualified research
expenses under section 41, with two
modifications.
• In sections 41(b)(2) and (3), “clinical
testing” is substituted for “qualified
research.”
• 100% (instead of 65% or 75%) of
contract research expenses are
treated as clinical testing expenses.
Qualified clinical testing expenses
do not include expenses to the
extent they are funded by a grant,
contract, or otherwise by a
governmental entity or another
person.
Clinical testing. Generally, clinical
testing means any human clinical
testing that meets all four of the
following conditions.

1. The testing is carried out under
an exemption for a drug being tested
for a rare disease or condition under
section 505(i) of the Federal Food,
Drug, and Cosmetic Act (Act).
2. The testing occurs after the
date the drug is designated under
Act section 526 and before the date
on which an application for the drug
is approved under Act section 505(b)
(or, if the drug is a biological
product, before the date the drug is
licensed under section 351 of the
Public Health Service Act).
3. The testing is conducted by or
for the taxpayer to whom the
designation under Act section 526
applies.
4. The testing relates to the use of
the drug for the rare disease or
condition for which it was
designated under Act section 526.
Rare disease or condition. A rare
disease or condition is one which
afflicts:
• 200,000 or fewer persons in the
United States; or
• More than 200,000 persons in the
United States, but for which there is
no reasonable expectation of
recovering the cost of developing
and making available a drug in the
United States for the disease from
sales of the drug in the United
States.
The above determinations are
made as of the date the drug is
designated under Act section 526.

in base period research expenses
when figuring the credit for
increasing research activities in a
later tax year.

Testing Not Eligible for the
Credit

Specific Instructions

The credit is not allowed for clinical
testing conducted outside the
United States unless there is an
insufficient U.S. testing population
and the testing is conducted by a
U.S. person or by another person
not related to the taxpayer. Testing
conducted either inside or outside
the United States by a corporation to
which section 936 applies is not
eligible for the orphan drug credit.

Coordination With the
Research Credit
Qualified clinical testing expenses
used to figure the orphan drug credit
cannot also be used to figure the
credit for increasing research
activities. However, any of these
expenses that are also qualified
research expenses must be included

Member of Controlled Group
or Business Under Common
Control
For purposes of figuring the credit,
all members of a controlled group of
corporations (as defined in section
41(f)(1)(A) and (f)(5)) and all members
of a group of businesses under
common control (as defined in
section 41(f)(1)(B)) are treated as a
single taxpayer. As a member, your
credit is determined on a
proportionate basis to your share of
the aggregate clinical testing
expenses taken into account by the
group for the orphan drug credit.
Enter your share of the credit on line
2a. Attach a statement showing how
your share of the credit was figured,
and write “See Attached” next to the
entry space for line 2a.
For purposes of the reduced credit
election, a member of a controlled
group or a trade or business which is
treated as being under common
control with other trades or
businesses may make the election
under section 280C(b)(3). However,
only the common parent (within the
meaning of Regulations section
1.1502-77(a)(1)) of a consolidated
group may make the election on
behalf of the members of a
consolidated group.
Figure any orphan drug credit from
your own trade or business on lines
1 and 2a.
Line 1
Complete Part II for each orphan
drug for which qualified clinical
testing expenses are paid or
incurred during the tax year and
included in line 1.
Line 2a
If you are electing the reduced
orphan drug credit, you must
complete Form 8820 (even if no
orphan drug credits are claimed on
the original return) and clearly
indicate your intent to make the
election. In order for the election to
apply, the Form 8820 must be filed
with your original timely filed
(including extensions) return for the
tax year. Once made, the election is

Page 4

Form 8820 (Rev. 9-2018)

irrevocable for that tax year.
If you do not elect the reduced
credit, you must reduce your
otherwise allowable deduction for
qualified clinical testing expenses by
the amount of the credit on this line.
In a case in which qualified clinical
testing expenses are capitalized,
if the credit exceeds the amount
allowed as a deduction for the tax
year, reduce the amount chargeable
to capital account for the year for
such expenses by the amount of the
excess. Attach a statement to your
tax return that lists the deduction
amounts (or capitalized expenses)
that were reduced. Identify the lines
of your return (schedule or forms for
capitalized items) on which the
reductions were made.
Line 2b
If the credit on line 2a includes
wages paid to employees, and you
are also claiming a credit for
employer differential wage payments
based on wages paid to the same
employees, enter on line 2b the
portion of the credit from the
employer differential wage credit line
(for example, line 2 of Form 8932)
that is attributable to wages that
were also used to figure the credit
on line 2a.
See Form 8932, Credit for
Employer Differential Wage
Payments, for information on the
credit.
Line 5
Allocate the orphan drug credit on
line 4 between the estate or trust
and the beneficiaries in the same
proportion as income was allocated
and enter the beneficiaries’ share on
line 5.

If the estate or trust is subject to
the passive activity rules, include on
line 3 any orphan drug credit from
passive activities disallowed for prior
years and carried forward to this
year. Complete Form 8582-CR,
Passive Activity Credit Limitations,
to determine the allowed credit that
must be allocated between the
estate or trust and the beneficiaries.
For details, see the Instructions for
Form 8582-CR.
Part II
For each drug for which qualified
clinical testing expenses are
included on line 1, enter the generic
name of the orphan drug, the
Designation application number, and
the date the drug was designated
under section 526 of the Federal
Food, Drug, and Cosmetic Act.
Attach as many Part II pages as
needed to show all orphan drugs.
Paperwork Reduction Act Notice.
We ask for the information on this
form to carry out the Internal
Revenue laws of the United States.
You are required to give us the
information. We need it to ensure
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collect the right amount of tax.
You are not required to provide
the information requested on a form
that is subject to the Paperwork
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Revenue law. Generally, tax returns
and return information are
confidential, as required by section
6103.

The time needed to complete and
file this form will vary depending on
individual circumstances. The
estimated burden for individual and
business taxpayers filing this form is
approved under OMB control
number 1545-0074 and 1545-0123
and is included in the estimates
shown in the instructions for their
individual and business income tax
return. The estimated burden for all
other taxpayers who file this form is
shown below.
Recordkeeping . . 2 hr., 37 min.
Learning about the
law or the form . . 1 hr., 00 min.
Preparing and sending
the form to the IRS . 1 hr., 04 min.
If you have comments concerning
the accuracy of these time estimates
or suggestions for making this form
simpler, we would be happy to hear
from you. See the instructions for the
tax return with which this form is
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