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Patent Listing in FDA's Orange Book
For over 40 years, the U.S. Food and Drug Administration patents b
(FDA) has maintained a resource formally titled Approved methods
Drug Products with Therapeutic Equivalence Evaluations. administ
This frequently updated publication-now available as a brand-na
searchable online database-is more commonly called the which m
Orange Book after the color of the print version's cover.
Pateni
The Orange Book Only cer
The Orange Book lists all of the nonbiologic (a.k.a. small- the Oran
molecule) drugs approved by FDA to be marketed in the approval
United States. (Biological products, which are drugs applicati
derived from living organisms-such as vaccines, blood drug an
components, and monoclonal antibodies-are listed in a a drug pr
separate FDA publication known as the Purple Book.) (2) clai
Along with information about the approved drugs (e.g., is sought
dosages and forms), the Orange Book includes FDA's informat
therapeutic equivalence evaluations-that is, the approved in the Or
products that are pharmaceutically equivalent and
bioequivalent to another approved product (e.g., a generic FDA reg
form of a brand-name drug). Finally, the Orange Book claiming
includes information on patents and regulatory exclusivities patents c
that may protect a brand-name drug from generic NDA. A
competition. in the Or
The Orange Book serves as an important resource for health Brand-n
care providers and the pharmaceutical industry. Health care in courts
providers may use the Orange Book to determine the Orange
regulatory status of a product (e.g., whether a drug has been Pharma
approved by FDA or if an approval has been withdrawn). Circuit h
Pharmacists may use the Orange Book to determine and miti
whether a therapeutically equivalent generic form of a drug not have
is available to substitute when they fill a prescription patents o
written for a brand-name drug. First Cir
For drug manufacturers, the Orange Book's information on should n
a drug's patents and regulatory exclusivities can be critical Federal
to whether and when generic competition occurs. (For more Amneal
information, see CRS Report R46679, The Role of Patents dose ink
and Regulatory Exclusivities in Drug Pricing.) from te
Pharnaceutca' Patents FDA to
Patents are a form of intellectual property that protect new patents i
inventions. To obtain a patent, an inventor must file a patent
application with the U.S. Patent and Trademark Office The FI
(USPTO). USPTO reviews the application and grants a FDA do
patent only if the claimed invention meets the statutory NDAs to
requirements. A patent's term lasts for about 20 years. drug or a
Like any other invention, pharmaceutical-related Orange
innovations must be new, useful, nonobvious, and FDA me
sufficiently described to be patented. For example, if a compani
person synthesizes a new chemical with potential use for should b
treating human disease, she may obtain a patent on that raised co
chemical itself (an active-ingredient patent). Pharmaceutical may list
manufacturers often obtain many other types of drug generic c
Updated December 27, 2024
eyond the active ingredient, including patents on
of using a drug, drug formulations, devices to
er a drug, and methods of making a drug. A single
me drug may thus be protected by multiple patents,
iay expire at different times.
t Lkst ng in the Orange ooak
rtain types of pharmaceutical patents are included in
ge Book. By statute, a company seeking FDA
of a new drug must include in their new drug
on (NDA) any patent that either (1) claims the
d is a drug substance (active ingredient) patent or
oduct (formulation or composition) patent; or
ms a method of using such drug for which approval
. If the drug is later approved by FDA, the patent
ion in the NDA (along with any updates) is listed
ange Book with the drug.
ulations provide that [p]rocess patents, patents
packaging, patents claiming metabolites, and
laiming intermediates must not be included in an
s a result, these types of patents should not be listed
ange Book per FDA regulation.
ame and generic drug manufacturers have disputed
whether certain patents should be listed in the
Book. In Jazz Pharmaceuticals v. Avadel CNS
ceuticals, the U.S. Court of Appeals for the Federal
eld that a patent on a computerized risk evaluation
gation strategy (REMS) system for a drug should
been listed in the Orange Book. With respect to
n drug devices, the U.S. Court of Appeals for the
cuit held in In re Lantus Direct Purchaser Antitrust
Litigation that a patent on a device for injecting a drug
ot have been listed in the Orange Book, and the
aCircuit reached the same conclusion in Teva v.
Pharmaceuticals regarding patents on metered-
ialers. A 2022 report from FDA and a 2023 report
Government Accountability Office reveal varied
stakeholder views on these issues, with some calling for
clarify the rules for listing REMS and device
n the Orange Book.
TA's M'nstera Role
es not actively police the patent information in
make sure that the listed patents in fact claim the
method of using the drug. FDA maintains that it
lacks expertise in patent law and that its role with respect to
Book patents is only ministerial. In other words,
rely lists the patent information provided by drug
es without independently verifying that the patent
e listed in the Orange Book. This approach has
ncerns among some commentators that NDA filers
inapplicable patents in the Orange Book to deter
ompetition.](ViewImageLocal?handle=hein.crs/goveruy0001&div=1&collection=&method=preview&ext=.png&size=3)
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