FDA Asks Industry to Shoot for the Stars in Enhancing the Orange Book

July 1, 2020

Blasting off into summer, the U.S. Food and Drug Administration (FDA) is soliciting feedback from the industry about what they would want to see added to the Orange Book. FDA’s Orange Book (also known by its less-used formal name, “Approved Drug Products with Therapeutic Equivalence Evaluations”) is a useful resource for many in the pharmaceutical industry, including drug companies, prescribers, health agencies, pharmacies — and even their lawyers.

The Orange Book lists FDA‑approved branded and generic drug products, as well as patent and exclusivity information related to those products. It also includes therapeutic equivalence information for marketed prescription drugs, which can be used to determine if one drug product is a “pharmaceutical equivalent[] for which bioequivalence has been demonstrated, and [] can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling” as another drug product.[i]

Recent publications show that FDA is interested in making the Orange Book an even more useful tool for the pharmaceutical industry. Earlier this month, FDA issued draft guidance setting forth “Orange Book Questions and Answers” about the content and format of the Orange Book, petitioned Abbreviated New Drug Application (ANDA) information, withdrawn and discontinued products, and patent listings. In addition to seeking comment on this publication, the FDA sought commentary from industry stakeholders concerning use of the Orange Book.[ii]

In its first notice, FDA seeks information on who uses the Orange Book, what sections they consult and why, and information about the use and potential enhancements to the therapeutic equivalence information included in the Orange Book. FDA also inquired specifically about whether and how the therapeutic equivalence information promotes drug competition.

The second notice focuses on patent information listed in the Orange Book. FDA seeks input on several issues related to the types of patents that can be listed in the Orange Book. The FDA is interested in whether, and to what extent, drug-device combination patents (i.e., those that claim a device as part of a combination drug-device product approved under Section 505 of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 355) should be among the patents listed. It also inquires whether patents covering Risk Evaluation and Mitigation Strategies (REMS) or drug-related digital applications should be listed.

Any changes to the Orange Book could be significant for different industry players in a variety of ways. Private drug databases, such as First Databank and Medi-Span, gather and list information from the Orange Book in their databanks. This information can be relied on in making decisions regarding how generics are related to brand-named drugs. Changes may have downstream implications for databanks and how drugs are listed and populated at the pharmacy level. Those in the industry should think carefully about what information they want listed in or excluded from the Orange Book. McGuireWoods’ life sciences team has specific experience with FDA regulatory issues and related Hatch-Waxman patent litigation. Our team is ready to assist with challenges arising in FDA-regulated industry.


[i] See 21 C.F.R. § 314.3(b).

[ii] See 85 FR 33165; 85 FR 33169.

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