FDA Orange Book – Patent Procedural Update

Posted on 02/06/2018 by Shin Hee Lee, in Articles, Patent Trends & Activity

The Food and Drug Administration (FDA) made a technical change to the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)[1], effective November 21, 2017. The Orange Book will now show patent submission dates where available. A patent submission date is defined as the date on which the FDA receives patent information from the New Drug Application (NDA)[2]  holder, often referred to as the innovator. Previously, patent submission dates could only be ascertained by directly contacting the FDA.

The update is in part fulfillment of the final rule made in October 2016 for Abbreviated New Drug Applications (ANDAs, also known as generic drug applications)[3] and 505(b)(2) Applications (i.e. hybrid drug applications based on previously available data). The stated goal was to “reduce unnecessary litigation, reduce delays in the approval of ANDAs and 505(b)(2) applications that are otherwise ready to be approved, and provide business certainty to both brand name and generic drug manufacturers.” The FDA also intended to enhance transparency of information to enable generic drug manufacturers to plan the earliest date they can market a new generic drug product. The new information is in addition to the previous Orange Book listings for drug products and patent information based on the applicant (company information), dosage form and amount (e.g., tablet or i.v.), patent number, and newly added patents or delisted patents.

To obtain approval for a generic drug product after 4 years while there is still a remaining year of regulatory exclusivity for the innovator, an ANDA filer must fulfil one of the four patent certifications as provided by the FFDCA in § 505(j)(2)(A)(vii), paragraphs (I) through (IV). Specifically, the ANDA applicant must certify that either:

  1. There are no patents listed in the Orange Book (paragraph I)
  2. The listed patent has expired (paragraph II)
  3. The listed patent will expire [before date approval is sought] (paragraph III), or
  4. The listed patent is invalid or will not be infringed (paragraph IV)

If the ANDA contains a paragraph I or II certification, the FDA will review the ANDA for immediate approval. If the ANDA contains a paragraph III certification, the application will be eligible for approval upon patent expiration. If the ANDA contains a paragraph IV certification, then the filer must give notice to the NDA holder and patent holder and provide a detailed statement on factual and legal basis why the patent is not valid or will not be infringed. This of course sets the stage for the complex chain of events leading to ANDA litigation.  Hence knowing the patent submission date could be useful for an ANDA filer to determine an appropriate course of action for the ANDA submission.

Ever since the negotiation and enactment of 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act), continuous efforts have been made by the Congress and FDA to bring low-cost prescription drugs to consumers, while balancing the competing interests of the branded pharmaceutical industry and the generic drug manufacturers.[4] Prior to the Act, it was more difficult for generic drug manufacturers to produce and market their products because the innovators sometimes interfered with the generic filing and approval. Based on public policy arguments, because generic medicines can save U.S. consumers’ expenses, Congress made an attempt to accelerate and heighten incentives for generic manufacturers to file ANDAs while providing protection for the innovators. The Act directed the FDA to require generic manufacturers to demonstrate nothing but their “bioequivalence” to the referenced brand-name drug. “Bioequivalence” means that the generic drug must deliver equal amount of active ingredients to a patient’s bloodstream at the same amount of time as the proprietary drug. As for the innovators, their new drug with a new chemical entity (NCE) receives exclusivity for five years, during which ANDAs cannot be submitted or approved. According to a 2015 IMS Health Institute for Healthcare Informatics report, generic drugs approved under The Hatch-Waxman Act provided a savings to the U.S. healthcare system of $1.68 trillion from 2005 to 2014.[5]

The FDA first began collecting patent submission dates in 2013, which now adds up to approximately 4000 patent records. Knowing the patent submission dates of drugs approved before 2013 will still require contacting the FDA for verification, but all new submission dates will be published in the Orange Book going forward. Although there have been opponents of the change, in the long run, it is likely this information will be an improvement, particularly considering that it was available, but required some digging to obtain it.

More information on this listing change can be found in the FDA’s official announcement here.

-Shin Hee Lee and Anthony Sabatelli, PhD, JD

Shin Hee Lee is a Ph.D. Candidate in the Chemistry Department at Yale University. She is currently associated with the Yale Energy Sciences Institute, where she specializes in organic synthesis of novel light-harvesting dye molecules for solar cells. Prior to attending Yale, Shin Hee obtained her B.S. in Chemistry with High Honors at the University of Michigan – Ann Arbor, during which she published patents and papers on developing synthetic methodologies for fluorinated small molecules.


This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. The opinions expressed in this article are those of the author only and are not necessarily shared by Dilworth IP, its other attorneys, agents, or staff, or its clients.

[1] The Orange Book is a search engine that identifies drug products and patent information. It lists U.S. drug products are approved based only on safety and effectiveness by the FDA, not every product available in the market.

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[2] The New Drug Application (NDA) is a formal application submitted by the drug sponsors to the FDA for approval of a new pharmaceutical for sale and marketing in the U.S.

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[3] The Abbreviated New Drug Application (ANDA) is an application submitted to the FDA for potential approval of a generic drug product for an existing licensed pharmaceutical in the U.S. The Orange Book is utilized to prepare and submit ANDAs.

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[4] The Drug Price Competition and Patent Term Restoration Act. – Pub. L. No. 98-417, 98, Stat. 1585 (1984)

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[5] IMS Health Institute for Healthcare Informatics (April 2015), available at http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports.