The FDA’s Off-Patent, Off-Exclusivity Drug List: Enhancing Market Competition and Drug Accessibility

by | Jun 27, 2024 | CDC, Compliance, FDA, Global Leader, GMP, Healthcare, Immunization, Medicine, Pharma, Pharmaceuticals, Product Development, QMS, Quality, Quality Systems, Regulatory, Requirements, Testing, Vaccine

The high cost of prescription drugs remains a significant concern for many Americans. In an effort to combat this issue and promote greater competition in the pharmaceutical market, the FDA has implemented several strategies. One of the notable initiatives is the publication of the Off-Patent, Off-Exclusivity (OPOE) Drug List. This list is a valuable resource aimed at facilitating the entry of generic drugs into the market, thereby increasing competition and ultimately reducing prices for consumers.

The OPOE Drug List, published by the FDA, identifies drug products that are no longer protected by patents or exclusivity rights. These drugs can be legally produced as generics by other manufacturers without the risk of infringing on intellectual property rights. The list serves several key purposes:

  • Promoting Market Entry: By clearly identifying drugs that are off-patent and off-exclusivity, the FDA provides generic drug manufacturers with a clear target for product development. This can expedite the process of bringing generic versions of these drugs to market.
  • Increasing Transparency: The list enhances transparency within the pharmaceutical industry, providing stakeholders with critical information about which drugs are open to generic competition. This can lead to a more competitive and dynamic marketplace.
  • Encouraging Competition: The ultimate goal of the OPOE Drug List is to increase competition among drug manufacturers. When more generic options are available, it can lead to lower prices and greater accessibility for patients.

The OPOE Drug List is regularly updated by the FDA and is available on their website. It includes comprehensive information about each drug product, such as active ingredient, dosage form, route of administration, strength, and reference listed drug (RLD). The RLD is the standard to which generic versions are compared to demonstrate bioequivalence.

The impact of the OPOE Drug List can be seen in several areas, first is faster development and approval of generics. Generic drug manufacturers can use the OPOE Drug List to identify opportunities for product development. This can lead to faster submission of Abbreviated New Drug Applications (ANDAs) and, ultimately, quicker approval and market entry of generics.

Additionally, increased competition typically results in lower drug prices. By facilitating the entry of generics, the OPOE Drug List helps make medications more affordable for consumers.

Lower prices and a greater number of available generic options can improve access to essential medications, particularly for underserved populations and those without comprehensive insurance coverage.

The FDA’s Off-Patent, Off-Exclusivity Drug List is a powerful tool in the ongoing effort to increase competition in the pharmaceutical market and reduce drug prices. By providing clear and accessible information about drugs that are open to generic competition, the FDA encourages the development of more affordable generic options. This initiative not only benefits consumers by making medications more affordable but also promotes a more dynamic and competitive pharmaceutical industry.

With expertise in regulatory, quality, and compliance, as well as operations and clinical services, EMMA International is your single source pharmaceutical consulting solution. Call us at 248-987-4497 or email to learn more today.

FDA (June 2024) List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic retrieved from:

EMMA International

EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.

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