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What Is the FDA 505b2 Pathway?

Updated: Feb 23

How does the FDA 505b2 Pathway work, what are the benefits of this pathway, and what are some of the products approved using this pathway?

The 505b2 New Drug Application (NDA) pathway is a new streamlined NDA process that will allow applicants to rely on studies or investigations conducted by a 3rd party rather than having to conduct their own studies, research, or analysis.

So, what does this mean for someone potentially considering releasing a new drug? 

What is the 505b2 NDA Pathway?

Scientist doing research

The 505b2 pathway would allow them to apply for drug approval without repeating the same investigations, studies, or research that other drug companies have already done. Instead, they could cite these previously cited studies without the express permission of the original applicant.

First introduced by the Hatch-Waxman Amendments in 1984, the purpose of the 505b2 Pathway was to assist in avoiding any unnecessary duplication of research when a company was applying for an improvement on an already approved drug that wasn’t initially developed by them.

One of the most significant benefits of the 505b2 Pathway is that it considerably decreases application processing times and costs when compared to traditional development pathways, such as the 505b1 NDA Pathway.

There are a variety of different marketing applications that could utilize the 505b2 pathway, including:

  • Branded Generic Drugs

  • DESI (Drug Efficacy Study Implementation) Drugs

  • Drug-Device Combinations

  • Prodrugs 

  • Orphan Drugs

Understanding the 505 Regulatory Pathways

Currently, there are three FDA drug approval pathways for any new drug application and abbreviated drug applications (ANDA). The three pathways are:

  1. 505(b)(1) NDA – 505b1 is the complete NDA application pathway for new drug applications. Any studies, research, or trials are required to be conducted by the sponsor of the application, and the data obtained is the primary source of information used by the FDA to determine approval for the release of the drug for United States patients. Of all three processes, 505b1 is the most time-consuming and expensive for pharmaceutical companies.

  2. 505(j) ANDA – When a drug patent is close to expiration, the 505j ANDA pathway is used to approve a generic version of the drug. The main requirements for the 505j ANDA pathway are a demonstration of bioequivalence vs. the innovator product and, in most cases, a food effect study if the new drug will be available in an oral form.

  3. 505(b)(2) NDA – The 505b2 NDA pathway incorporates elements of both the 505b1 and 505j pathways. It’s commonly referred to as a hybrid application because it blends both old and new information as part of the application. 

What Drugs Have Used the 505b2 NDA Pathway?

Various medications

Since the introduction of the 505b2 Pathway, several notable drugs and drug companies have utilized the pathway and process to streamline their applications.

Some examples include:

  • Yosprala™ (aspirin-omeprazole) – Innovida Pharmaceutique.

  • Xuriden™ (uridine triacetate) – Wellstat.

  • Narcan® Intranasal (naloxone hydrochloride) – Adapt Pharma.

  • Omnitrope® (somatropin rDNA origin) – Sandoz.

  • Zuplenz® (ondansetron) – Strativa.

Before a drug company attempts to use the 505b2 Pathway, they first need to identify if their drug meets the requirements of the streamlined process. Below are some potential candidates for the 505b2 Pathway:

  1. Drugs with new active ingredients.

  2. Drugs that have new indications.

  3. Drugs with a change to dosage, formulation, strength, or administration.

  4. New drug combination products.

  5. Prodrugs of any existing medicines.

What Are the Potential Benefits of the 505b2 Pathway?

There are a variety of different reasons why the 505b2 Pathway is beneficial to pharmaceutical companies. The most significant benefit of the 505b2 Pathway is that it reduces the amount of time and money pharmaceutical companies need to invest when compared to a traditional complete application under the 505b1 Pathway.

Other benefits of the 505b2 Pathway include:

  • Potentially eliminate the need for some nonclinical studies, efficacy, and safety tests.

  • Reduced risk due to the prior approval of similar drugs.

  • Faster development streamlined the application process and reduced costs. 

  • The potential to qualify for 3-7 years of exclusivity.

More Affordable, Streamlined Process

a clock and a piggy bank

The 505b2 Pathway provides pharmaceutical companies with a more affordable, faster, and streamlined process, which enables them to save time and money repeating studies or tests that have already been completed and verified.

The end result of the 505b2 Pathway is that pharmaceutical companies have the opportunity to use this pathway to release generic versions of drugs that have had their patents or exclusivity period expire, ultimately bringing more generic drugs to market. 

If you would like to learn more about generic drugs and the role they play, check out this article: Why Are Generic Pharmaceutical Drugs Important?

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