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Tapping Into the Unexplored Through 505(b)(2) Pathway

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Filing a drug through the 505(b)(2) regulatory pathway comes with substantial benefits. The enactment, enforced in 1984, allows applicants to use the existing safety and efficacy data of listed drugs to fast-track new drug entities to market. The Drug Price Competition and Patent Term Restoration (also known as the Hatch-Waxman Amendments) added sections 505(b)(2) and 505(j) to the FD&C Act creating new routes for obtaining approval for NDAs and ANDAs.

Like 505(b)(1), 505(b)(2) is an NDA that sidesteps the safety and efficacy assessments of a drug, cutting down the development time by years.

Let’s review the three statutes that govern the approval pathways:

  1. 505(b)(1), the regular route for new drug entities that have never been studied or approved before, is a high-risk, high-reward investment. It is a time-consuming and resource-intensive passage. The process involves completing pre-clinical and clinical studies establishing the safety and efficacy of the molecule for a specific disease. The entire drug development process is a multi-million-dollar affair with a time frame of 10-15 years and with not much assurance as to whether the drug will meet regulatory expectations.
  2. This is where 505(b)(2), comes with a faster route to launch. The novel idea behind introducing this pathway was to leverage existing studies leading to speedy approval of drugs. Contingent on the factors in play, the development time shrinks to 2-4 years. the key for the drug sponsor is to prove a significant modification to the existing drug, which could be a change in dosage, route of administration, formulation, adding new indications, changing from prescription to OTC, new combinations (including two separately approved API) or substitution of an active ingredient in a combo product.
  3. Last but not least, 505(j) is a pathway to develop generic versions of the previously approved drug products. Instead of an NDA, the sponsor of the generic drug submits an ANDA for market approval. There may be slight differences in size or shape but they must have the same active ingredient as proven through bioequivalence assessment.

Utilizing 505(b)(2) also guarantees three to five years of market exclusivity —five years if the drug has never been approved in any form in the US and three years if approved. Small or mid-level pharma companies with limited R&D capital and resources can take strides to develop new drugs or simply repurpose or reposition a marketed drug through this route. It is common for companies to extend their patented drugs to other indications to obtain further regulatory exclusivity. More NDAs are approved annually through this regulatory pathway than 505(b)(1).

Using 505(b)(2) Pathway to Repurpose a Drug

The benefits behind repurposing a pipeline or marketed drug could be exploring or expanding its potential, which could be efficacy, improved formulation, safety, or indication expansion. It is also correct to assume repurposing becomes relatively easier if going with an FDA-approved drug, without modifying the route of administration and maintaining the same dosage as the approved product.

A sponsor company is also responsible for conducting pre-clinical and clinical research of the drug in focus in case the published literature is insufficient to support safety and efficacy and is pivotal for successful approval. FDA’s detailed guidance document: Applications Covered by Section (505(b)(2) feature application and process details, what can or cannot be submitted, what to include in the application, patent and exclusivity protection clauses, etc.

Societal™ CDMO, with its extensive experience and expertise in developing and manufacturing products utilizing 505(b)(2) regulatory pathway, can assist at every step from the development of the formulation and analytical method, cGMP manufacturing of the product for bioequivalence or registration, preparing and submitting IND application to NDA consultation, planning and preparation of the regulatory document, support for responding to FDA questions during the review process and post-approval product management. Societal has a team of regulatory experts ready to partner with you through your drug approval process. To explore our regulatory offering and services, click here.

Jagjyot (Jot) Kaur
Market Intelligence Manager
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