FDA’s 505(b)(2) Application

The 505(b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy for clients. This hybrid NDA application helps avoid duplicative and costly studies that others have already completed. FDA’s rules allow (b)(2) applicants to rely on this prior body of work. And because of this reliance, the (b)(2) development is cheaper and faster towards full FDA approval when compared to the traditional (b)(1) route. ANDAs are much less intense because they only require the pharmaceutical company to show that the generic drug is comparable to an existing product that has already been approved.

At Upadhye Tang LLP, we combine our understanding of FDA, IP, and commercial law to help (b)(2) clients come to market with new products and protect them from competition. We use our keen understanding to develop an IP strategy that maps with the FDA development timelines and FDA market exclusivities, and build the commercial legal issues to protect new products.

Benefits of the 505(b)(2)

Sometimes, however, a new drug is neither strictly a generic, nor an entirely new molecular entity. In such cases, the 505(b)(2) application may be the pathway of choice. If the drug is similar to an existing drug but has certain new traits, such as form of dosage, strength, indication, or how it interacts with other drugs, the 505(b)(2) pathway is likely a superior option to the standard NDA.

Drug manufacturers can submit their application to the FDA using data collected by another manufacturer, but it is up to the submitting manufacturer to show a connection between the reference drug and their own. If this connection can be shown, the FDA may approve the new drug without requiring new pre-clinical studies or major clinical trials.

The (b)(2) pathway can be used to create a new franchise of drug products. And when done properly, the FDA pathway will map alongside the IP and commercial strategy.

Why does mapping matter? If the (b)(2) application is entitled to any FDA market exclusivity, then the question for the company or its investors is whether any additional protection can exist beyond the FDA market exclusivity. As such, it is important to know if any IP or commercial protection can exist beyond any 3/5/7 year market exclusivity.

505(b)(2) vs. ANDA

The easier application process is an obvious benefit of gaining approval through 505(b)(2) rather than NDA, but why is it better than the ANDA process for generics? Well, one clear advantage is that 505(b)(2) drugs are eligible for up to seven years of market exclusivity, whereas the exclusivity period for ANDA-approved generics is only six month, if at all. Also, in certain drug products, an ANDA must copy the branded reference product in order to be Q1/Q2 compliant. As such, the copying of the branded product may result in adverse formulation patent consequences. So, the 505(b)(2) pathway may allow certain ingredient switching to occur that may result in the company avoiding another’s patent and/or permits the acquisition of its own patents. Considering that the drug is protected from competitors as long as it has market exclusivity, this is an exceedingly important distinction.

505(b)(2) vs. ANDA Similarities and Dissimilarities

Many times, the (b)(2) applicant may need to certify to the reference product’s Orange Book patents. The certification process is similar to the ANDA Paragraph IV process. And then (b)(2) applicant may be engaged in patent litigation and laboring under the litigation 30-month stay. But while the (b)(2) applicant may be subject to Paragraph IV litigation, it does not obtain the 180-day market exclusivity that ANDA filers may obtain.

How we help strategy, execution, and what to think about

We help 505(b)(2) applicants strategize the timelines for FDA approval, FDA market exclusivities, how the patent portfolio maps onto the product and timelines, how to expedite any patent litigation to resolution so that FDA approvals can be leveraged, and how arguments raised in any Paragraph IV litigation against any original brand company could backfire when the (b)(2) applicant is a plaintiff-patentee against later ANDA filers.

Contact Upadhye Tang LLP Today

Many drug manufacturers have already realized the benefits of the 505(b)(2) application, and it is expected to be a preferred pathway for the foreseeable future. At Upadhye Tang LLP, our highly-knowledgeable FDA compliance attorneys have extensive experience with each pathway to FDA approval. We have helped countless clients bring new drugs to market in the quickest, safest, and most cost-effective manner possible. If you would like more information about the 505(b)(2) application process and how to determine eligibility, contact us today at: shashank@ipfdalaw.com or 312-327-3326.


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