Upadhye Cwik LLP advises on FDA's 505(b)(2) Application

|Jul 1|magazine6 min read

CHICAGO, July 1, 2020 /PRNewswire/ -- The 505(b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy. The (b)(2) pathway offers certain benefits such as: (i) changes in dosage forms or new combinations to existing approved drug substances; (ii) new indications or new strengths; (iii) an expedited and cheaper pathway to approval because the applicant can rely on existing data. The applicant can often avoid costly and time-consuming new trials when compared to the traditional (b)(1) route.

At Upadhye Cwik 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 unfair 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. We help (b)(2) applicants map the IP and FDA regulatory strategy to ensure that the franchise can be maximized. Why does mapping matter? If the (b)(2) application is entitled to any FDA market exclusivity, then the question arises of 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 (b)(2) pathway is faster than the ANDA route. The (b)(2) can be entitled to market exclusivities. The (b)(2) applicant can also be a "Paragraph IV" defendant in a Hatch Waxman lawsuit the same as an ANDA filer. But because of PDUFA timelines, the (b)(2) applicant wants a faster litigation to terminate any litigation 30-month stay. And upon (b)(2) approval, the applicant will list its own patents into the Orange Book, which invites ANDA challengers to file against the now approved (b)(2) application.

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.

Call Upadhye Cwik LLP at 312-327-3326 or view our website: ipfdalaw.com for more information about our innovative legal practice and how we help solve a client's problems.

Media Contact: Shashank Upadhye, (312)327-3326, [email protected]

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SOURCE Upadhye Cwik LLP