Aveva Drug Delivery Systems obtains FDA OK for generic lidocaine patch

Aveva Drug Delivery Systems has received permission from the Food and Drug Administration for its generic lidocaine 1.8% patch, a non-opioid topical treatment for post-herpetic neuralgia.

The generic lidocaine 1.8% patch is a topical non-hydrogel patch product that delivers a local dose of lidocaine, offering relief directly at the site of pain. By offering a generic version of the branded lidocaine patch ZTlido, DifGen aims to improve patient access to quality pain management options while also contributing to the ongoing effort to reduce healthcare costs, the company said.

Aveva Drug Delivery Systems said key benefits of the generic lidocaine patch include:

• Targeted Pain Relief: The patch delivers lidocaine directly to the site of pain, allowing for localized treatment.
• Non-invasive Treatment: The patch provides a non-oral, non-invasive solution, reducing the risk of adverse reactions generally associated with oral medications.
• Ease of Use: The patch is easy to apply and offers continuous relief for up to 12 hours, allowing patients to go about their daily activities with minimal disruption.

According to the FDA approval letter, Aveva was the first applicant to submit a substantially complete ANDA containing a Paragraph IV certification for this product. Therefore, Aveva may be eligible for 180 days of generic drug exclusivity, but FDA has not made a formal determination on exclusivity at this time.

"We are thrilled to receive the first FDA approval for the generic Lidocaine 1.8% Patch, as it marks a significant milestone in our mission to provide comprehensive pain management solutions," said Ramandeep Singh Jaj, founder and co-CEO of DifGen. 

Santhanakrishnan Srinivasan, founder and co-CEO added, "This approval underscores our superior understanding of the transdermal technology, where we used our innovative approach to develop this complex product with a superior IP position, resulting in a new option to patients for managing their symptoms in a safe, effective and affordable manner. The intricate process developed by Aveva ensures that the patches are consistently produced to meet strict safety, efficacy and compliance standards."

The United States District Court for the Southern District of Florida previously dismissed the patent infringement case in favor of Aveva Drug Delivery Systems.

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The patch had a market value of roughly $116 million for the 12 months ending December 2024, per IQVIA.