Aveva Drug Delivery systems (A DifGen company) Announces First FDA Approval of Generic Lidocaine 1.8% Patch for the Treatment of Nerve Pain

MIRAMAR, Fla., March 26, 2025 /PRNewswire/ -- Aveva Drug Delivery systems (A DifGen company), a leader in transdermal drug delivery systems based out of Miramar - Florida is proud to announce that the U.S. Food and Drug Administration (FDA) has granted approval for its generic Lidocaine 1.8% Patch, a non-opioid topical treatment for post-herpetic neuralgia (PHN), providing patients suffering from localized nerve pain with a more affordable, effective, and accessible treatment option. Annual market sales for the 12 months ending December 2024 were approximately $116 million as measured by IQVIA™.

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.

Key Benefits of the generic Lidocaine Patch:

1. Targeted Pain Relief: The patch delivers lidocaine directly to the site of pain, allowing for localized treatment.
   
   
2. Non-invasive Treatment: The patch provides a non-oral, non-invasive solution, reducing the risk of adverse reactions generally associated with oral medications.
   
   
3. 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. Dr. 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.

About DifGen:

DifGen is a US based Global Pharmaceutical company with a primary focus on developing complex high barriers to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. DifGen consistently aspires to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. The firm has a talented team with some of the brightest minds who have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmic, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.

About Aveva:

Aveva Drug Delivery Systems (a DifGen company) is a fully integrated developer and manufacturer of Sterile products, Transdermal Delivery Systems (TDS) and Oral Dissolvable Films (ODF). Aveva is licensed to manufacture, package and market OTC & Rx TDS and ODF products and is DEA approved for Schedule II & III controlled substance storage & handling. Aveva's licensed facilities located in Miramar, FL are spread across 4 sites totaling 210,000 sq. ft.

Media Contact:
Dr Srinivasan Vedantham
954-430-3340
[email protected]

SOURCE Aveva Drug Delivery Systems Inc