/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

/PRNewswire/ -- Aveva药物递送系统（A DifGen公司），总部位于佛罗里达州米拉马尔的透皮药物递送系统领域的领导者，自豪地宣布美国食品药品监督管理局（FDA）已批准其仿制药

Lidocaine 1.8% Patch

利多卡因1.8%贴剂

, 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

，一种用于治疗带状疱疹后神经痛（PHN）的非阿片类外用药物，为遭受局部神经疼痛的患者提供了一种更实惠、有效且易获得的治疗选择。截至最近12个月的年市场销售额达到

December 2024

2024年12月

were approximately

大约是

$116 million

1.16亿美元

as measured by IQVIA™.

根据IQVIA™的测量。

The generic

通用的

Lidocaine 1.8% Patch

利多卡因1.8%贴片

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..

是一种局部非水凝胶贴片产品，可提供局部剂量的利多卡因，直接在疼痛部位缓解疼痛。通过提供品牌利多卡因贴片ZTlido®的仿制药版本，DifGen旨在改善患者获取优质疼痛管理方案的机会，同时也有助于持续降低医疗成本的努力。

Key Benefits of the generic Lidocaine Patch:

通用利多卡因贴剂的主要优点：

Targeted Pain Relief:

靶向疼痛缓解：

The patch delivers lidocaine directly to the site of pain, allowing for localized treatment.

该贴剂将利多卡因直接递送至疼痛部位，从而实现局部治疗。

Non-invasive Treatment:

非侵入性治疗：

The patch provides a non-oral, non-invasive solution, reducing the risk of adverse reactions generally associated with oral medications.

该贴片提供了一种非口服、非侵入性的解决方案，降低了通常与口服药物相关的不良反应风险。

Ease of Use:

易用性：

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.

该贴片易于使用，并能提供长达12小时的持续缓解，使患者能够以最少的干扰进行日常活动。

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..

根据FDA的批准函，Aveva是首家提交包含第四段认证的完整ANDA申请的企业。因此，Aveva可能有资格获得180天的仿制药独占期，但FDA目前尚未对此独占权作出正式裁定。

'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

“我们很高兴获得首个仿制利多卡因1.8%贴剂的FDA批准，因为这标志着我们在提供全面疼痛管理解决方案的使命中迈出了重要的一步，”

Ramandeep Singh Jaj

兰曼迪普·辛格·贾杰

, 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.'.

，DifGen创始人兼联合首席执行官。Santhanakrishnan Srinivasan博士，创始人兼联合首席执行官补充道：“此次批准凸显了我们在透皮技术方面的卓越理解，我们利用创新方法开发了这款复杂产品，并取得了优越的知识产权地位，为患者提供了一种安全、有效且经济实惠的症状管理新选择。Aveva开发的复杂工艺确保贴片始终按照严格的安全性、有效性和合规标准生产。”

The United States

美国

District Court for the Southern District of

南区地区法院

Florida

佛罗里达州

previously dismissed the patent infringement case in favor of Aveva Drug Delivery Systems.

此前驳回了对Aveva药物输送系统有利的专利侵权案。

About DifGen:

关于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是一家总部位于美国的全球制药公司，主要专注于开发复杂、高壁垒的仿制药和特种制药产品，这些产品有助于提高高质量药物的可及性，从而为创建下一代健康社区做出贡献。

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..

DifGen始终致力于挑战标准思维过程，以得出可靠的解决方案，从而在产品开发、质量、临床事务、监管科学和商业战略方面实现范式转变。该公司拥有一个才华横溢的团队，其中一些最聪明的人才对与各种治疗领域和广泛剂型（如注射剂、眼科用药、外用药物、生物制品、药械组合、软胶囊、固体口服制剂和混悬剂）相关的独特、商业可行且复杂的产品线的细微差别建立了全面的理解。

About Aveva:

关于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药物输送系统（DifGen公司旗下）是一家完全集成的无菌产品、透皮输送系统（TDS）和口腔溶解膜（ODF）的开发商和制造商。Aveva获准生产、包装和销售OTC和处方TDS及ODF产品，并获得美国缉毒局（DEA）批准，可存储和处理第二类和第三类管制物质。