Complex transdermal generic drug receives approval, enters market

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/	B. Boissonnet)
(Image: Getty/ B. Boissonnet)

Related tags: Drug delivery, Drug delivery systems, Drug delivery technology, Generic drug, Generic drugs, formulation, Biosimilars

Amneal received approval of a generic of the Exelon patch, a complex generic transdermal drug delivery system, and plans to commercialize the product.

The Exelon patch is used for the treatment of Alzheimer’s disease through transdermal drug delivery.

Amneal is not the first company to receive approval on a rivastigmine patch, and according to IQVIA, the US market annual sales for rivastigmine transdermal systems was estimated, in November of 2018, to be $225m (€197m). A report​ stated that the market for these types of drugs is potentially lucrative.

The company told us that this is its first transdermal approval. The company, which is focused on developing, manufacturing, and distributing generic and biosimilar products, stated that this approval demonstrates its ability to develop complex generic and biosimilar products.

In October 2018, the US Food and Drug Administration released guidance documents​ on the development of generic transdermal and topical delivery systems. The guidance stated that these drugs have complicated formulation and delivery systems, which makes them harder to make into generics.

Transdermal indications and restrictions

Transdermal drug delivery patches are being explored for a number of indications​ but the use of this drug delivery method for Alzheimer’s disease is not new. Corium previously developed Aricept​ (donepezil), a transdermal treatment for the behavior and cognition of individuals with Alzheimer’s disease.

The drug delivery system has been noted to improve drug adherence while reducing gastrointestinal side effects, as it bypasses the gastrointestinal tract. Experts state that adherence and reduction of side effects are particularly important for those with Alzheimer’s disease.

However, Faz Chowdhury, an expert on transdermal and topical drug delivery systems previously told us​ that there are only a small number of drugs that are on the market for this type of delivery, as most drugs do not have the right properties to be able to penetrate the skin.

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