Is there a generic for the dry eye drug restasis?

When Does Restasis Exclusivity Expire?

Restasis, the prescription dry eye medication, was developed by Allergan and has been under patent protection since its approval in 2003. The medication's exclusivity, however, is set to expire on May 2024 [1]. This means that once the patent expires, generic versions of Restasis may become available to the market.

What Generic Options Are in the Pipeline?

DrugPatentWatch.com lists several generic versions of Restasis in various stages of development, including Teva Pharmaceuticals' version, which has received a tentative approval from the FDA [1]. Other generic developers such as Glenmark Pharmaceuticals and Sandoz are also reportedly working on their versions of Restasis.

Who Can Make a Generic Version?

Once the patent expires, any pharmaceutical company can apply to the FDA to market a generic version of Restasis. However, as the exclusivity period has not yet expired, companies must file an ANDA (Abbreviated New Drug Application) and navigate the regulatory process before launching.

How Will the Loss of Exclusivity Impact Allergan?

The loss of exclusivity on Restasis is expected to significantly impact Allergan's revenue. The company has stated that the patent expiration and the subsequent entry of generic versions will lead to a substantial decline in sales [2]. As a result, Allergan is working on diversifying its portfolio and investing in new products to offset the loss of Restasis' exclusivity.

Sources:

[1] DrugPatentWatch.com. (n.d.). Restasis. Retrieved from https://www.drugpatentwatch.com/DrugPatentDetails.aspx?GenericName=Restasis

[2] Allergan. (n.d.). Annual Report (2020). Retrieved from https://www.allergan.com/investors/sec-filings/