This article is more than 5 years old. Information may no longer be current.

Allergan wins patent infringement suit over generic versions of brimonidine

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

IRVINE, Calif. — A U.S. district court ruled in favor of Allergan in a patent infringement suit filed against companies aiming to market generic versions of Alphagan, the company announced in a press release.

A U.S. District Court for the District of Delaware ruled in Allergan's favor against Exela PharmSci Inc., Exela PharmSci Pvt. Ltd., Apotex Inc. and Apotex Corp. Allergan filed the suit claiming the defendants infringed on the patent for Alphagan (brimonidine tartrate ophthalmic solution 0.1% and 0.15%) when seeking U.S. Food and Drug Administration approval of generic versions of the drug.

The court ruled that all five of Allergan patents for brimonidine are valid and enforceable.

Under the Hatch-Waxman Act, a federal law enacted in 1984, a drug manufacturer seeking FDA approval of a generic version of a name-brand product must file an abbreviated new drug application (ANDA) and confirm that it is not infringing on the name-brand patent or that the name-brand patent is expired or invalid.

Under the federal statute, the FDA must delay approval of the defendant's ANDA until the last of the infringed patents expires in 2022, the release said.

"Innovation in medicine has improved lives, reduced suffering and advanced the quality of patient care, and our intellectual property embodies our commitment to and investment in medical innovation," Douglas S. Ingram, Allergan executive vice president, chief administrative officer and secretary, said in the release. "It is only through a respect for intellectual property rights that the cost, time and risk of failure associated with new innovations is justified. Accordingly, this case is a victory not merely for Allergan but for the research and development process that brings new treatment choices to the medical community."