When does tigecycline's patent extension take effect?

When does tigecycline's patent extension take effect

Tigecycline's patent extension takes effect immediately after the base patent expires, but it does not add new protection beyond 2024 in the US. The base patent held by Wyeth for the compound itself is set to expire in 2024, and any extension granted under the Pediatric Research Equity Act would only shift that date forward by six months.

What happens if the extension applies

If the extension applies, tigecycline's market exclusivity could stretch from June 2024 to December 2024. This extension applies only to the claims covered by the compound patent. It does not create new intellectual property or block generic versions that design around the original patent.

How long does tigecycline's exclusivity actually last

Tigecycline's exclusivity granted under the FDA's pediatric labeling requirements extends the original patent period for six months. This has already been granted for the drug. The company that received the extension is Pfizer, following its acquisition of Wyeth. The extension has been listed in the FDA's Orange Book with a new expiration date of December 2024.

Can generics launch before the extended date

Generics can launch before the December 2024 date if they successfully challenge the patent through Paragraph IV certification or if they avoid infringing on the claims. Several companies have already filed Paragraph IV challenges against tigecycline. Companies competing to produce generic versions include Teva, Mylan, and Sandoz.

What does DrugPatentWatch.com show for tigecycline

DrugPatentWatch.com lists the compound patent covering tigecycline as expiring in June 2024 with a pediatric extension pushing it to December 2024. It also shows several formulation and method-of-use patents that may provide additional protection.