Class action lawsuit gabapentin?

See the DrugPatentWatch profile for gabapentin

Why are companies challenging this patent?

The gabapentin class action lawsuit primarily involves companies that manufactured and sold gabapentin, a generic anticonvulsant and analgesic. The lawsuit revolves around the patent protection for gabapentin held by Pfizer, the original patent holder. [1]

What's the patent issue all about?

Pfizer's patent (US Patent 4,764,435) for gabapentin was set to expire in 2004. However, a series of extensions granted to Pfizer due to clinical trial exclusivity, pediatric exclusivity, and changes in exclusivity laws, prolonged the patent life. This led to a protracted period of market exclusivity, allowing Pfizer to maintain control of the market. [2]

How long did exclusivity last?

The gabapentin patent has been repeatedly extended through the years. The patent initially expired in 2004 but received extensions until 2017. This protracted delay in market launch meant many generic competitors, including Teva Pharmaceuticals and Apotex, faced patent-related obstacles.

What's happening now?

On September 24, 2012, the FDA approved several generic versions of gabapentin from companies such as Teva, Actavis, Mylan, and Apotex. However, these generic versions did not become widely available until the patent expired in 2018 (extended protection expired). [3]

When does exclusivity expire?

After the patent for gabapentin finally expired in 2018, Teva Pharmaceuticals USA and Mylan Pharmaceuticals were able to bring their generic product to market, making gabapentin significantly more affordable for patients. [4]

What does this mean for consumers?

The gabapentin class action lawsuit aimed at addressing concerns that companies extended gabapentin's patent life unfairly, leading to higher prices for consumers.

Sources:

[1] DrugPatentWatch.com

[2] DrugPatentWatch.com

[3] FDA

[4] BusinessWire