Authorized Generics

Many small to mid-size branded pharmaceutical companies have yet to discover the secret that large pharma organizations have recognized for years. Authorized generics are usually good for business.

Between 2017 and 2022, approximately 350 authorized generics were launched in the US. According to the FDA, there are now approximately 1,200 authorized generic drugs approved in the US.

What these companies understand, is that the seeming contradictory strategy of launching an authorized generic can potentially have big benefits which include:

1. Increased profitability (greater access to coverage with less exposure to high rebates)

2. Market share protection from future generic competition

3. Regulatory advantages allow the AG to launch quickly utilizing the brand’s NDA

There is also the possibility of forestalling future generic competition by limiting their potential margins and profitability. This is especially true with IP-protected brands with revenues in the $50m-$75m range. It has less of a deterrent effect with larger products since market size matters.

This is why you should consider if an authorized generic strategy makes sense for your patented branded product.

The leadership team at Vitruvias has deep experience with both brands, authorized generics, and generics, and understands the hesitancy many decision makers have about intentionally eroding their branded revenue stream. However, once the dynamics of this approach is fully understood, the validity of an AG strategy makes total sense.

And best of all, because we’ve created a compact, highly efficient distribution platform, we can offer this service for less $$$.

Give us a call at 334-329-5601 and let’s discuss. Your balance sheet will thank you.