The Food and Drug Administration's update of its Orange Book added the drugs approved last month, including VIVUS'
But the entry for Amarin's
The Orange Book's official actual title is Approved Drug Products with Therapeutic Equivalence Evaluations, but Selecting Drugs to Copycat (for Dummies!) might be a better title. It lists all the patents for branded drugs that keep generic versions off the market. Only drugs approved under the New Drug Application are included, so biologics like Abbott Labs' Humira and Amgen's Epogen aren't listed.
In case you're wondering, it's called the Orange Book because when there was a printed version, the cover was orange (back story here). But it's now available as a PDF -- with an orange cover page for posterity -- and a searchable database on the FDA's website.
Generic-drug makers can challenge patents in the Orange Book, and the FDA rewards the first company that's successful with a six-month generic exclusive before approving other generics.
In addition to the patents, the Orange Book lists other exclusivities that keep generics at bay. For example, new chemical entities, or NCEs, get five years of exclusivity. The term runs concurrent to the patents, but keeps generic-drug makers from challenging patents and applying to sell a generic immediately after approval.
It's the NCE status that's at question for Vascepa, a fish oil product that's more purified than GlaxoSmithKline's
In the long run, it'll be Amarin's patents that protect Vascepa, but gaining NCE status is helpful in that it buys Amarin, or whoever buys the company, some breathing room. Unfortunately, it looks like investors will have to wait until at least next month's update to get a ruling.
The biggest binary event, the presidential election, is around the corner. Check out the Fool's new free report, "These Stocks Could Skyrocket After the 2012 Presidential Election," where you'll get ideas for companies that can benefit from each candidate's platform. Get your free copy by clicking here.
Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Abbott Laboratories. The Motley Fool has a disclosure policy.
We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.