Orange Book Blues

The Food and Drug Administration's update of its Orange Book added the drugs approved last month, including VIVUS' (Nasdaq: VVUS  ) Qsymia and Onyx Pharmaceuticals' (Nasdaq: ONXX  ) Kyprolis.

But the entry for Amarin's (Nasdaq: AMRN  ) Vascepa isn't complete. As expected from a company SEC disclosure earlier, the entry includes patents, but doesn't include the regulatory exclusivity status of Vascepa.

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 (NYSE: GSK  ) fish oil Lovaza. The FDA is still working through its decision about whether the drugs are different enough to classify Vascepa as new.

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.

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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.
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Read/Post Comments (3) | Recommend This Article (2)

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  • Report this Comment On August 20, 2012, at 11:21 AM, skm1965 wrote:

    Isn't VIVUS product a combination 2 other products?

    Then how did it get NCE?

  • Report this Comment On August 20, 2012, at 11:41 AM, TMFBiologyFool wrote:

    VIVUS' Qsymia didn't get NCE. It's listed as a NC (New combination), which gives the drug a 3 year exclusivity that run concurrently with patents.

  • Report this Comment On August 20, 2012, at 4:27 PM, idahithat wrote:

    A PhD put to the test with all the meat and doritos of just another yahoo post.

    Although; Lovenox or leave it.

    "Today, there are many improved products on the market consisting of so-called low molecular weight heparins (LMWHs) that are produced by further refining and processing heparin to improve safety and efficacy... Compared to the above examples, the LMWHs are much more applicable to AMR101, and in my opinion offer support for granting NCE status to AMRN -"

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