[Ip-health] 2010 FDA (NME) drug approvals: few were based upon US inventions or sold by US companies

Jamie Love james.love at keionline.org
Mon Jul 29 09:02:57 PDT 2013


2010 FDA (NME) drug approvals: few were based upon US inventions or sold by
US companies

25. July 2013

In any given year, the U.S. Food and Drug Administration (FDA) grants
marketing approval to new drugs. The most important category* are those
classified as "new molecular entities" or NMEs. Chen Xingzhi has collected
data on the 2010 NMEs included in the FDA Orange Book here:
http://goo.gl/W78Tbk. Some of the data are summarized below:

Among products listed in the FDA Orange Book in 2010, 15 were classified as

Among all of the NMEs, 43 patents were listed in the FDA Orange Book,
covering 12 of the 15 products.

None of the 43 Orange Book patents disclosed US government rights in the

US inventors were involved in 8 of the 43 patents, involving 4 products. In
the 4 products that had a US inventor, three had 2 or more patents with
foreign inventors, and only 1 had US inventors only.

Patents assigned to US entities were involved in just two of the products.

US companies were the sponsors of just three of the 15 products. In one of
the three, the patents were in-licensed from Belgium. In the remaining two
cases, the US company list Orange Book patents from US and foreign patent

No one year of FDA approvals is necessarily typical for other years, and
the percentage of US owned drugs is higher in other years we have examined.
But for 2010, the role of US inventors, patent owners or companies was
surprisingly small.

Note on Biologics: The FDA also reported approval of six new biologic drugs
in 2010 that were not included in the FDA Orange Book, and for which there
are no public disclosures of relevant patents. US firms sponsored 3 of the
6 biologic drugs. Of the remaining 3 biologic drugs, one each was sponsored
by firms owned by Swiss, German and French businesses.

* The FDA taxonomy of NDA Chemical Types follows
Number Meaning
1 New molecular entity (NME)
2 New active ingredient
3 New dosage form
4 New combination
5 New formulation or new manufacturer
6 New indication
7 Drug already marketed without an approved NDA
8 OTC (over-the-counter) switch
10 New indication submitted as distinct NDA - not consolidated

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.

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