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Q: Drugs coming off patent by year ( Answered 5 out of 5 stars,   1 Comment )
Subject: Drugs coming off patent by year
Category: Health > Medicine
Asked by: ianfuller-ga
List Price: $10.00
Posted: 03 Oct 2002 10:12 PDT
Expires: 02 Nov 2002 09:12 PST
Question ID: 72072
I'd like to find out the dates of expiry for the US and international
patent protection for branded drugs (e.g. the statin drugs for
lowering cholesterol). Is there a central source for this information?
Subject: Re: Drugs coming off patent by year
Answered By: rbnn-ga on 03 Oct 2002 11:05 PDT
Rated:5 out of 5 stars
This information is available for free from the FDA, called the FDA
orange book, at . However,
it is not easy to use directly (although a simple perl script can
massage it into a form you want); one must download an executable
which unzips several files and the patent information is cross-indexed

Specifically, I downloaded
which, when run, created files including APPROVED.TXT and PATENT.TXT
whose format is described at the above web page. For instance, one
learns from APPROVED.TXT that

BASE/5ML~074973~001~~JAN 24, 2000~Yes~RX

that is, the drug Trimethorprim hydrochloride in solution with oral
administration named Primsol by Ascent Peds with the strength given
has New Drug Application Number 074973 and was approved Jan. 24 2000.
Checking the file PATENTS.TXT we see the lines:

074973~001~5763449~AUG 07,2016~
074973~001~5962461~AUG 07,2016~

which indicates that the drug, under the two patent numbers cited,
expires Aug 7, 2016.

For individual drugs the FDA has a searchable database at: ; one can search by active ingredient,
proprietary name, applicant holder or application number. However,
there does not seem to be a way from there to get specific expiry
dates of all drugs. Their page: does contain pointers to New
and Generic Drug Approvals
and however.

For more convenient searching, there is also
the MyOrangeBook database: claims to

"Complete access to the FDA Center for Drug Evaluation and Research's
Information on Approved Drugs and Drug Products, indexed by:

Date of Patent Expiration 

Date of Exclusivity Expiration 


Ingredient / Generic Name 

Trade Name 

This costs $25.00 however.

There is a book available, "Drugs under patent 2002"  that has this
information at:

The Thomson Dialog "IMS Patent Focus" at has this
information, "compiled using IMS Health International databases, in
addition to original patent specifications, patent office journals,
and additional secondary sources of patent and chemical information."
I don't think the site itself looks like it suits your needs, but there
indicates some of the many sources they index.

IMS Health, , offers several drug reports,
including information on specific drugs in development,
; however, I did not see there a specific list of expiring patents.

The site: contains lists of
databases on patent and other ip information; again, these do seem to
be pay sites. For example,

"Drug Patents 2001 is a reference tool based on the statistical
analysis of patents in the pharmaceutical and biotech field. The
information and indexing is drawn from the last five years of Current
Drugs' Patent fast alert, supplemented by detailed bibliographic data
from INPADOC. There are more than 47,000 patents in the five-year
analysis, including some 8,000 published during the year 2001"

but at a cost of about $800.

Orange Book Patents  atl offers a
book for $400
representing a compilation from "seven different sources" although
they do not specify what those are. They do offer a money back
guarantee, however.

Search Strategy:

I did a google search on 

 drug patents expiration

which led to numerous orange book citations.

I perused the FDA websites and also did a search on 

 FDA orange book

which led to the above database. I downloaded and unzipped the
database in question.
ianfuller-ga rated this answer:5 out of 5 stars
That saved me a lot of work. Thank you very much.

Subject: Re: Drugs coming off patent by year
From: rbnn-ga on 03 Oct 2002 10:15 PDT
I only found this information in a pay site; I haven't found it available for free.

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