[Ip-health] Note on use of Orphan Drug Act to increase price of hydroxyprogesterone caproate from $10 to $1, 500 per dose

Jamie Love james.love at keionline.org
Wed Mar 23 07:46:53 PDT 2011


As described http://keionline.org/node/1100. the FDA says "There are
no unexpired patents for this product in the Orange Book Database."

I also don't think the exclusive rights in the trials are very
important, given the many trials that others have done on the drug.
So it is basically about the Orphan Drug Act exclusivity, which was
granted on Jan 25, 2007, and which is in effect until Feb 2018.

On Wed, Mar 23, 2011 at 10:39 AM, Sarah Sorscher <sesorscher at gmail.com> wrote:
> Does anyone have updated information on whether there are any patents listed
> on Makena?
>
> Assuming there are no patents listed, is there any legal barrier to
> compounding pharmacies making and selling Hydroxyprogesterone Caproate at
> the generic price as they were doing prior to FDA approval?
>
> Even if there are no legal barriers, is there a concern that insurance
> companies will only reimburse for the FDA-approved version (thus costing
> consumers and taxpayers millions for a drug that was already paid for with
> NIH funds in the first place)?
>
> Sarah
>
>
> On Wed, Mar 23, 2011 at 8:38 AM, Jamie Love <james.love at keionline.org>
> wrote:
>>
>> Dear Gabriel, I checked with FDA page on the Orphan Designations.
>> The approved Orphan Designation is:  "To reduce the risk of preterm
>> birth in women with singleton pregnancy who have a history of
>> singleton spontaneous preterm birth."  They may have used a narrower
>> subset of patient to obtain the Orphan Status.  I am not sure what
>> other details of the process are public information.  Jamie
>>
>>
>> Generic Name: Hydroxyprogesterone Caproate
>> Trade Name: Makena
>> Date Designated: 01-25-2007
>> Orphan Designation: Prevention of preterm birth in singleton pregnancies
>> Orphan Designation Status: Designated/Approved
>> FDA Orphan Approval Status: Approved for Orphan Indication
>> Approved Orphan Indication: To reduce the risk of preterm birth in
>> women with singleton pregnancy who have a history of singleton
>> spontaneous preterm birth
>> Exclusivity Start Date: 02-03-2011
>> Sponsor: KV Pharmaceutical Company
>> One Corporate Woods Drive
>> Bridgeton, MO 63044
>>
>>
>> On Tue, Mar 22, 2011 at 1:34 PM, Gabriel Michael
>> <gabriel.j.michael at gmail.com> wrote:
>> >
>> > According to the Time article, the CDC, and a variety of other sources,
>> > there are around a half million preterm births annually in the U.S... which
>> > part of Sec. 526 [360bb] (a)(2) is being used to justify this move? The
>> > "less than 200,000 persons" provision, or the no cost recovery provision?
>> >
>> > Also note that as reported by Time, Preckshot of the Professional
>> > Compounding Centers of America gets the facts wrong: "Preckshot adds that
>> > compounding pharmacies may still be able to make a different version of
>> > hydroxyprogesterone that would not violate the patent on Makena. "There's
>> > the possibility of using different vehicles, other oils, than the one used
>> > in Makena," says Preckshot, who is also a compounding pharmacist himself."
>> > But the KEI note shows that there are no patents at issue.
>> >
>> > Gabriel
>> >
>> > --
>> >
>> > Gabriel Michael
>> >
>> > Doctoral Student
>> > The George Washington University
>> > Department of Political Science
>> > gabriel.j.michael at gmail.com
>> >
>> >
>> >
>> >
>> > _______________________________________________
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>> > Ip-health at lists.keionline.org
>> >
>> > http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>>
>>
>>
>> --
>> 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.
>> twitter.com/jamie_love
>>
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>
>



-- 
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.
twitter.com/jamie_love




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