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MComes RPH

No new update on generic Azilect...here's why

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MComes RPH    180

Hello everyone,

I have had many questions about when generic Azilect is coming out. I guess the best way to put it, now as we speak, is that just because a patent expires does not mean it will automatically go to generic. There are patent laws involved, as much as we may not like them, they are there for the brand name company to squeeze every dollar they can get.

I found 2 terms that may make this a little easier to understand. I have posted them below, but as of today, I still have the release date of ABOUT FEBRUARY 2017.

Here are the 2 terms used when it comes to patent law:

TERM DEFINITION Drug Patent:

A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.

Drug Exclusivity:

Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.

Hope this helps clear up some confusion out there.

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Deb2shoes    20

Teva petitioned and the US Patent office granted an extension to Teva's patent, originally to expire on 2/7/12,  to 2/7/17.  I read there was an unsuccessful lawsuit by a company to fight the extension. I have been taking it for 5 years and was thinking bout not retiring until 2017 in order to be able to afford Azilect.  I had heard it was so expensive in regard to the medicare "donut hole." I was assured by the person helping pick my drug insurance that will not be the case for me.  I am glad I retired now though because my symptoms (especially what I call my PD "illness") are much less without the commute and the stress from my work load.  I just retired in June and haven't yet ordered Azilect on my new prescription plan.  I will see if that person was correct.   :?  

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MComes RPH    180

I have not received any further updates on this, but when I do I will let you know. Thank you for the information.

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waruna01    44

If this statement is true, it seems likely generic Azilect will be avilable early 2017

 

"-AZILECT: Actavis, Apotex, and Orchid have settlement agreements allowing launch shortly prior to February 7, 2017. Actavis and Apotex received FDA approval for generic AZILECT on July 1, 2013 and September 12, 2013, respectively."

 

Here is where i found it.

 

http://www.google.co...9,d.cWc&cad=rja

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MComes RPH    180

I contacted the Apex/Orchid pharmaceutical company, and all they could tell me is that is the settlement date but could not confirm or deny that September is the date that the medication will be on the shelf. So it looks like I received the same info as you.

Let's hope for the best.

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MComes RPH    180

I heard sometime betweem September of this year and February of next year. But who knows. I guess we will know when it hits the shelves.

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waruna01    44

-AZILECT: Actavis, Apotex, and Orchid have settlement agreements allowing launch shortly prior to February 7, 2017

 

I thought it was September of 2016 - Feb 2017 based on the statement above. Good to hear its coming out earlier

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MComes RPH    180

I am like you. Better to hear it if coming out sooner than later. Let's jus hope that comes with à lower price tag was .

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MComes RPH    180

The 2 dates I read about, September of 2016 & February 2017, were both from drugs.com. Once again, even though a generic version has been approved by the FDA! this does not mean that the product will necessarily be commercially available to the public on those dates. This is possibly because of drug patents and/or drug exclusivity (as I mentioned in one of the answers above).

Either way, it looks like it will be soon.

Hope this helps.

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waruna01    44

If they have indeed settlement agreements allowing launch shortly prior to February 7, 2017, i think it should definitely come before February 7, 2017. Settlement agreement should allow this to happen. I wish we can find out more about this settlement agreement.

 

"-AZILECT: Actavis, Apotex, and Orchid have settlement agreements allowing launch shortly prior to February 7, 2017.

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MComes RPH    180

It is very tough to find out that exact info. Especially when the companies aren't sure.

I do see it coming between September of this year and February of next year.

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MComes RPH    180

That is the latest i have heard. Possible release date of early to mid 2016.

If i get any updates information I will make sure to pass it along.

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MComes RPH    180

Fiscal years with companies do not run in the normal 12 month cycle like our calendar.

So it would be between September 2016 & February 2017.

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waruna01    44

I heard few that Azilect has come out in generic now. Can you confirm if that is true? Is the generic available now? I wonder if the generic price is still higher since 1st generic company gets a 180 day period without competition

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