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Old 12-14-2006, 04:32 PM #1
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Default Can't get generic Plavix

Hi All.

Alan takes plavix ever since he got the stent in January. Well, about two months ago, Alan began taking the generic equivalent and there was no problem.

Well, he just came back from the drug store and was told that they can't dispense any generic plavix because there is a problem with the patent.

Then I went online and just read the following:

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FBI agents raided the office of Bristol-Myers Squibb Co. CEO Peter Dolan, as the Justice Department opened a criminal investigation into the company's deal to delay the launch of a generic version of its best-selling drug, Plavix.

The company is allegedly paying a Canadian company not to produce a a drug similar to Plavix. BMS confirms that it is the target of a Justice Department probe, which will determine whether laws have been broken. It provided no other details.

The unique circumstances revolve around the patents that BMS and its partner Sanofi hold on Plavix. Canadian drug maker Apotex is challenging those patents and was poised to launch its copycat version of Plavix in the next few months.

Earlier this year BMS and Apotex reportedly agreed on a deal for Apotex to suspend its legal challenge to the Plavix patents.

In return, it would receive permission to launch its generic version of Plavix a few months before the patents expired. For the agreement, Apotex would receive a cash payment from BMS.

At first the Federal Trade Commission objected to the terms, forcing the two sides to renegotiate portions of the agreement. Consumer advocates, however, were outraged at the deal, saying it's illegal and will end up keeping drug prices high.

The Justice Department investigation will determine whether the deal, is in fact, legal or not.

If it finds that it is not, industry analysts say it will be a significant blow against large drug makers, who have seen small generic competitors make significant legal inroads against patent protections in recent years.

These same analysts say, however, that striking down the deal would continue a trend that has resulted in steadily lower drug prices for insurers and government.

Plavix, a blood-thinner, is BMS's most profitable drug. It produced $2.1 billion in revenue in the first six months of this year.
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ANYBODY KNOW ANYTHING ABOUT THIS????

Alan can't be the only guy on these boards that uses plavix!!!

Melody
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Old 12-15-2006, 10:28 AM #2
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Lightbulb this is a huge topic

and I first heard it over the summer on the radio.

We still have generic Plavix at the nursing home provider. But independent
pharmacies may no longer have it. I think, but don't quote me, that the
generic is allowed to be dispensed until it is used up. There is no recall in
place.

http://patentbaristas.com/archives/000458.php
and
http://www.npr.org/templates/story/s...toryId=5630796

Basically my take is that when the new information about the stents came out,
Bristol-Myers realized a huge larger market for Plavix. The recommendation is
that stent patients use anti-coagulation therapy for LIFE. Plavix is a huge,
money maker for them, their main one after Glucophage went generic. They will fight to keep $$ flowing in with Plavix.

Here is a quote about "availability":
Quote:
Nebraska Medicare Prescription Drug Coalition
COALITION RESOURCE PAGE

Coalition Home | Member Page | Conference Information | FAQ | Community Events Calendar | Enrollment Assistance Tools | Resources | Consumer Alerts

Note to Ship Programs and the Aging Network:
Clarification on the Availability of Clopidogrel (Generic Plavix)

Clopidogrel, the generic version of Plavix was originally released during the summer of 2006; however, the generic was removed from the market a short time later because of a patent dispute. Many pharmacies received supplies of Clopidogrel before the patent dispute came up and thus had a supply of the drug that was being dispensed to some individuals over the past couple of months even though the generic isn’t really available in the marketplace.

The Reference NDC list (master list of drugs) does not currently have Clopidogrel listed as an available drug and this list is used to derive the drug look-up list on the drug plan finder. Once the generic is available on the list, it will be added to the drug look-up list on the drug plan finder.

In the meantime, plans can cover Clopidogrel; however, they must continue to cover the brand drug, Plavix under their plan’s formulary and at the same tier level. They are not permitted to discontinue the coverage of Plavix, they cannot change the tier level, and they cannot change the utilization management for the drugs (e.g. they cannot add prior auth, step therapy, or quantity limit requirements for the drug).

Last Modified - December 4, 2006
from http://www.answers4families.org/medicare/plavix.html

Where I work now we use enormous amounts of generic Plavix. I oversaw
hundreds of repackaged blisters on Sunday alone. I'll let you know Melody when we no longer have it. It will probably be soon. (where I work we repackage all loose tablets into 30 count blister packs..it is an enormous job, and one that I oversee occasionally when I work there).
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Old 12-15-2006, 12:12 PM #3
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Default Mrs D, this is interesting....

does this mean the generic is being repackaged into the brand name packs?THAT can/must be truly scary!

IF a generic is identical it should be no problem...but some generics vz brand names do have noticable differences in either quality controls or processing control issues.

A good example would be synthroid. My docs have always insisted on the brand name, and if I recall my readings correctly this is one that's justified. Others? I'm not so sure about.

All a doc has to do is check to off the box to not substitute for generic. OR not check off any box at all, in which a generic will be provided.
All said tho, for so many the co-pay is the bigger issue.
A real catch-22 in our society and a problem core to medical, insurance, and pharmacies goals, all in conflict with each other.

I think this would be a good rolling topic for all to discuss. As there are many instances when it's good and not..Costs aside. To me, the proof is efficacy regardless of costs. But, that's just me. Maybe a poll?

The most absurd aspect I've found is when docs check off 'generic OK' or don't specify, meaning a generic can be used... KNOWING there is NO generic. Kinky, actually.

Mel, sorry to get off your subject here, mainly: Alan. But, your post does bring up an important issue for all of us who come here. - j
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Old 12-15-2006, 12:37 PM #4
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Ooo oh, no...

When working with nursing homes, assisted living, there are times when drugs are returned. Loose tablets cannot be returned. Each blister cell has the lot # manufact, exp date, etc. This also avoids errors in giving the medication since every pill is LABELED. Nothing is changed or substituted, just repackaged for convenience and safety. We don't do every drug..most (about 70%) come from our parent facility which is a huge manufacturing (FDA approved) facility.

Where I work we provide service for the whole state. It is HUGE...this operation.

We purchase drugs in the largest wholesale package available and repack them into blisters of 30. These can be cut up, or handled any way necessary by
the nurses. The drugs are put into amber and air tight foil. Our repack room is basically for low volume drugs or "shorts", things we run out of. Still it is a huge task.

Brand Plavix comes in 30 ct and 90 ct bottles. Loose tabs. Even those, when we do use them are repackaged. However, the Apotex brand comes in huge bottles of a 1000 (or it might have been 500-- I can't recall).

The only things we do not repackage
are tablets that are HUGE like Fortamet, and Fosrenol, or Nifedipine XL90.
We don't have "cells" large enough for these.
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Old 12-15-2006, 03:40 PM #5
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Default Please don't think I'm stupid but?????

What exactly does this mean?

Will we be able to get generic plavix eventually???? or not at all?

Thanks

Melody
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Old 12-15-2006, 11:37 PM #6
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Red face What this means to you and Alan,

is that not in the near future...nope.

Bristol-Myers will have the court date in the spring, but I suspect they will
win. And brand will only be available. Money talks, and the drug companies
usually win, on patent claims.

There might be regional availability issues. The wholesaler we use, has
estimates of our high need, and likewise holds items for us. You are in another
part of the country, and existing supplies of the generic may be gone, for smaller typical pharmacies.

I no longer have access to the sales reps for the wholesalers, like I used to,
so I am limited in answering this question. Alot depends on how many of the generic units were purchased/stored. Each drug chain does this differently. So it will vary, in how fast it is gone.
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Old 12-16-2006, 07:58 AM #7
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Default Thank You Mrs. D

Alan is taking me out to breakfast. That always puts me in a dancing mood!!!
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