FDA- Horse supplement warning

[Simkie]

[QUOTE=SuckerForHorses;7853491]
According to this document: http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm117173.pdf

GastroGard US Patent 5708017, Expiration April 4, 2015[/QUOTE]

Yes! Yay! Who is planning a party next April?

Ulcergard has the same patent numbers on the box as Gastrogard, but there is actually another attached to it that expires much later. Let me see if I can turn it up…

Ah-ha. It’s this one:

http://www.google.com/patents/US6939881

I’ve only seen it on this document from the FDA, not on any of the literature from Merial.

[URL=“http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/UCM042861.pdf”]http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/UCM042861.pdf

It will be very interesting to see if anyone comes out with a generic. The market has well shown that people will purchase the snot out of something that costs less.

[Texarkana]

[QUOTE=SuckerForHorses;7853491]
According to this document: http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm117173.pdf

GastroGard US Patent 5708017, Expiration April 4, 2015[/QUOTE]

Thanks for that link! But you didn’t quote the entire line. I used the wrong word in my previous post-- it’s not the patent that prevents generics, it’s the exclusivity. You learn something new every day! From the link above:

Under Section 512©(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act, this approval
qualifies for FIVE years of marketing exclusivity beginning on the date of approval
because no active ingredient (including any ester or salt of the active ingredient) has been
approved in any other application.

Patent Information: US Patent 4255432, Expiration April 5, 2001; US Patent 5708017,
Expiration April 4, 2015.

Their five years of marketing exclusivity have passed, since the initial approval was in the early 2000s.

Anyone has been legally able to make GG for several years. I just don’t know why no one has…

[Texarkana]

I googled: Ulcergard’s exclusivity has run out too. They had three years of marketing exclusivity from the date of approval, which was 2004.

http://www.fda.gov/downloads/animalveterinary/products/approvedanimaldrugproducts/foiadrugsummaries/ucm118038.pdf

Dang people need to make some generics! What’s the hold up?

[Simkie]

Marketing exclusivity is different. You can’t make a generic until the drug comes off patent.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm

[Texarkana]

[QUOTE=Simkie;7853558]
Marketing exclusivity is different. You can’t make a generic until the drug comes off patent.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm[/QUOTE]

Ah… but I’m still a little unclear-- so both patent and exclusivity need to expire in order for a generic to be made?

Why do we have any generics then? Why wouldn’t a company just continue reapplying for a patent year after year and keep the market cornered? (These are somewhat rhetorical questions…)

Because in 2015, I guarantee Merial will apply for another patent on both GG and UG. Is there something that would prevent them from receiving one?

[Simkie]

Once something is patented, you can’t reapply for the same patent. So you get your 20 years. What drug companies DO do all the time, though, is change something very minor, get the new patent, and push their “latest and greatest” drug at the premium name brand price.

Marketing exclusivity, from what I understand, is useful when a company developed and patented something 25 years ago, and shelved it for whatever reason, but new demands/developments make it a good thing to bring to market. Without some promise of exclusivity, there is zero motivation to bring it to market.

You can also get exclusivity if you take two FDA approved drugs, combine them and prove they can do something.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm

(I don’t know a whole lot about exclusivity, so hopefully I’m not just totally wrong here. But I do know 100% that you cannot produce and market a generic until the patent has expired.)

[Texarkana]

Gotcha! Thanks for the info, Simkie!

[vineyridge]

I personally would think if anyone challenged the Ulcergard patent it wouldn’t stand up. There is nothing original about using a small dose of an effective drug as a preventative.

[Simkie]

That patent isn’t even on the box, Viney, so I don’t know if Merial cares about it. I turned it up accidentally, looking up Gastragard info. I’ve never seen it cited or mentioned anywhere but that FDA doc I linked earlier.

Ulcergard is still protected by the same patent as Gastrogard. I am curious to see if Merial considers UG “off patent” in April.

[SuckerForHorses]

What I want to know is:

What exactly does someone like Abler need to do to continue selling to us???

Just remove the claims of “treating” ulcers?

[Simkie]

[QUOTE=SuckerForHorses;7853794]
What I want to know is:

What exactly does someone like Abler need to do to continue selling to us???

Just remove the claims of “treating” ulcers?[/QUOTE]

It’s not legal for them to sell omeprazole at all in the US, I don’t think. Drugs have to go through the FDA and meet approvals. They haven’t done that.

And no one can sell omeprazole for horses except for Merial until the GastroGard patent expires.

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm

[naters]

In case anyone else was looking for the original link.

I see their point, but the pharmacy industry is so stuck to the FDA that I don’t trust either, really.

http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm422694.htm

[Laurierace]

Well, my question is does warning mean the same thing as forcing them to stop? Should I place another order of pop rocks even though I don’t need any right now? Interesting that they were stronger than they were supposed to be because I cut my horse down a pack as a treatment dose and he still did fine. I guess because he was still getting enough.

[joiedevie99]

[QUOTE=Simkie;7853872]
It’s not legal for them to sell omeprazole at all in the US, I don’t think. Drugs have to go through the FDA and meet approvals. They haven’t done that.

And no one can sell omeprazole for horses except for Merial until the GastroGard patent expires.

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm[/QUOTE]

I don’t believe that’s correct. Omeprazole is already a generic drug. Merial’s patent is not on the omeprazole, it is on the delivery system that gets it through the horse’s stomach to where it needs to work. If another company wanted to sell omeprazole, they’d have to find some other way to buffer it - then get FDA approval.

[Simkie]

[QUOTE=joiedevie99;7853937]
I don’t believe that’s correct. Omeprazole is already a generic drug. Merial’s patent is not on the omeprazole, it is on the delivery system that gets it through the horse’s stomach to where it needs to work. If another company wanted to sell omeprazole, they’d have to find some other way to buffer it.[/QUOTE]

Oh, I might be thinking about the protection against compounded forms of omeprazole for horses. When that first started happening, there was a lot of conversation about the legality of that…and I think the consensus was that it’s not legal, because there is a preparation out there (GastroGard) that’s readily available.

I bet you’re right–if someone wanted to do all the work to get a novel delivery system through the FDA, then we’d have two options. But Abler hasn’t done any of that work, so it’s still not legal…

I wonder if Merial will release esomeprazole in a paste formulation next year, and tell us all how much better it is than Gastrogard? Keep the gravy train rolling?

[Texarkana]

Adding my little bit of knowledge from working in both veterinary and human medicine:

Merial’s patent is on their proprietary omeprazole compound for use in equines.

No one else (to my knowledge) has gone through the process to get omeprazole approved for use in equines.

No one else can legally sell similar omeprazole pastes labeled for use in equines while Merial holds the rights, with the exception of compound pharmacies who may compound it into their own product per doctor’s orders. I thought Merial’s rights to it were up, but have since been corrected.

The whole “enteric coating” thing on pop rocks may require Abler to submit an entire new drug application regardless of Merial’s patent, since it is a slightly different delivery method. The new drug process is expensive, and can that takes months or years to complete if they wished to pursue it. But I would love for someone in the pharmaceutical industry to actually weigh in on whether or not they’d need to submit a new application, since I’m basing my assumption on my prior pharmacology experience.

[CindyCRNA]

FDA approval does not equate to efficacy or safety. It’s all about money. FDA approved drugs do not make me feel any safer. It would be nice to know that if a drug says it contains “A”, I would like it to contain “A”. I love how the article stated 111% is “SUPER POTENT”. Considering the dose range for propylaxsis vs treatment, I’m just happy it contains at least as much as it says it does. We are talking ulcers. Not blood thinners, not blood pressure medicine. The FDA is not worried about horses.

[IPEsq]

I don’t think that Abler’s product necessarily infringes upon the Gastrogard patent rights. Assuming for argument that it doesn’t, Abler still needs to seek FDA approval even if the pop rocks are considered an OTC drug (not requiring veterinarian prescription) under the FDA guidelines for OTCs and products containing active pharmaceutical ingredients.

The FDA really doesn’t care a whole lot about the patents. What it does care about is making sure that each package of the drug meets certain quality control standards like meeting the drug strength as labeled, in every single package. I believe the issue is that omeprazole is a drug versus something like an herbal supplement that falls under FDA regulatory authority.

The patent issue is more of a fight for Merial to fight if it considers Abler’s product to be infringing. The “offering for sale” of products into the U.S. is enough for that if Merial were to think that the pop rocks or any other omeprazole compound for equines are infringing. But again, that is separate from the FDA issue.

[bambam]

The abler letter says that it is both more of the drug than labeled and that it is adulterated. The adulterated part worries me more than the % issue. Adulterated how and with what I wonder?

[SuckerForHorses]

[QUOTE=bambam;7857566]
The abler letter says that it is both more of the drug than labeled and that it is adulterated. The adulterated part worries me more than the % issue. Adulterated how and with what I wonder?[/QUOTE]

The FDA is calling it adulterated BECAUSE of the amount discrepancy issue.

In addition, the drug AbGard is adulterated under section 501© of the FD&C Act [21 U.S.C. § 351 ©], as testing of the drug revealed that its strength differs from the strength stated on the label.