UlcerGard patent... renewed? alternatives?

[JJARAB]

So I remember folks talking about how UlcerGard’s patent was up this year, so I decided to do a little research. From the document linked below, it looks like a new patent number was issued under the same application number, with the expiration now at May 29, 2021?

First Patent:
application 141-227, patent # 5,708,017 exp April 4, 2015

Second Patent:
application 141-227, patent # 6,939,881 exp May 29, 2021.

I haven’t examined the specific patents, but, generally, wouldn’t they have had to change the formula to re-patent the same product? I don’t know a lot about how that works.

On a side note, has anyone used the Abler AbGard paste? Has anyone done a 30 day AbGard followed by pop-rocks for maintenance? I don’t doubt the “power of the pop rocks” but I do like a paste idea for treatment to make sure it all gets in there.

Thanks, as always!

[Zu_Zu]

Thanks for this information JJARAB ~ appreciate knowing ~

Thanks for this information ~ appreciate knowing ~

[Winding_Down]

Anxiously awaiting news on any new distributors coming out with a copy of gastrogard. My vet told me that they have not yet been approached and I am reasonably certain they will be if someone else decides to make it. Equine is such a small market so I doubt it is of highest priority to potential distributors.

As for the pop rocks, I do NOT believe in their power as others do. They are not that cheap and, at best, I may have seen a discernible difference when giving THREE packets per day. (do not know for sure as scoping at the end was not involved) At that price, I would prefer a 1/4 tube of ulcergard which I know is effective, and contains what the label says it contains. And recent research has suggested that for treatment of ulcers, a 1/2 tube was as effective as a full tube. Rarely do you need to treat at treatment dose for a full month: in horses I have had scoped, ulcers were gone by the 3rd week. So, you can potentially treat a 1/2 tube per day, or $15 per day, followed by 1/4 tube ($7.50) per day for about two weeks.

For prevention, I have used some buffers and my preference is ranitidine, purchased through my vet or at Costco. Again, ranitidine is supported by clinical trials research and you can be reasonably certain that the label is accurate.

Ooops, got off topic. I hope we get news soon that a copy of ulcergard is available at a fraction of the price of what Merial has been charging us (which is ridiculously expensive!). I would be happy with $15 or even $20 per tube!

[IPEsq]

[QUOTE=JJARAB;8102066]
So I remember folks talking about how UlcerGard’s patent was up this year, so I decided to do a little research. From the document linked below, it looks like a new patent number was issued under the same application number, with the expiration now at May 29, 2021?

First Patent:
application 141-227, patent # 5,708,017 exp April 4, 2015

Second Patent:
application 141-227, patent # 6,939,881 exp May 29, 2021.

I haven’t examined the specific patents, but, generally, wouldn’t they have had to change the formula to re-patent the same product? I don’t know a lot about how that works.

On a side note, has anyone used the Abler AbGard paste? Has anyone done a 30 day AbGard followed by pop-rocks for maintenance? I don’t doubt the “power of the pop rocks” but I do like a paste idea for treatment to make sure it all gets in there.

Thanks, as always![/QUOTE]

Those aren’t correct application numbers…not the right format, so I looked up the patents.

App. 09/867,285 led to Pat. 6,939,881, filed in 2001, issued in 2005 with no patent term adjustment.

This is a method patent for the “method for preventing occurrence of gastric ulcers in a horse about to undergo stress that causes gastric ulcers and prior to occurrence of a gastric ulcer condition in the horse, comprising administering to the horse an effective amount of omeprazole prior to, and optionally during, the stress.”

App. 08/416,275 led to Pat. 5,708,017, filed in 1995, issued in 1998. This patent covers the composition of GastroGard/UlcerGard and similar.

I’ve mentioned on here in another thread that the method patent is troubling because horse owners and vets practice the patent every day when they give a horse UlcerGard. Nonetheless, I don’t think that the '881 patent would necessarily block someone making a generic.

It is important to note that Merial filed a PCT application and obtained patents in Canada, the Czech Republic, EU, South Korea, and New Zealand, and I believe those are going to be active until March 29 of next year (2016).

[JJARAB]

I just realized I never linked the document I looked at, which was from FDA.gov:

http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/UCM042861.pdf

[IPEsq]

Those are FDA application numbers, not patent applicaiton numbers. You’ll see that the patent numbers for GastroGard (FDA App 141-123) matches the patent number for UlcerGard. The method patent refers to basically the label use of UlcerGard (for administration as a preventative).

Drug law gurus would know more than me (I just dabble in non-drug patents from time to time), but I believe the document just uses that to demonstrate what constitutes the approved administration instructions and doesn’t necessarily mean that UlcerGard as a compound is going to be covered under patent until 2021.

[JJARAB]

IPEsq - I finally saw the link below (in “similar threads”), as well, where you and ToTheNines were discussing the validity of the patents, etc. I almost wish we’d have a pinned post on how this develops. It’s a big deal for a lot of people.

[IPEsq]

I just bought a 30 day course of GastroGard…it’s a big deal for me too :winkgrin:

[Winding_Down]

and I just bought 12 tubes of ulcergard. Ouch. The only reason I did not purchase more is that I am hoping that there will be a less expensive alternative on the market soon. My vet says that their clinic has not yet been approached by other companies…

Anyone hear anything hopeful out there?

[sid]

I mentioned this to my vet…not contact about the patent expiring. He didn’t even know about it. And he didn’t just fall of the turnip truck.

[HiJumpGrrl]

It usually takes about a year for prices to drop on drugs that come off patent.

[rcloisonne]

Don’t know much about the patent situation but don’t expect the price of a generic to be that much less. I had been using Prilosec OTC (also manufactured by Merial) for years. When the generics came out, the cost was only a few dollars less than the brand name, unfortunately. I now get the stuff with a prescription from my GI guy for the insurance copay price.

Not sure what the reference to “distributor” in the OP means but a manufacturer is still needed. This manufacturer would still need to apply to the FDA to be able to legally sell a generic version.

Based on actual testing by the FDA, Abler’s paste omeprazole (Abgard) is slightly stronger than Gastrogard but within allowable +/- limits for generic drugs. The only thing wrong with it is it’s illegal as it violates Merial’s patent and Abler is not an approved manufacturer.