Status of Asacol generic

Now that Asacol is off patent, what is the latest on a US generic replacement?

The questionable discontinuation of old line Asacol (vs. still on patent Asacol HD) back in the spring makes me wonder what the hell is going on, particularly since I don't see an Asacol generic ready to go in the US.

This is a *strange* set of affairs considering that old line Asacol had a pretty big darn market - usually generics are *quick* to step in under these circumstances.

Leaving aside possible pharma perfidy (for the moment) can anybody clarify the US generic mesalamine market situation (which seems pretty muddled from my internet surfing).

Leaving aside the issue of encapsulation (which relates to the pH at which the mesalamine gets released and *apparently* fiddles with the patent start date/term as well...) is there *any* generic mesalamine pill *now* on the US market?

I've been relying on the Canadian market for 10+ years (Novo 5 Asa from Novopharm) but even their pricing/distribution has gone wacky over the last year.

What is going on?

Based on the circumstances as they currently appear (sudden product appearances and disappearances, sudden component concerns unspoken for 20 years, the Case of the Mysteriously Missing Generic, etc.) and some detailed reporting (http://www.bendbulletin.com/article/20130728/NEWS0107/307280363/) I think it might be time to communicate to Warner Chilcott that their team of lawyers may have been too clever by half this time.

It *really* looks like blatant regulatory manipulation (and possibly competitor payoffs) may be going on.

WC (and Asacol's prior owners) have made a lot of money off this drug during its lengthy legitimate patented life.

What is going on *now* is going to generate the blackest possible PR for the company (think Obama is fishing for pharma villains right now, to distract attention from the wheels coming off Obamacare?) and quite probably lawsuits - since WC's tactics seem so idiotically close to the line that it is hard to believe they don't actually go over.

This isn't the old days - any story can go viral in a split second (and we know how well inclined the MSM is to pharma and, say, health insurers...).

And how difficult is it for any of the over one million UC sufferers to set up a Kickstarter to fund an internet advertising campaign (wonder if the MSM might like *that* story) or an Indiegogo to initiate lawsuit financing?

WC seems so transparently manipulative here that WC shareholders may want to question the competence of their CEO.

WC looks like it is buying a little time with some *very* bad press and poisoned branding.

Quincy,

I've been using Novo-5-ASA from NovoPharm (mesalamine generic) for over 10 years (which I mentioned).

The active ingredient (mesalamine) is the same in Asacol and Novo.

The encapsulation (pH release) might be different. Perhaps Novo's is *superior*.

But all this has nothing to do with my main point.

Isn't anybody else p*ssed off that WC is playing stupid patent games (after years of legitimate monopoly protection)?

CD and UC sufferers have made Asacol rights holders *billions* during their legitimate period of exclusivity - now it is time for WC to stop the bullcrap, do something *useful*, and go back to actually *discovering* treatments rather than using the courts to game the system.

The good news for Asacol users is that the Asacol patent expired July 31, 2013.

The bad news is that Warner Chilcott is doing everything it can to prevent generic competition. This is the most likely reason why they discontinued Asacol and replaced it with Delzicol just a couple months before the patent expiration.

A very good article on this is below:
http://www.bendbulletin.com/article/20130728/NEWS0107/307280363/

I have taken Asacol for almost 20 years and it has worked very well for me. I'm glad it is there. However, I don't have drug coverage so I have paid out tens of thousands of dollars over that 20 years paying list price.

According to Reuters "Asacol contributed $743 million to the company's revenue in 2011" .

A quote from Warner CEO Roger Boissonneault “Generally, the generic doesn't even get launched because the reference product will be Delzicol," he said. “There won't be any Asacol out there. We've seen that happen with Doryx, when the generic company got the product approved. And by that time, the product had moved on ... As the reference product has changed and then moved on to either tablet or new dose form, there really isn't much to be substituted there."
Warner is being sued for it's "product-hopping" tactics with Doryx. The FTC agrees that this is an antitrust violation.

There are people suffering because of changing the formulation.
Best thing to do is alert FDA and FTC
Please send your stories to the FDA [email protected]
or the FTC [email protected]

Also, Join CCFA.ORG and be an advocate.
See my post at Forums- Treatments -"Generic Asacol".

It is time for Asacol to go generic!

shadow55 said...
The good news for Asacol users is that the Asacol patent expired July 31, 2013.

The bad news is that Warner Chilcott is doing everything it can to prevent generic competition. This is the most likely reason why they discontinued Asacol and replaced it with Delzicol just a couple months before the patent expiration.

A very good article on this is below:
http://www.bendbulletin.com/article/20130728/NEWS0107/307280363/

I have taken Asacol for almost 20 years and it has worked very well for me. I'm glad it is there. However, I don't have drug coverage so I have paid out tens of thousands of dollars over that 20 years paying list price.

According to Reuters "Asacol contributed $743 million to the company's revenue in 2011" .

A quote from Warner CEO Roger Boissonneault “Generally, the generic doesn't even get launched because the reference product will be Delzicol," he said. “There won't be any Asacol out there. We've seen that happen with Doryx, when the generic company got the product approved. And by that time, the product had moved on ... As the reference product has changed and then moved on to either tablet or new dose form, there really isn't much to be substituted there."
Warner is being sued for it's "product-hopping" tactics with Doryx. The FTC agrees that this is an antitrust violation.

There are people suffering because of changing the formulation.
Best thing to do is alert FDA and FTC
Please send your stories to the FDA [email protected]
or the FTC [email protected]

Also, Join CCFA.ORG and be an advocate.
See my post at Forums- Treatments -"Generic Asacol".

It is time for Asacol to go generic!

 

Thank you!  It is people like you that will help change things for the good of people like me. 

I never tolerated any 5ASA's period, but I feel for you all and I see that Indian pharmacies seem to sell basic asacol - indeed they probably did even before it went generic. Of course one encounters the issue of risk of quality control from some of these places but their prices are relatively miniscule to try out some. E.g. from alldaychemist.com...

www.alldaychemist.com/catalogsearch/result/?q=Asacol

Is anyone aware if any antitrust lawsuits have been filed?