When will my patent-expiring drug be generic?

November 12, 2010 11:17 AM

Zyflo is a drug that makes my nose and lungs work better. It's currently ridiculously expensive, but the patent's running out. How can I find out when someone will make it generic?

Here's the deal: I have a condition called Samters Triad, or Aspirin triad. It's asthma, aspirin sensitivity, and nasal polyps. It's a huge pain in the ass, but this particular drug, a leukotriene inhibitor, works really well for me. Much better than the closest thing, Singulair. Earlier this year, the company adjusted its pricing upwards to around $650 a bottle. So I'm possibly looking at a hefty additional layout next year for this stuff. (I have an RX plan now, but won't have a very good one next year)

However -- the patent on the molecule, Zileuton, expires December 9, 2010. The current formulation has an additional patent because it's extended release, but I don't think this alone would preclude someone from making the standard release version.

The company's yearly filing states:

In addition, although we own or exclusively license United States patents and patent applications with claims directed to the pharmaceutical formulations of our product candidates, methods of use of our product candidates to treat particular conditions, delivery systems for our product candidates, delivery profiles of our product candidates and methods for producing our product candidates, patent protection is not available for composition of matter claims directed to the APIs of any of our products or product candidates other than ZYFLO CR, ZYFLO and FACTIVE. The composition of matter United States patent for zileuton that is used in ZYFLO CR and ZYFLO will expire in December 2010. The composition of matter United States patent for gemifloxacin mesylate that is used in FACTIVE will expire in April 2017.

When the composition of matter patent for the API in one of our products expires, competitors will be able to offer and sell products with the same API so long as these competitors do not infringe any other patents that we or third parties hold, including formulation and method of use patents. However, method of use patents, in particular, are more difficult to enforce than composition of matter patents because of the risk of off-label sale or use of the subject compounds. Physicians are permitted to prescribe an approved product for uses that are not described in the product’s labeling. Although off-label prescriptions may infringe our method of use patents, the practice is common across medical specialties and such infringement is difficult to prevent or prosecute. Off-label sales would limit our ability to generate revenue from the sale of our product

So far, I've a) googled extensively and found nothing, b) searched FDA's ANDA approvals and Orange Book and found nothing, and c) listened to the company quarterly results conference calls for the past two quarters. None of these things hint at any impending generic release. The rep on the conference call talks rather eagerly about the 2011 allergy season.

What else can I do to see if anyone's thinking of making this stuff? Would no one try for it because of the use patents? Should I expect a price decrease to preemptively disincentivize generic competitors?

posted by condour75 to health & fitness (9 answers total)

Well, we buy some drugs from Canada because, well, we can pay $28 and get a drug that costs us $400 here.

I just looked that one up, and even in Canada it's not generic yet, and it's $611 for 120 pills. Ouch. I guess that isn't much help to you, but in my experience, items usually hit the canadian generic realm waaaaaaaaay before the US one, I think b/c the patent window is much much smaller.
posted by TomMelee at 11:34 AM on November 12, 2010

Did you ask your doctor and your pharmacist? They know these things. Talking to a pharmacist is free.
posted by chairface at 11:52 AM on November 12, 2010 [1 favorite]

You got my curiosity up. So here's two examples

Effexor
Patent expiration
Generic availability

Claritin
History

The Claritin link is probably most interesting since it's fairly common example of what happens. The drug goes off patent so the company develops either the metabolite or other chemical tweak that is essentially the same thing but can be patented. However, the cost means generics are usually available very quickly. Claritin is a bit special since it went OTC as well so insurance stopped covering it.
posted by chairface at 12:01 PM on November 12, 2010

As of right now, it's not available generic, as you know. I'm a librarian at a school of pharmacy (so I have access to most of the things your pharmacist or doctor would use to look this stuff up) and I'm having trouble finding any news about a generic version. A doctor who prescribes this drug a lot might know more.

I would guess it's going to go generic, because this is something you take daily, right? Drug companies (including generics companies) love drugs you have to take daily. Unless there's some real difficulty in making the molecule or in proving bioequivalency (that the generic formulation really works the same as the original), there will probably be a generic on the market sooner rather than later.

There are some business databases that specifically deal with this subject but I don't have access to them - Espicom Generics Business Online, IMS Generic Market Analyzer, Newport Horizon products, and Thomson Pharma Generic Competition Module. If you know someone who has access to one of these, you might be able to get more info.
posted by mskyle at 12:11 PM on November 12, 2010 [3 favorites]

I sometimes search the message boards on CafePharma.com when I want gossip on upcoming drugs. Its basically a site where pharmaceutical sales reps have bitch sessions about their employers and sometimes talk about drugs going off-patent, new competition, etc. I tried to do a quick search for you but I'm pretty busy this afternoon. You have a wade through a lot of BS but you never know what information you might find. Good luck!
posted by halseyaa at 12:21 PM on November 12, 2010

I guess that isn't much help to you, but in my experience, items usually hit the canadian generic realm waaaaaaaaay before the US one, I think b/c the patent window is much much smaller.

No, the patent term in Canada is (essentially) the same as the US: 20 years after filing. Now, the US term is usually adjusted by about a year because of US Patent Office delays, and I don't think the Canadian Intellectual Property Office has an analogue to that, but that's not a huge difference (~5%).

There are some other possible explanations. It's possible that the Canadian TPD is faster at handling AND Submissions than the FDA is at handling AND Applications. I don't have statistics on that handy.
posted by jedicus at 12:31 PM on November 12, 2010

Thanks so much for the help, everyone -- to answer some questions:

I believe the reason the drug is the same price in Canada is that it's only approved in the US (it caused liver toxicity in some people, and for a non-emergency asthma drug with similar alternatives, that probably seemed an unnecessary risk) I think the Canadian pharmacy sites just buy it from the US if someone in the US orders it. But I wouldn't be surprised if it gets approval in Canada, because it turns out to be one half of a really promising regimen for a particular kind of leukemia.

I've talked to my doctor about this a little. She had no idea how expensive it was when I first brought up the price increase. Every time I go in, she gives me a few weeks worth of samples, so that'll help in the interim. I think a next step might be to ask her to ask the rep for some clues. I haven't talked to a pharmacist, but I know they've been helpful in the past about this sort of thing, so I may give that a try as well.
posted by condour75 at 1:56 PM on November 12, 2010

A lot of drugs have coupons available from the manufacturer to help with copays. Copay cards are super skeevy, but I'd look into it. If google turns up nothing I'd still call the manufacturer and see if there's a copay card available.
posted by pjaust at 2:26 PM on November 12, 2010

Yeah, they do copay cards. But this stuff's on no one's formulary, and even on the insurance I have now, which is really good insurance, the insurance company has balked at paying the whole thing and does like a percentage. They still take off about 30 bucks for the copay card though.
posted by condour75 at 3:17 PM on November 12, 2010