Generic Insulin

I’m on two different kinds of insulin, and the cost really adds up every month. Does anyone know if there is a generic version of the Novolog and or Lantus flex pens? Any help would be so greatly appreciated! I saw today that some times, you can purchase test strips off of eBay? Has anyone tried this? I’d love to uncover some new ways to save money.

Thanks!

Ashley

There aren’t generic brands of ANY insulin yet. Because insulin is considered a biological pharmaceutical, the rules for it are different. Though these rules are being addressed right now, and we may see generic insulins eventually.

Insulin delivered by syringe is generally cheaper than insulin pens, so that might be one way to save money if you’re willing to switch.

All modern analog insulins are patented by the respective company. So it will take a while until generic versions can be produced (more than 10 years I guess).

Hi Ashley:

Mollyjade speaks the truth – no generic insulin available in the US. One thing you could try is asking your endo for a sample pen or two. I’ve been able to do this through my endo, and always manage to walk away with at least a couple of pens and needles; they may even be able to give you samples of strips depending on what meter you use.

I am just speculating, but I think part of what the first responder was so graciously trying to say is that he’s never been so desperate as to purchase strips off eBay. It may be a cost savings to you – but “Buyer Beware” should be your watchword. Maybe you could find some other area of expenses to curtail, rather than gambling with testing supplies of unknown origin?

(Do you have insurance coverage? Mail order strips might cost less.)

-vicki

Buying and selling prescription items (test strips, for example) off of eBay is frowned upon, but I’m not sure if it’s actually ‘illegal’ or not. So while there may be some good deals, I don’t know if it’s consistently the ‘best’ bet for you to count on.

And @Mollyjade, recently some insulin manufacturers are actually making it more costly to just buy 10mL vials than to buy pens of the same amount (I think it’s a marketing push to sell more pens, but that’s only my speculation).
That being said, Ashley you may want to look at the cost of a box of 100 pen caps and insulin pens for ‘x’ amount of days compared to 100 needles of your choice w/ the same amount of insulin…and see what works out to be cheaper.
Sorry that I don’t have any better ‘magic button’ advice to make it drastically less expensive :frowning:

“Generic drugs” are drugs that are sold beyond patent protection and are usually referred to by the drug chemical name rather than a brand. When Banting and Best first developed insulin they made a specific decision to not patent insulin. And when they made agreements for their production with the drug companies of the time, they demanded that insulin be made available without prescription. While at the time, it was a heroic move, it left today’s insulin market totally messed up. Technically, all human insulins are “generic” but they are all still branded. The modern analog insulins (including novolog and lantus) have been modified and the developers took out patents to protect their products. These modern insulins are all branded, are under patent protection and require a prescription.

Older insulins such as R and NPH are human insulins, not protected by patent and are technically “generic,” but you won’t save any money as they are still branded and “relatively” expensive. Why? Cause the insulin business is basically just not very profitable. Nobody can make a business making a medical grade insulin for $1/vial and selling $5/vial “Joes XXX Generic Insulin.” There is just too much overhead in the medical supply business. That being said, Novo Nordisk does sell a cheap “brand” of their insulins, it is called Relion R and NPH (and mix) which is available for $24/vial. This insulin while “branded” is not protected by patent and is a quarter of the cost of novolog and lantus, it just does not perform as well.

Hope I have totally messed up the issue.

There is some mistaken information in this conversation; insulin is technically not considered under U.S. law to be a biotech drug, it is governed by the Federal Food Drug and Cosmetics Act which governs small-molecule drugs and the Hatch-Waxman Act rules still apply, but generic versions of first-generation biosynthetic insulins aren’t yet available for a number of different reasons. Analogues are patent-protected, but the patents on Humalog and Novolog are due to expire less than 2 years from today. I would encourage everyone to read my groundbreaking blog post on generic insulin here for more information on this subject. The CEO of Medco Health recently told a reporter that he expects generic (e.g. “follow-on” in FDA parlance) insulins to emerge by 2013, and generic analogues for Humalog and Novolog to emerge by 2015. You can read the Medco CEO news story here. Until generics emerge, you absolutely should be asking your doctors for free samples; the manufacturers and their salespeople give this stuff to the doctors and there’s no reason why you as a needy patient shouldn’t have it!

You may want to check out the manufacturers websites as well.

What is the mistaken information? I believe any proposed generic insulin would still need FDA approval, right? Although you don’t have to do trials you have to show that it is the same and prove the safety of the product and you still have to do the paperwork. Given that you can already get Relion for $24/vial, do you really think there will be any future “generic” that is cheaper? Forgive me for being dubious that there will be a $4 walmart generic insulin anywhere in the near future. None of the existing producers of insulin want to see a generic form, it will destroy an already poorly profitable market for them. And make no mistake, if we are left with only older generic forms of insulin and no continued development of new insulins, that will truly be a shame.

In my view, the whole insulin industry is a broken business. The value to society of insulin is already much greater than the value of the insulin being sold and now we want to further reduce the money spent on insulin. But this is misguided, what we want to do is reduce the cost to the patient, not make the insulin busines a $100M market with no research and drivin off-shore to the cheapest manufacturer. There is a compelling argument for greater government involvement, supporting the healthy industrial base producing insulin and providing ongoing funding towards developing improvements insulin.

On for a few minutes waiting for another meal to pack for camping, but wanted to let you know to do some comparison shopping among pharmacies as well. I can get Novolin R at Wal-Mart pharmacy for $20.00 per bottle and it is a brand manufactured by Squibb-Novo specifically for Wal-Mart called Reli-On. Other pharmacies do not have it, just Wally World. The insulin is the same as Novolin R with the same absorption rate and reliability. I’m not ashamed to use it and will pay $20 as opposed to $45.00 for Novolin. I have never asked about the logs though. Sometimes drug manufacturers will work with people too if you actually write them a letter, not e-mail them. Give them you phone number and have them call you to see what they can do for you. The worst they can say is “Sorry, we can’t help you.”

The errors are that if a manufacturer sought approval for a follow-on version of regular, NPH or the Lente series, the manufacturer could apply today using Section 505(b)(2) of the Federal Food Drug and Cosmetics Act. That means, while it still requires FDA approval, unlike a regular NDA (new drug application), this would be an NDA for a modified form of a previously-approved product. Because of this, the manufacturers are not required to submit brand-new clinical trial results for it, but can rely on the original clinical trial results submitted with the original drug. That is a significantly faster review process than what a regular NDA under Section 505(b)(1) requires. In addition, under section 505(b)(2) of the Federal Food Drug and Cosmetic Act, a generic doesn’t have to be an exact duplicate of the brand-name original in order to be approved by the FDA.

On the cost discussion, the margins for insulin have steadily increased since analogues were first approved in 1996; in fact, the profit margins on insulin exceed those of testing supplies (most insurance companies get huge volume discounts on testing supplies), if that tells you anything, and manufacturers have aggressively raised prices in insulin in recent years, largely because they can get away with it because there is no generic competition. For your information, insulin is a $12 BILLION business – significantly larger than the figure of $100 million you cite. Humalog is one of Lilly’s biggest, most profitable businesses, and the Humulin business generates income of over $1 billion per year – that’s hardly a low-margin business. As to whether it is being driven offshore to the cheapest manufacturers, to a large extent, that is already happening. Lilly outsources the manufacture of all insulin vials sold in the U.S. to Hospira, Inc. (insulin pens and cartridges are still made at Lilly’s own factories in Puerto Rico and France), and Novo Nordisk recently expanded its Brazilian operation with the expectation that they would not be significantly expanding their North Carolina manufacturing, rather any excess capacity for insulin products would be made in Brazil. Although Hospira makes the stuff for Lilly in Kansas, there’s nothing stopping the company from shifting to an Indian manufacturer with a lower cost base (in fact, Biocon already has FDA approval to make insulin) if Hospira is too expensive.

I agree that greater government would be beneficial, as it is now, there is not sufficient monitoring by the FDA, and in 1997, the FDA stopped mandating that manufacturers’ conduct batch testing, giving the green light to even less regulation for the brand-name drug companies (since there are no generics being sold).

But because the margins on insulin are so attractive, there is NO shortage of interest from new would-be competition today. Right now there are 3 new insulins pending FDA approval, and a few more that are still in earlier-stage development (Phase II trials). Catch my recent post on that subject here.

I am really lost on what you exactly you are saying. I fully expect Humalog and Novolog will come of out protection and there will be a price drop as variants of those insulins come on the mark, much as Relion has done for R and NPH. But it is going to cost $20-25 like the Relion, not $4 like metformin. And do you not think that the removal of older insulins that we have already experienced over the years is not a foreshadowing of how weak the insulin market actually is. There are still some old-timers who crop up and lament the unavailability of pork and beef insulins.

I don’t doubt anything that you post about the innovations in the market, what I doubt is that insulin is going to come down in end cost to the patient. And of biggest concern is those who lack insurance and the ability to access medical care, they will still have to pay $24/vial and they will still require a prescription to get any “generic” form of humalog or novolog.

ps. I just made up the $100M number, but realize at $4/vial (instead of $100/vial), the current $500M humalog market is only worth $20M.

Test strips are not a prescription item. You can buy over-the-counter, but you have to pay the full price. It’s just a lot cheaper if you have a prescription and run it through your insurance.

I actually have bought test strips off of ebay (when I was between insurance plans) and had no issues. I probably made 4-5 purchases of test strips online and they all worked just fine. Obviously, it’s a risk, but one I had to take in order to get what I needed.

Have you looked at buying from Canada? I’ve heard people have had good experiences with www.northwestpharmacy.com.

Yes, I’ve bought test strips off of ebay, no issue. You can also get insulin from walmart and it’s A LOT cheaper (about $25/vial of R and NPH). They carry the pens too, but I’m not sure what the cost is on those. Walgreens also carries pens and they are cheaper than every other place I’ve found.

Try to find clinical trials. You can sometimes try out new insulins and trial pump sets. They will usually pay for all your supplies. The trial I am on pays for all my testing supplies including strips, lancets and meters for the duration (2 years).

It’s not very profitable. Also, insulin is a protein based chemical produced in the body and tagged via specific parts of the cells with a tiny chain of glucose to identify it to the body. The production costs of insulin far exceed that of ordinary drugs - it’s not just a chemical chain put together in a lab. Bacteria have to be raised to produce insulin with a specific protein/DNA chain that is tagged properly, otherwise the body will simply reject it. rDNA insulin is a modern genetic miracle.

You might want to check out the http://www.pparx.org website. You’ll have a bunch of forms to fill out and have your endo fill out as well, but it’s worth the work. I work in my endo’s office to get my CDE hours and I’ve helped many patients fill out this paperwork and as long as you don’t have insurance you’ll be golden!

Liz

PS- it includes name brand drugs and test strips

I had to buy a Walmart relion meter and strips, and pay 49 dollars for 100 strips,. I also can buy and have 100 syringes 31 guage for 14.99 from walmart. And they Have relion NPH Insulin for 22 dollars. so it is cheaper, not sure if you want this kind of chep, its up to you:)

10 ml bottles and syringes would be the lowest cost. Instead of Novolog/Humalog at $100 a bottle you can go to Sam’s Club and buy a bottle of Novolin R for $24…of course instead of taking an injection 15 minutes before eating you would have to take it 1-1.5 hours before eating. I know about the Novolin R because my cat knocked a full bottle of Novolog off the table and onto the tile floor…crash! I wasn’t about to spend $100 but having to wait over an hour to eat can play havoc on your mind if you drive a service truck for a living.

But the relion R and N are not cheap because they’re out of patent or being made by another company, they’re cheap because walmart buys large amounts of them at a time - they’re still manufactured/packaged by Novo, the cost savings comes in because Novo doesn’t have to deal with distribution or marketing - that’s all Walmart, who passes the “savings” on to it’s customers.