March 7, 2013

How long until a drug goes generic?

Informative readers have pointed out various websites that give clues about when currently high-priced on-patent drugs might be available as generics. For example, here's an FDA site

But it's not exactly user friendly, especially when you consider that a huge fraction of patients are not quite as sharp as they used to be. For example, here's what I get for Lipitor, the biggest revenue drug in the history of pharmaceuticals, which I've been getting generically for around a year:

Patent and Exclusivity Search Results from query on Appl No 020702 Product 001 in the OB_Rx list. 

Patent Data

Appl
No
Prod
No
Patent
No
Patent
Expiration
Drug Substance
Claim
Drug Product
Claim
Patent Use
Code
Delist
Requested
N0207020015686104Nov 11, 2014YU - 213
N0207020015686104*PEDMay 11, 2015U - 213
N0207020015969156Jul 8, 2016Y
N0207020015969156*PEDJan 8, 2017
N0207020016126971Jan 19, 2013Y
N0207020016126971*PEDJul 19, 2013

Exclusivity Data

There is no unexpired exclusivity for this product. 

I'm pretty baffled by the rows of information, but it looks like the sentence at the end is pretty clear: "There is no unexpired exclusivity for this product."

But for products that are still on patent, it's not at all clear what's going on:

Patent Data

Appl
No
Prod
No
Patent
No
Patent
Expiration
Drug Substance
Claim
Drug Product
Claim
Patent Use
Code
Delist
Requested
x003z*PEDJul 16, 2012
x003qFeb 14, 2014YY
x003e*PEDAug 14, 2014
x003rAug 30, 2012U - 629
x003y*PEDMar 2, 2013
x003p*PEDJul 16, 2012

Exclusivity Data

Appl NoProd NoExclusivity CodeExclusivity Expiration
x003M - 61Oct 10, 2015

x003PEDApr 10, 2016

So , how much longer until a patient can get it generically?

This would seem like the kind of thing that Cass Sunnstein, the Obama Administration's Nudgeocrat, could more profitably devote his time to doing than to his previous bright ideas like having the government battle on-line conspiracy theorizing by organizing a conspiracy to infiltrate conspiracy theorizers and plant more pro-government views. (The history of agent provocateurs raises severe questions about this approach.)

Cass, why don't you use your big brain to make it easy for an 80-year-old to figure out how long until his brand name medicine goes generic?

The other issues is that there is a lot of leeway in when things go generic because of anti-competition conspiracies between patent-holders and generic manufacturers. I'd like to see a scorecard where that gets spelled out in comprehensible detail. Make it easy to tote up just how much healthcare spending is boosted annually by anti-competitive agreements between patent holders and generic manufacturers. I wouldn't be surprised if the number is something like $100 billion annually. And yet, you almost never hear of it outside of investors' discussion groups.

4 comments:

Anonymous said...

How long until drug goes legal?

Anonymous said...

The economic consulting firm I worked for once handled a case about keeping generics off the market this way. We argued that while the manufacturer had no generic competitors, they gave away a lot more free samples, making consumers actually better off. This was before I joined, so I don't know the exact results, but I think the court bought it.

Operation Mangosteen said...

Mangan had an old post (now offline, with all of his old archives) called 'Don't Take Statins if you Need a Functioning Brain." Are you sure you need lipitor?

I'd poke through Paul Jaminet's writings on the subject and still see if you think you need it...

http://perfecthealthdiet.com/category/biomarkers/hdlldlcholesterol/

Portlander said...

+1 on the stay clear of statins

Unless you've already had a heart-attack, their efficacy is completely unproven.

Do you have any risk factors besides total cholesterol count? To entertain a statin, you should also be exhibiting hypertension, small-dense LDL specifically _measured_ by a sub-fraction test, and a cardiac calcium deposit measurement. I'd also want to see some sort of lifestyle risk factor being exhibited: pear shape gut, heavy smoker/drinker,

And even with all those, I'd still try a year of dietary supplements of vitamin K2, D3, and EPA Omega-3, plus 0 wheat intake to see if that reversed the problem.

You come from a long line of long-lived men. Don't let some glorified car mechanic (AKA MD) sell you an Alzheimer's diagnosis 10 or 15 years from now.

But if you insist on the statin, be sure to supplement with CoQ10.

Good luck.