Lovenox generic

[Marty]

FDA approves generic version of Lovenox.
The AP (7/23) reported that "Momenta Pharmaceuticals Inc. said Friday the US Food and Drug Administration approved its generic version of Sanofi-Aventis SA's Lovenox [enoxaparin], an injected drug for preventing life-threatening blood clots."

The Los Angeles Times (7/24, Zajac) reported that "in its decision, the FDA also rejected an argument by Lovenox's maker, Sanofi-Aventis, that its drug, which is made from sugar molecules found in heparin, a substance derived from pig intestines, is too complex to be copied with precision by makers of generic versions of the medication."

The New York Times (7/23, Pollack) "Prescriptions" blog reported that "Momenta, which applied for approval of its drug five years ago, claims its technology can accurately characterize such complex mixtures." The Wall Street Journal (7/24, Mundy), the Boston Globe (7/24), and MedPage Today (7/23, Neale) also covered the story

 

[Ross]

FDA approves generic version of Lovenox.
The AP (7/23) reported that "Momenta Pharmaceuticals Inc. said Friday the US Food and Drug Administration approved its generic version of Sanofi-Aventis SA's Lovenox [enoxaparin], an injected drug for preventing life-threatening blood clots."

The Los Angeles Times (7/24, Zajac) reported that "in its decision, the FDA also rejected an argument by Lovenox's maker, Sanofi-Aventis, that its drug, which is made from sugar molecules found in heparin, a substance derived from pig intestines, is too complex to be copied with precision by makers of generic versions of the medication."

The New York Times (7/23, Pollack) "Prescriptions" blog reported that "Momenta, which applied for approval of its drug five years ago, claims its technology can accurately characterize such complex mixtures." The Wall Street Journal (7/24, Mundy), the Boston Globe (7/24), and MedPage Today (7/23, Neale) also covered the story

Wonder when it becomes available? Sanofi is flipping out because now they won't get their $900+ a box.

 

[AgilityDog]

Good. Sanofi has a very bad industry rep. I'm glad there will be another option.

 

[Maryka]

Yep. Lovenox is extremely overpriced! I will never forget how my credit card company telephoned me several times, starting at the drugstore, when I had to use their card for paying for Lovenox. (I love the name LOVE + NOX, as in obNOXius. This is how I remember to spell the name of this drug.)

 

[ALCapshaw2]

What is the NAME of this new generic version of Lovenox?

(Marty - I read your post twice and still don't see it)

'AL'

 

[Ross]

M-Enoxaparin
Our most advanced product candidate, M-Enoxaparin is designed to be a generic version of Lovenox (enoxaparin sodium), a low-molecular-weight heparin product (LMWH). Lovenox is a complex mixture composed of thousands of distinct complex sugar chains. Lovenox is the most widely prescribed LMWH used for the prevention and treatment of deep vein thrombosis (DVT) and treatment of acute coronary syndromes (ACS).

Our ability to sequence and analyze complex mixtures has allowed us to analyze Lovenox and develop a process that we believe can be used to make a generic version of Lovenox that will meet the FDA requirements for ANDA approval. We have collaborated with Sandoz to jointly develop, manufacture and commercialize M-Enoxaparin in the U.S. and the European Union.

 

[Marty]

What is the NAME of this new generic version of Lovenox?

(Marty - I read your post twice and still don't see it)

'AL'

M-Enoxaparin

 

[Maryka]

Since I will have to go on Lovenox for my rapidly approaching hip replacement, is this generic drug approved NOW?

 

[Ross]

It's approved, but it's not out on the market that I can find.

Might email them and see when it's going to start showing up in the market:

[email protected]

 

[Maryka]

Well, I will try to post on this site when I get my Lovenox-like RX prior to my hip surgery. My insurance insists on using generics if they are available, so I will get the generic if it is out there. On the other hand, my deductible is all done for 2010, so the brand-name version will not cost me nearly as much as it had previously.

 

[Ross]

It was just FDA approved 6 days ago, so I highly doubt it's going to be available very soon.

 

[Cris N]

It was just FDA approved 6 days ago, so I highly doubt it's going to be available very soon.

I would disagree. I read some SEC filings... they really need to get this out on the market.

 

[Marty]

My wife is on Hysaar a very expensive ARB diuretic combo. My pharmacist and I kept our eye on it. He got it at the low generic price within days after it went generic. My advice, if you've got a good personal pharmacist have him or her ready with a prescription.

 

[Jkm7]

I agree....... If you have a good relationship with a good pharmacist, advise him of your upcoming need for it and request it get it stocked as soon as possible. My pharmacy is good in that sort of personal service.

 

[Maryka]

I was taking Hyzaar (Losartan + a diuretic), by the way, but the pre-generic price was ridiculous. My cardiologist changed the RX to Losartan with a secont RX for hydrochlorothiazide--a cheap diuretic. When the generic Losartan became available, I switched to that. I guess I will stick with the current drugs, but I just want to acknowledge that I understand now they have a generic Hyzaar as well.

I will probably line up my Lovenox (or alternative) soon...Stay tuned, ha ha!

 

[Cris N]

Some updated information is here: http://www.theheart.org/article/1107181.do

Lovenox manufacturer, Sanofi-Aventis, has filed a lawsuit in federal court to reverse the FDA decision. In the meantime, this paragraph from the article:

In a status conference held by the US District Court for the District of Columbia on July 26, 2010, the Hon Emmet G Sullivan denied the company's request for a restraining order to stop sales of the product, which began shipping immediately on approval. A hearing to consider a preliminary injunction has been scheduled for August 17, 2010, Momenta officials said in a news release.

So, assuming that the approval holds, the product should be available quite soon.

 

[AgilityDog]

It's Available NOW

It's Available NOW

I start bridging tomorrow for surgery Wednesday. Yesterday I picked up my generic lovenox at Wal-mart pharmacy: Low low price of $10 generic co-pay. Without insurance it runs for about $250 per the clerk.

My sister works for Sanofi which makes Lovenox. She knew when I saw her 2 weeks ago that this was coming out, but didn't know if it would be out in time for me to use it. Sanofi has a bunch of people in that lovenox division who might just get moved or lose jobs with this generic now available. My sister did not express any concerns about me using the generic over the brand name, despite any company loyalty she may have. So I take that as a good sign this stuff works.

 

[Cris N]

Good news. Thanks for posting this, Laurie.

 

[Ross]

$250 vs $900+, that's a no brainer even for insurance companies.

 

[Maryka]

I just found my prescription among the papers my cardio sent me to take to Duke Hospital for my hip replacement. I am goiong to get it filled up here in MD rather than find a brand new pharmacy in NC. I will report back soon on costs, etc.