Generic Androgel on the Way!!!! Testim Rules

[Anonymous]

BRIEF-Solvay says subsidiary will not to file patent infringement suit against Perrigo Israel Pharmaceuticals
BRUSSELS, July 17 (Reuters) - Solvay SA (Brussels: SOLB.BR - news) :

* Says its unimed pharmaceuticals LLC subsidiary will not to file a patent

infringement suit against Perrigo Israel Pharmaceuticals, ltd

* Says Unimed received a letter from Perrigo (NASDAQ: PRGO - news) advising Unimed that Perrigo had filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market and sell a generic version of AndroGel (testosterone gel) 1% CIII in the U.S. prior to the expiration of Unimed's patent

* Says the receipt of these letters triggered a 45-day period during which time the company could have initiated patent infringement litigation and triggered a 30-month stay of FDA approval of Perrigo's ANDA

* Says in its letter to the company, Perrigo asserted that it did not infringe the AndroGel patent because its proposed testosterone gel product contains a different formulation than the formulation protected by the AndroGel patent

* Says the company does not waive its right to initiate patent infringement litigation at a later stage based on new or additional facts and circumstances

((Brussels newsroom)

 

[Anonymous]

Testim Rules? Generic Androgel will kill Testim as well as branded Agel. Injections too. Testim is 3rd tier in most places. Generic Agel will cost $10. Most Medicare D will block Testim completely. Testim will lose 80% of their 20% share.

 

[Anonymous]

Well put! That just goes to show how low of an IQ the average aux rep has.

 

[Anonymous]

You people are clueless. PAR pharmaceuticals was given exclusive rights to bring a 1% gel to the market and based on litigation cannot bring an Androgel generic to the market until 2016. Go look up the current news dumbass.

 

[Anonymous]

Last post is clueless. The abbreviated NDA for generic AndroGel filed is a different formulation than AndroGel litigated by Par and Watson in 2003. Those formulations where identical to SOlvay's AndroGel in its components. In effect, Par, Waston and Solvay's settlement has no legal hold on this NDA. If reps from Aux and Solvay think that this will not severly impact the branded business than they need to get real. No rep wins here everyone, but the patient looses.

 

[Anonymous]

No sir, you are still clueless. It doesn't matter which company does what with a generic form of the test. gel, it still cannot be brought to market to compete against Androgel or Testim until 2016. It doesn't matter what alcohol based gel formulation you put the 1% testosterone in, generic competition is still prohibited until 2016. It's no different than all the other "formulations" of other drug companies try to bring to market, such as the multiple different formulations of simvastin. All the Lipitor patent litigation fights Pfizer has squashed has been amazing. Many generic companies thought they could do just as you said, "change the formulation a little" and file it as a "new" generic drug. Do some more research my friend, you're still wrong and clueless.

 

[Anonymous]

yaaaaay another option for people who don't want to smell!!

 

[Anonymous]

Are there plans for a scent free version of Testim?...enough people complain about the smell

 

[Anonymous]

There's a reason Auxilium's stock price is over $31.50 as of today! Thank god the ivestors don't listen to you nay sayers. I'll listen to wall street any day before I listen to the bullshit on here.

 

[Anonymous]

I agree with many posters, that Testim smells something fierce, although i must say it was effective for me. I heard the Androgel company is coming out with a 2.5% gel

 

[Anonymous]

Testim Rules? Generic Androgel will kill Testim as well as branded Agel. Injections too. Testim is 3rd tier in most places. Generic Agel will cost $10. Most Medicare D will block Testim completely. Testim will lose 80% of their 20% share.

Exactly right. I can't believe the OP cheered generic Androgel. Thats the kind of myopia that makes stupid reps. Once Androgel is generic, it will have 75% of the 1% gel market. Watch your bonus go down the tubes my friend.

 

[Anonymous]

No sir, you are still clueless. It doesn't matter which company does what with a generic form of the test. gel, it still cannot be brought to market to compete against Androgel or Testim until 2016. It doesn't matter what alcohol based gel formulation you put the 1% testosterone in, generic competition is still prohibited until 2016. It's no different than all the other "formulations" of other drug companies try to bring to market, such as the multiple different formulations of simvastin. All the Lipitor patent litigation fights Pfizer has squashed has been amazing. Many generic companies thought they could do just as you said, "change the formulation a little" and file it as a "new" generic drug. Do some more research my friend, you're still wrong and clueless.

No, YOU'RE wrong my friend. Your Pfizer example is way off, because at least Pfizer fought the generic. Solvay has publicly stated they are nopt going to fight the ANDA. You can expect to see generic Androgel in 6-8 months. Where the hell did you get the 2016 crap???? Androgel is basically Purell hand sanitizer with some testosterone. Not real complicated to duplicate.

2016. Sheesh. What a maroon!

 

[Anonymous]

No, YOU'RE wrong my friend. Your Pfizer example is way off, because at least Pfizer fought the generic. Solvay has publicly stated they are nopt going to fight the ANDA. You can expect to see generic Androgel in 6-8 months. Where the hell did you get the 2016 crap???? Androgel is ybasically Purell hand sanitizer with some testosterone. Not real complicated to duplicate.

2016. Sheesh. What a maroon!

THis poster is correct. Some italian company filed a generic version of androgel and Solvay can't fight it. Generic testosterone gel will be available between 6 to 8 months. At that time both Androgel and Testim will go bye bye..SOlvay will stop promoting Androgel and Auxilium can promote Testim all it wants. The truth is TEstim will not have a chance at tier 3 versus a tier 1 generic version. All managed care companies will push for the generic version. This is common sense.

 

[Anonymous]

THis poster is correct. Some italian company filed a generic version of androgel and Solvay can't fight it. Generic testosterone gel will be available between 6 to 8 months. At that time both Androgel and Testim will go bye bye..SOlvay will stop promoting Androgel and Auxilium can promote Testim all it wants. The truth is TEstim will not have a chance at tier 3 versus a tier 1 generic version. All managed care companies will push for the generic version. This is common sense.

Your tiuming is off. The earliest a geneirc would hit would be 18 to 24 months from the filing. The filing appears to have occured in April. That means almost all next year will be genric free. You are also assuming that the generic application will be approved by FDA. That may be a risky assumption.

 

[Anonymous]

Your tiuming is off. The earliest a geneirc would hit would be 18 to 24 months from the filing. The filing appears to have occured in April. That means almost all next year will be genric free. You are also assuming that the generic application will be approved by FDA. That may be a risky assumption.

NOt that long for a generic! And you are still missing the point. Both Testim and Androgel are screwed when it comes out.

 

[Anonymous]

From one who knows... generic Androgel will be available first quarter of 2010. For whatever that means.

 

[Anonymous]

Absolutely right. Q1 of 2010 is the expected availability date pending FDA approval. An NDA was submitted and barring a 30 month legal block which Solvay could have put in play by challenging the application, the approval could be as soon as six months from application date.
Solvay decided not to challenge in July of 2009.
With the knowledge of the current legal proceedings against Solvay and Androgel by the FTC for their 2005 "pay-to-delay" agreement, I am sure the Obama administration will see that this application gets reviewed on time.

 

[Anonymous]

Managed Care will be salivating over generic Agel. The growth of TRT has been on the payers "radar" for years now. Likely many plans will a block on even 3rd tier Agel and Testim. Note- generic only benefit plans are growing the fastest in the market. I would be surprised if Testim kept their MS at 5% once the generic is out. 90% plus uptake of generics is the norm today.

 

[Anonymous]

Last post is clueless. The abbreviated NDA for generic AndroGel filed is a different formulation than AndroGel litigated by Par and Watson in 2003. Those formulations where identical to SOlvay's AndroGel in its components. In effect, Par, Waston and Solvay's settlement has no legal hold on this NDA. If reps from Aux and Solvay think that this will not severly impact the branded business than they need to get real. No rep wins here everyone, but the patient looses.

Good thing it wasn't a spelling contest or you would "loose"--"severly"

 

[Anonymous]

TRT products make up about 1% of any health plans total annual spend. Not exactly a top priority for MC Pharmacy Directors. But Managed Care will jump on any generic in any category. And a generic option is inevitable so enjoy the ride until then cause no one can stop it. But, a generic Androgel will NOT be available first quarter of 2010 no matter what happens. Could be anytime between 2011-2015...there's still a lot of legal action to come. I doubt Abbott will sit back and let any product ride off quietly into the sunset. Matter of fact, it is likely that part of the reason Solvay didn't file a lawsuit was due to the pending offers. Probably wanted to keep things nice and tidy.