Generic Androgel?

Any word on a generic to androgel hitting the market?

 

It won't happen.

 

check out the PAR pharmaceuticals website and news releases. PAR begs to differ...

 

Spring Valley, New York, November 1, 2004 — Par Pharmaceutical Companies, Inc. (NYSERX) today announced that its partner, Paddock Laboratories, has been granted tentative approval by the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for testosterone gel 1%. Unimed Pharmaceuticals, Inc. currently markets testosterone gel 1% under the brand name AndroGel®. AndroGel® is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. The product has annual U.S. sales of approximately $300 million.


A tentative approval reflects the FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of any patents or exclusivity periods accorded to the reference listed drug. A tentative approval does not allow the applicant to market the generic product and postpones the final approval until all patent/exclusivity issues have expired

 

Sounds like they'll sell generic AndroGel... once the patent expires in 2018.

 

Not necessarily. hatch waxman act allows for more challenges to patents. The owner of the patent, once a generic is filed, gets 30 month "stay" as the courts rule on the patent. If not decided in that time frame, a generic can be launched at risk. Thus the generic could be our as early as May 2006. If PAR is confident they can win the patent challenge they will launch in May.

 

I understand that Hatch Waxman, under paragraph IV, allows a generic manufactor to challenge a patent that it considers invalid or that would not exclude the generic agent.

But what is it about our patent with Androgel that PAR considers "invalid?"

Also, once Solvay sues for patent protection, doesn't that kick in an automatic 30 month stay? PAR filled July 03. So if we lose the court case, they can start selling Jan 06? Is that right?

 

Correct....then Solvay is down the shitter!

 

any word on this, kinda scared now

 

Where have you been? That is why Par is promoting Androgel, so they won't come out with the generic.

 

smart for solvay, par, and watson to do this deal. it works in everyone's favor. solvay still profits from the brand until 2015. watson and par also get a little action from the brand. and by the time the patent is up in 2015, the trt market will probably have grown to 4 times the size.
watson and par stand to make more money on generic androgel in 2015 than they would make with generic androgel in 2008 because once companies stop promoting trt, the market will stop growing. all about the benjamins baby. solid deal for everyone.

 

READ THE DATES YOU DUMMIES

 

I do think the PD indication will be a nice touch.

 

According to this Par and Watson were paid off by Solvay not to come out with generic Androgel.I wonder what the implications are and if someone can bring a generic Androgel product to the market now.

http://www.ipwatchdog.com/2009/02/02/ftc-sues-regarding-androgel-patent-settlement/id=1890/

 

The truth is that any compounding pharmacy where the director has an ounce of knowlege on the subject can create a compounded testosterone gel. It's been going on for years under the big pharma radar. A compounding pharmacy can create a product usually at 1/3 to 1/2 the cost of Androgel that meets all FDA standards of efficacy.

I've worked out a deal with a local compounding pharmacy to pay a flat commission ($30-40) for any Testosterone product that he makes for my Androgel customers whose patients can not afford retail prices for Androgel or when insurance coverage is not favorable. My Androgel Rxing MDs know that when Androgel is not available for a patient, go to plan B. All he does is fax the prescription to the pharmacy and I get paid at the end of the month. The bottom line is whenever I lose an Androgel Rx, I still get paid for it and the local compounding pharmacy is glad to have more business coming through their doors, the doctor and the patient are all happy.

You'd be surprised at the number of Testosterone Rx's that I get that Solvay knows nothing about. We're currently expanding to include other compounded products in for our doctors.

 

Wow are you incredibly stupid for a person that seems to have a little bit on ther ball. I hope you make enough on your side business to cover the loss of income you will experience when you are terminated.

 

Actually between the compounding and a few other medical products, I have almost met my Solvay salary including commissions. So actually, it's pretty smart and I am prepared should Solvay move forward with another layoff. In all candor, to live as though Solvay and Androgel is always going to be around, that mentality is "incredibly stupid". The funny thing is we now have 2 other people in other districts doing the same thing.

 

actually Solvay can run your credit and learn about the additional income....explain your way out of that dumbass. You also steal prescriptions from other reps

 

It's not stealing if you never had the Rx. . . Dumbass. Besides, who cares about the other reps. Solvay has already taught us "every man for himself".

And . . . Already thought of the credit issue, it's called a corporation. Owning one is not illegal in America and if you have done it right, Solvay will never know.

 

and I sit here thinking, I hope this fuckstick gets caught. And you will