I'll be the first to admit I don't know, but something peculiar was happening with Libigel. Libigel safety/efficacy study has over 7000 women years of data and they got a peak under the hood at the clinical data. Then Biosante announces a merger with ANI who own Solvay's former factories with transdermal capabilities in Baudette, MN and stop clinical examination which was due for release in 1 to 2 months, or so they say.
Abbvie then hires Dr. Snabes the study director/inventor.
Then I see that March 14, 2014 Abbvie filed a patent application regarding FLUID APPLICATORS FOR USE WITH TOPICAL MEDICATIONS.
Abstract
Fluid applicators for use with topical medications are disclosed herein. An example apparatus includes a housing and a fluid container disposed inside the housing. The example apparatus also includes a pump assembly disposed inside the housing and fluidly coupled to the fluid container. The example apparatus further includes an applicator coupled to the housing. The applicator defines an outlet and has a surface to be in contact with an application site on a person. The surface is in fluid communication with the pump assembly via the outlet. The example apparatus also includes an actuator operatively coupled to the pump assembly. Movement of the actuator from a first position to a second position is to operate the pump to dispense a dose of the fluid onto the surface.
In the application they use often cite the application of testosterone as one of the examples for it's use.
US Patent application # 20140270897
http://appft.uspto.gov/netacgi/nph-...ND+testosterone&RS=AN/abbvie+AND+testosterone
Note: The provisional patent was filed Mar 15, 2013, around the time Dr. Snabes was hired by Abbvie.
I seriously doubt this patent application was intended for Androgel. Combined with the fact nothing has ever been released about the CV risk reduction benefits other than in the patent application, leads me to believe that Abbvie has something in the works and they are holding tight to their chest until a patent is secured. Incidentally the patent examiner has based initial rejection on prior art owned now owned by Abbvie (through Solvay acquisition) but lacking the clinical data to support it. ANI has the clinical data. However it appears if they go Abbvie's route, Besins would be entitled to 50% of Abbvie's patent rights and it appears they would lose approx. 8 years of patent protection.
If on the other hand ANI gets their patent for CV benefits you are looking at at approx. 16 years of patent protection.