4 ms·

Mr Mucus? You mean Mucinex/guaifenesin? I'm confused about this example since guifenesin has been approved by the FDA since the 1950s. But it was the time-re

Mr Mucus? You mean Mucinex/guaifenesin? I'm confused about this example since guifenesin has been approved by the FDA since the 1950s. But it was the time-release formulation of the molecule that was given data exclusivity to Reckitt in 2002 (after purchasing it from Adams). There was no "unknown efficacy" tag attached to this medicine. I asked a similar question about Ambroxol a while back (Europeans know this as Mucosolvan). For some reason nobody will take up this one in the USA? I find ambxorol works way better than guifenesin on my kids.

refurb 11y ago
No, you're correct, it was the time released version of guifenesin. The problem was, all the current time-release products were not FDA approved. You can't just create a time-released version and keep your fingers crossed, you need a clinical trial to actually show how it is time released. You wouldn't want a time-released version to release 24 hours of drug in 5 minutes!
- joezydeco 11y ago
  So, by induction, I can take any currently approved molecule and apply a new formulation to it (time-release, liquid vs tablet vs aerosol, etc) and get exclusivity this way? I thought the point was to take old drugs with no clinical data and get them back into the mainstream - this exclusivity was the carrot on the stick. But this seems more like a twist on that idea.
  - refurb 11y ago
    To your first question, the answer is yes. You could take any approved molecule and apply a new formulation and get exclusivity on it. There are many companies that are trying to do just that. Of course, your new formulation actually has to add some value (1 tablet per day instead of 1 table three times per day). To your second point, the Mucinex example is "taking an old drug with no clinical data and getting them back into the mainstream". The difference is that instead of it just being the active ingredient, it's a time released version of the active ingredient. Prior to Mucinex being approved, there were unapproved versions of long-acting guifenesin out on the market. You're right it's not exactly the same as "no one has tested this drug at all", but rather "no one has tested this formulation of this drug".

refurb 11y ago

No, you're correct, it was the time released version of guifenesin. The problem was, all the current time-release products were not FDA approved. You can't just create a time-released version and keep your fingers crossed, you need a clinical trial to actually show how it is time released. You wouldn't want a time-released version to release 24 hours of drug in 5 minutes!

joezydeco 11y ago
So, by induction, I can take any currently approved molecule and apply a new formulation to it (time-release, liquid vs tablet vs aerosol, etc) and get exclusivity this way? I thought the point was to take old drugs with no clinical data and get them back into the mainstream - this exclusivity was the carrot on the stick. But this seems more like a twist on that idea.
- refurb 11y ago
  To your first question, the answer is yes. You could take any approved molecule and apply a new formulation and get exclusivity on it. There are many companies that are trying to do just that. Of course, your new formulation actually has to add some value (1 tablet per day instead of 1 table three times per day). To your second point, the Mucinex example is "taking an old drug with no clinical data and getting them back into the mainstream". The difference is that instead of it just being the active ingredient, it's a time released version of the active ingredient. Prior to Mucinex being approved, there were unapproved versions of long-acting guifenesin out on the market. You're right it's not exactly the same as "no one has tested this drug at all", but rather "no one has tested this formulation of this drug".