Friday, October 5, 2012

Withdrawal of Teva's Budeprion XL 300 from the US market should benefit IntelGenx Technologies

USFDA has asked Teva to wihdraw - Budeprion XL 300 from the US.  According to USFDA, Budeprion XL 300 is no bioequivalent to Welbutrin XL 300.  It has been found that Budeprion XL 300 releases the active ingredient faster than the original drug Welbutrin XL 300.. The USFDA reviewed the Budeprion XL, after several patients complained
about head aches, anxiety and insomnia.

We think the withdrawal can be positive for IntelGenx which is preparing to launch Forfivo ( bupropion extended release 450mg) and should help the launch trajectory for Forfivo. Forfivo will be marketed by Edgemont pharmaceuticals in the US.  Edgemont focuses exclusively on launching specialty drugs aimed at the neuropsychiatry sector, and has one drug on the market - high-dose fluoxetine (Prozac).

Forfivo is the only single tablet that is formulated to deliver a dose of 450mg.  Until now, those patients who need to take the highest dose (450mg) of bupropion XL need to take multiple tablets of lower-strength doses as there.

Market Opportunity
In 2011, total branded and generic sales of extended-release bupropion totaled $745 million, of which
roughly 20% was for the highest dose (450mg).


  1. Intelgenx has been over looked for a long time... The next Biovail is Intelgenx!

  2. Teva withdrawal is really very opportune. With other catalysts as well in the pipeline, IntelGenx should shine in coming months

  3. Also, the FDA has asked all approved generics to evaluate bioequivalence of their 300 mg product by march 2013 (which were not evaluated as per the old guidance). Again, failure of any generic company to prove bioequivalence will eventually lead to withdrawl from market by may 2013 and can create more space for Intelgenx and Edgemont.

  4. I think Dr. Zerbe's estimate of $6 million was way too conservative!
    But then again, if he over estimated, he would kill the stock!