There&#x27;s more to the buproprion HCl fiasco.  The active ingredient produced by the generics manufacturers was the same.  The delivery mechanism was different.  The approval for the 300 mg XL version of the pills was <i>extrapolated</i> from 150 mg XL pill data, rather than compared with the Wellbutrin XL 300 mg.  There wasn&#x27;t even a check for chemical equivalence there.<p>You could have dropped the pills into an artificial stomach and measured concentrations at 20 minute intervals.  That tests chemical equivalence.  You don&#x27;t need to test bioequivalence until <i>after</i> that.  If your synthetic stomach setup does not show <i>chemical</i> equivalence, that&#x27;s when you need to get the animal test subjects.<p>Part of the problem here is that the FDA bundles several different tests into one.<p><pre><code>  - Does the molecule do harm to a human body?  What are the side effects?
  - Is the drug effective for a specific medical condition?
  - How does a higher or lower dosage affect the observed results?
  - How effective is a given delivery mechanism?
</code></pre>
Those questions should really be answered separately, and in that order, for initial approval.  Generics would then only need to re-answer question 4 if the delivery mechanism was different.<p>Take a look at this article about how manufacturers extend exclusivity by tweaking the delivery mechanism: <a href="http:&#x2F;&#x2F;www.pharmaceuticalcommerce.com&#x2F;index.php?pg=manufacturing_and_packaging&amp;articleid=27193&amp;keyword=drugs-pharmacology-technologies-FDA" rel="nofollow">http:&#x2F;&#x2F;www.pharmaceuticalcommerce.com&#x2F;index.php?pg=manufactu...</a>