The chart below (21) shows the results of bioequivalence tests of the two drugs by measuring concentration of medicine over time for the 150 mg doses of Budeprion and Wellbutrin XL.
It found that the maximum concentration of Budeprion XL 300 in the blood plasma reached only 75 percent of the amount Wellbutrin XL 300 released, and, in some volunteers, the level never reach 40%.
(57) Questions and Answers Regarding Market Withdrawal of Budeprion
XL 300 mg Manufactured by Impax and Marketed by Teva; U.S.
This was recently shown in the comparison between branded bupropion XL 300 mg and generic Budeprion
XL 300 mg.
The planned withdrawal of Budeprion
XL 300 mg is the result of studies conducted by the company and FDA aimed at addressing reports of reduced efficacy from patients who were switched to generic forms of Wellbutrin XL 300 mg made more than 5 years ago.
In a 29-page decision (Budeprion
XL Marketing & Sales Litigation), U.S.
As a result, products that were once designated as generics (Budeprion
XL and Proair HFA, both made by Teva Pharmaceutical Industries Ltd., are two examples) now fall under the rubric of multisource brands.
Recently launched products include lamotrigine tablets, AB-rated to GlaxoSmithKline PLC's Lamictal; divalproex sodium delayed-release tablets, AB rated to Sanofi-Aventis' Depakote; risperidone tablets USP, AB rated to Janssen Pharmaceutica Inc.'s Risperdal; Budeprion
XL 150 mg, AB rated to GlaxoSmithKline's Wellbutrin XL; alendronate sodium tablets, AB rated to Merck's Fosamax; zaleplon capsules, AB rated to King Pharmaceuticals Inc.'s Sonata; cetirizine HCl syrup, AA rated to Pfizer Inc.'s Zyrtec; Selfemra (fluoxetine) capsules, AB rated to Eli Lilly and Co.'s Sarafem; and ropinirole HCl tablets, AB rated to GlaxoSmithKline's Requip.
Endocet $319,179,358.14 Sandoz Atenolol $314,641,161.99 Qualitest Hydrocodone-Acetaminophen $314,499,437.49 Teva USA Budeprion
XL $311,576,927.44 Greenstone Ltd.
Products launched in 2006 include Simvastatin tablets, AB-rated and bioequivalent to Merck's Zocor; Pravastatin Sodium tablets, AB-rated and bioequivalent to Bristol-Myers Squibb's Pravachol; Sertraline Hydrochloride tablets, AB-rated and bioequivalent to Pfizer's Zoloft tablets; Ondanstron injection, AB-rated and bioequivalent to GSK's Zofran; Budeprion
XL (Bupropion HC1 ER tablets), AB-rated and bioequivalent to Boehringer Ingelheim's Mobic.