Comparison of Bupropion Products
There is confusion concerning generic substitution of bupropion products due to the availability of different formulations, generics with their own “brand names” (e.g., Buproban, Budeprion), look-alike labels, and nonstandardized drug suffixes (SR, XL). The FDA’s Orange Book provides information on therapeutic equivalence of drug products. Therapeutic equivalents are drugs that demonstrate both pharmaceutical equivalence (same active ingredient, dosage form, and strength) and bioequivalence (comparable rate and extent of absorption). Products with actual or potential bioequivalence problems that have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence are rated as AB.12 However, the Orange Book can be confusing to use. For example generic bupropion products are listed as “extended-release” instead of “SR” or “XL.” In addition, the bupropion generics with their own “brand names” are listed by their manufacturer rather than by their brand names (e.g., Budeprion or Buproban). Another resource for identifying pharmaceutical equivalents is the Generic Product Identifier (GPI) codes maintained by Medi-Span. Products that have the same 14-character GPI are identical with respect to active ingredient(s), dosage form, route, and strength.2 However, the GPI does not consider bioequivalence information. The following chart provides information on available formulations, dosing frequency, and therapeutic equivalence of bupropion products. Many states allow therapeutic interchange without prescriber approval of therapeutic equivalents as listed in the FDA’s Orange Book. Note that a Medication Guide must be dispensed with each bupropion prescription.
Abbreviations: BID = Twice daily; HCl = HydroCHLORIDE; TID = Three times daily.
Products | Formulations/ | Usual Dosing Frequency/FDA Approved Indications | FDA Therapeutic Equivalents1,3,a | FDA Equivalence Ratingb | ||||||||
Aplenzin4 | Bupropion HydroBROMIDE (HBr) Extended-Release Tablets 174 mg, 348 mg*, 522 mg Equivalent dosages:
| Once daily Major Depressive Disorder, Seasonal Affective Disorder | None | N/A | ||||||||
Budeprion SR5 Generic Product | Bupropion HCl Extended-Release (SR) Tablets 100 mg, 150 mg | BIDc Major Depressive Disorder | Wellbutrin SR Generics by: Actavis, Anchen (Par), Mylan, Sandoz, Sun (distributed by Caraco), Watson | AB1 | ||||||||
Buproban6 Generic Product (Zyban and Buproban are indicated for smoking cessation. Therefore, product labeling and Medication Guides are different from products indicated for depression.) | Bupropion HCl Extended-Release Tablets 150 mg | BIDc Smoking Cessation | Zyban Generics manufactured by: Actavis, Mylan, Watson | AB2 | ||||||||
Forfivo XL7 | Bupropion HCl Extended-Release Tablets 450 mg* | Once dailye Major Depressive Disorder | None | N/A | ||||||||
Wellbutrin8 | Bupropion HCl Tablets 75 mg, 100 mg* | TIDd Major Depressive Disorder | Generics manufactured by: Apotex, Mylan, Sandoz (also distributed by Major), Teva | AB | ||||||||
Wellbutrin SR9 | Bupropion HCl Sustained-Release Tablets 100 mg, 150 mg, 200 mg* | BIDc Major Depressive Disorder | Budeprion SR 150 mg only; manufactured by Impax, marketed by Teva) Generics manufactured by: Actavis, Anchen (Par), Impax (200 mg; distributed by Global), Mylan, Sandoz, Sun (distributed by Caraco), Watson | AB1 | ||||||||
Wellbutrin XL10 | Bupropion HCl Extended-Release Tablets 150 mg, 300 mg* | Once daily Major Depressive Disorder; Seasonal Affective Disorder | Generics manufactured by: Actavis, Anchen (Par), Impax (150 mg only; distributed by Global), Mylan, Watson | AB3 | ||||||||
Zyban11 (GlaxoSmithKline) (Zyban and Buproban are indicated for smoking cessation. Therefore, product labeling and Medication Guides are different from products indicated for depression.) | Bupropion HCl Sustained-Release Tablets 150 mg* | BIDc Smoking Cessation | Buproban (Manufactured by Impax; Marketed by Teva) Generics manufactured by: Actavis, Mylan, Watson | AB2 |
“*” denotes the Reference Listed Drug (RLD) to which the FDA compared other products. Reference Listed Drugs are drugs identified by the FDA as a product upon which an applicant relies in seeking approval of its ANDA (Abbreviated New Drug Application). It is the standard to which all generic versions must demonstrate bioequivalence.12
- In some cases, manufacturer and marketer may differ. In these cases, both the manufacturer and marketer are identified.
- Products with actual or potential bioequivalence problems that have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence are rated as AB.12 In some cases, the FDA recognizes more than one reference drug. For the purpose of rating bioequivalence, the FDA has compared certain products to certain other products; therefore a number is added to the end of the AB code (e.g., AB1, AB2, AB3, etc). Products rated AB1 are bioequivalent to each other, products rated AB2 are bioequivalent to each other, and so forth.
- For Budeprion SR, Buproban, Wellbutrin SR, and Zyban, initiate at once daily, then titrate up to twice daily dosing as tolerated as early as on day 4 of therapy.5,6,9,11
- For Wellbutrin, initiate at twice daily then increase to three times daily dosing no sooner than 3 days after beginning therapy.8
- Forfivo XL is not for initial treatment. For use in patients who have been receiving a total daily dose of 300 mg of another bupropion product for at least two weeks and who need a dose of 450 mg once daily. Initiate therapy and titrate with another bupropion product.7
Project Leader in preparation of this PL Detail-Document: Melanie Cupp, Pharm.D., BCPS
References
- Electronic Orange Book. http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. (Accessed November 6, 2012).
- U.S. Department of Health and Human Services. Data and variables used for hospice in nursing facility analyses. March 2000. http://aspe.hhs.gov/daltcp/Reports/rpt4-5ap.htm. (Accessed November 6, 2012).
- Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. (Accessed November 6, 2012).
- Product information for Aplenzin. Sanofi-Aventis U.S. LLC. Bridgewater, NJ 08807. August 2012.
- Product information for Budeprion SR. Teva Pharmaceuticals. Sellersville, PA 18960. June 2010.
- Product information for Buproban. Teva Pharmaceuticals. Sellersville, PA 18960. October 2010.
- Product information for Forfivo XL. Edgemont Pharmaceuticals, LLC. Austin, TX 78731. July 2012.
- Product information for Wellbutrin. GlaxoSmithKline. Research Triangle Park, NC 27709. August 2011.
- Product information for Wellbutrin SR. GlaxoSmithKline. Research Triangle Park, NC 27709. August 2011.
- Product information for Wellbutrin XL. Valeant Pharmaceuticals North America LLC. Bridgewater, NJ 08807. June 2011.
- Production information for Zyban. GlaxoSmithKline. Research Triangle Park, NC 27709. January 2012.
- Food and Drug Administration. Center for Drug Evaluation and Research. Approved drug products with therapeutic equivalence evaluations. Orange book preface. 32nd edition. February 3, 2012. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm#Therapeutic Equivalence-Related Terms. (Accessed November 6, 2012).
Cite this document as follows: PL Detail-Document, Comparison of Bupropion Products. Pharmacist’s Letter/Prescriber’s Letter. December 2012.