Promotional materials mention esomeprazole strontium in a "pharmaceutical alternative" to Nexium®. What is the difference between an “equivalent” and an “alternative”?

The FDA considers a pharmaceutical product to be an equivalent or an alternative to another based on certain criteria. The information provided below was taken directly from the FDA.gov website (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm) on 1/21/14.

 

Therapeutic Equivalence-Related Terms:

Pharmaceutical Equivalents.  Drug products are considered pharmaceutical equivalents if they contain the same active ingredient(s), are of the same dosage form, route of administration and are identical in strength or concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules).  Pharmaceutically equivalent drug products are formulated to contain the same amount of active ingredient in the same dosage form and to meet the same or compendial or other applicable standards (i.e., strength, quality, purity, and identity), but they may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling.

Pharmaceutical Alternatives.  Drug products are considered pharmaceutical alternatives if they contain the same therapeutic moiety, but are different salts, esters, or complexes of that moiety, or are different dosage forms or strengths (e.g., tetracycline hydrochloride, 250mg capsules vs. tetracycline phosphate complex, 250mg capsules; quinidine sulfate, 200mg tablets vs. quinidine sulfate, 200mg capsules).  Data are generally not available for FDA to make the determination of tablet to capsule bioequivalence.  Different dosage forms and strengths within a product line by a single manufacturer are thus pharmaceutical alternatives, as are extended-release products when compared with immediate-release or standard-release formulations of the same active ingredient.