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Glossary on Generics

This page explains some frequently used terms and definitions in the area of generics. Please let us know if you are missing specific terms.

TERM
 DEFINITION
Compound Name Name of the active ingredient contained in a pharmaceutical product, e.g. Imatinib, Dasatinib, Nilotinib, Bosutinib, Ponatinib, etc.
Brand Name, or
Trade Name
Name under which a drug is marketed, e.g. Gleevec, Sprycel, Tasigna, Bosulif, Iclusig, Anzovip, Glimatinib, Veenat, Biotinib, etc.
Original drug, or
Patent-protected drug, or
Innovator product
'Original' drug marketed by companies that developed the drug and thus hold the patents for Gleevec, Sprycel, Tasigna, Bosulif in many countries (e.g. Novartis, BMS, Pfizer, Ariad)
Copy drug Drug provided by third party manufacturers despite the drug is still patented
Generic drug A drug product that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent & exclusivity protection ends.
Counterfeit drug Medicine that is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products. Counterfeit products may include products with the correct ingredients or the wrong ingredients, lacking active ingredients, with incorrect quantities of active ingredients, or fake packaging.
Substandard drug Products whose composition and ingredients do not meet the correct scientific specifications and which are consequently ineffective and often dangerous to the patient. Substandard products may occur as a result of negligence, human error, insufficient human and financial resources or counterfeiting.

 

Please also have a look at our in-depth CML glossary that explains more than 400 terms used in CML-related medicine and regulatory affairs. Let us know if anything important is missing!