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!
Compound name
Name of the active ingredient contained in a pharmaceutical product, e.g. Imatinib, Dasatinib, Nilotinib, Bosutinib, Ponatinib, etc.
Generic drug
A medical product that is comparable to a brand/reference listed medical product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent protection and market exclusivity ends
Counterfeit
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.
Brand name
Name under which a drug is marketed by a specific manufacturer, which is different to the compound name which describes the active ingredient contained in a pharmaceutical product
Copy drug
A medicine provided by third party manufacturers despite the medicine is still patented
Bosutinib
Bosutinib (development name SKI-606, trade name Bosulif), a second generation tyrosine kinase inhibitor.
Also called Bosulif|SKI-606|SKI606
Dasatinib
Trade name: Sprycel, development name: BMS-354825, inhibits BCR-ABL and SRC tyrosine kinases. Authorized for marketing in the EU since 2006 for the treatment of CML and Ph+ALL.
Other names: BMS-354825|BMS354825|Sprycel
Nilotinib
Trade name: Tasigna, development name: AMN107, inhibits BCR-ABL tyrosine kinase. Authorized for marketing in the EU since 2007 for the treatment of CML and Ph+ALL.
Other names: |AMN107|Tasigna
Ponatinib
Trade name: Iclusig, development name: AP24534; a third-generation tyrosine kinase inhibitor
Other names: AP24534|Iclusig.
Generics
A class of medicinal products where the drug is comparable to a branded 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.
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
Gene
A unit of information present as DNA; a gene usually contains the blueprint for a protein.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.