Glossary of Terms
Calendar Year (CY)
The time frame between January 1 and December 31.
Company Level R&D
Aggregate research and development (R&D) costs submitted for the most recent year for which final audit data is available. The quality of the data must be consistent with the quality and types of information and data that the manufacturer includes in the manufacturer's annual consolidated report on Securities and Exchange Commission Form 10-K or any other public disclosure.
The effects of a drug which have been reviewed by United States Food and Drug Administration’s Center for Drug Evaluation and Research and determined that the drug provides benefits that outweigh its known and potential risks for the intended population.
Chemical name or non-proprietary name of a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version.
Loss of Patent Exclusivity
Refers to the date on which a patent term ends.
The lowest WAC price from either:
· the last CY if the cost increased by 15 percent during that last CY; or
· the lowest WAC price from the last three CYs if the price increased by 40 percent during that last 3 CYs.
This WAC is NOT necessarily the same price as the price reported for the annual WAC report.
Name of pharmaceutical drug manufacturer. A person engaged in the business of producing, preparing, propagating, compounding, converting, processing, packaging, labeling, or distributing a prescription drug. The term does not include a wholesale distributor or retailer of prescription drugs or a pharmacist licensed under Subtitle J, Title 3, Occupation Code.
The term also includes firms that hold the New Drug Application, Abbreviated New Drug Application, or Biologic License Application for a prescription drug.
The term does not include outsourcing facilities or manufacturers of United States Pharmacopeia-grade medical gases for which there is no NDA.
National Drug Code description. Information about labeler, drug type, quantity, strength and dose.
The unique 11-digit National Drug Code that is a universal product identifier for human drugs in the United States.
Also known as brand name or proprietary name. A drug sold by a drug company under a specific name or trademark and that is protected by a patent.
Branded products are not generics. A brand can be first-in-class. It is protected by a patent or statutory exclusivity or has an expired patent or exclusivity. These are licensed under a New Drug Application by the U.S. Food and Drug Administration. Brand products are also generally referred to as innovator drugs.