FREQUENTLY ASKED QUESTIONS

Market Share Dashboard

1) Why do no search results appear when I type my drug into the search bar (Generic Name and Dosage Form)? Why are certain drugs missing from the market share dashboard?

The most common reason that a drug does not appear in the 46brooklyn Medicaid Drug Market Share Dashboard is that it is not a single source product. Single source drug means a drug that is produced or distributed under an original New Drug Application (NDA) approved by FDA and has an approved NDA number issued by FDA, including a drug product marketed by any cross-licensed producers or distributors operating under the NDA. The second most common reason that a drug does not appear in the dashboard is that the medication does not have utilization within Medicaid, so it cannot be assessed for market share.

2) What is an Application Sponsor? 
In the US, companies interested in selling drugs must submit an application of their product to the FDA. These companies are referred to as sponsors within the FDA drug database. Sponsors are required to prepare detailed documents regarding the drug’s safety and efficacy (or bioequivalence for generic applications) that the FDA reviews in order to make a determination upon whether a medication may be sold within the US.

3) How is the number of applications for a generic name and dosage form determined?  

For each unique generic name and dosage form, our database finds the FDA application associated with National Drug Codes (NDCs) that match the generic name and dosage form description. We then count up the distinct number of applications for those NDCs and report that number as the number of applications.

4) What is the relationship between an Application Sponsor and Labeler?

A labeler is any firm that manufacturers (including repackers or relabelers) or distributes (under its own name) a drug. As a result, several labelers may utilize the same sponsor’s FDA-approved application when marketing a drug in the US.

 5) What is the difference between a generic and an authorized generic?

An Authorized Generic is the brand company's own product, already approved as a New Drug Application (NDA) by the FDA, repackaged and marketed as a generic drug either through a subsidiary of the brand company or a third party. We did our best to identify authorized generics based upon the license type and data available from our clinical drug reference files.

A generic drug is a copy of the original brand-name drug that has the same active ingredients, route of administration, dose, and dosage form as the original brand name product that is brought to market under an Abbreviated New Drug Application (ANDA). The FDA approves ANDAs on the basis of the generic sponsor demonstrating their product is therapeutically equivalent to the original brand name drug.