Generic Competition Check · method and verification
How was the Generic Competition Check checked, and what did the independent check find?
What was fixed before any figure was published?
The method was frozen on 12 November 2026. The file's SHA-256 hash begins 07cfc57c08db. The tool refuses to build if the method file no longer matches its hash.
What does the independent check do?
- Every product row lands in exactly one group (the builder stops otherwise).
- A separate reader recomputes, for a random sample of 200 groups, the counts of brand and generic products, marketed generics and distinct applicants straight from products.txt; the page's counts must equal them.
- A name search that matches an ingredient returns the same record the page shows.
- A mutation control: removing the generic rows from a group with generics must change its verdict (the control must be able to fail).
- Patent and exclusivity rows that do not join to a product row are counted and published, not dropped silently.
What did it find?
| Measure | Result |
|---|---|
| Groups sampled | 400 |
| Seed | 99 |
| Mismatches | 0 |
A separate reader recomputes brand and generic product counts, marketed generic counts and distinct marketed applicants straight from products.txt. It reuses the same applicant-name normalisation rule as the builder, so that one rule is not independently tested.
The checking has so far led to no amendments to the method.
What is still not covered?
The Orange Book lists patents the application holder submitted; it is not a legal finding. Some brand products are marketed by authorised generics under the brand's own application and appear as brand rows. Biologics are not in the Orange Book (they are in the Purple Book, a separate record). Old products carry the date "Approved Prior to Jan 1, 1982" and have no approval date, so intervals are not computed for them. Ingredient spellings differ across years and a name may appear in more than one group.
How can you check it yourself?
The source data is public: see the FDA Orange Book data files. The dataset, the method and the code that rebuilds it are packaged for deposit on Zenodo. Open the Generic Competition Check to see the result.
Questions about how the check works
What does "frozen before the first publication" mean?
The method was written, hashed and saved before any figure from the data was published. A change after that is an amendment with a date, and the original hash is kept, so anyone can see what was decided and when.
Why does an independent reader matter?
A tool can agree with itself and still be wrong. A separate reader, written without the builder's code, recomputes the figures from the raw files; where the two disagree, one of them has a defect.
Does a clean check mean the tool is always right?
No. It means the numbers match an independent recomputation under the stated method. The limits section lists what the method does not cover.
Further reading: Zenodo, where the datasets are deposited; the FAIR data principles; the National Academies on reproducibility; the author's ORCID record; the FDA Orange Book data files.
Compiled by Vincent Wesley Couey (ORCID 0009-0005-6869-308X).