API product-patent expiries to 2031 with current DMF/CEP sources
Active ingredients whose latest Orange Book-listed product patent expires within five years, with the number of organisations holding a current DMF or CEP for each. Recount behind the patent-cliff report.
Revision 2026-10-23.3, published 23 Oct 2026, 15:23 UTC · SHA-256 e76ab76fe7ca1464927c35dd638c47908ddcf7238cabe7a841cb98aaca439317
- Population
- Ingredients with a dated Orange Book patent (683 on 23 Oct 2026) whose latest listed product patent expires between 23 Oct 2026 and 23 Oct 2031 (156; 92 within three years).
- Method
- Patent dates are product-level. Organisation counts are calculated by the same code as the API pages and the concentration dataset (lib/evidence-model.js): an active Type II DMF or a CEP whose latest revision is Valid, one count per legal entity.
- Limitations
- A product patent date is not an ingredient patent and not a market-entry date, and a documented source says nothing about commercial readiness. Revisions .1 and .2 were counted before the 23 October link repair; revision .3 recounts with the shared code (brivaracetam 24 to 23, drospirenone 13 to 12; the 92, 19 and 35 headline figures are unchanged). The August 2026 edition counted all suppliers on record, including historical DMFs; on current records, 19 of the 92 three-year expiries have no current source (August: 16 with none on record).
- Licence
- Derived counts under CC BY 4.0 (credit “PharmaTek Intelligence”). Orange Book and DMF data are US public domain; CEP data reproduced from EDQM with permission.
Columns
| Column | Meaning |
|---|---|
| api_name | Active ingredient |
| slug | PharmaTek page: /directory/api/{slug} |
| latest_listed_product_patent_expiry | Latest patent expiry listed in the Orange Book across approved products containing the ingredient |
| organisations_with_current_dmf_or_cep | Organisations with an active Type II DMF or a valid CEP for the ingredient |
| orange_book_products | Orange Book products containing the ingredient |
| organisations | The counted organisations (from revision 2026-10-23.3) |
How this revision was built
The file is generated by code, not by a hand-written query: the build script reads the inputs below and counts organisations with the same module the API pages use, so the release and the live pages apply one rule. Both the code as run and its frozen inputs are published, so the file can be rebuilt byte for byte:
- build-release.mjs, evidence-model.js and entity-guard.js (the code as run)
- Frozen inputs (gzipped JSON of the API, DMF/CEP supplier and certificate rows, fetched 23 Oct 2026, 15:23 UTC)
node build-release.mjs --dataset api-patent-expiry-current-sources --revision 2026-10-23.3 --from-inputs 2026-10-23.3.inputs.json.gz
# expected SHA-256 e76ab76fe7ca1464927c35dd638c47908ddcf7238cabe7a841cb98aaca439317Revisions
Every published revision stays downloadable. Cite the revision you used; a later revision supersedes it but does not replace it.
| Revision | Published | Rows | SHA-256 |
|---|---|---|---|
| 2026-10-23.3current | 23 Oct 2026, 15:23 UTC | 156 | e76ab76fe7ca1464… |
| 2026-10-23.2 | 23 Oct 2026, 02:58 UTC | 156 | 73650e08871817bc… |
| 2026-10-23.1 | 23 Oct 2026, 02:35 UTC | 156 | 3b39326e4787abc3… |
Earlier revisions were published at a dated path that was overwritten when a correction was made; they are restored here from version control, timed by the change that published each one.
Sources
Certification Online Database. European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, (2026), URL: https://extranet.edqm.eu/publications/recherches_CEP.shtml. Accessed 19 October 2026. Reproduced with permission; the EDQM and the Council of Europe accept no liability for any consequence arising from its use.