Track the share of Type II DMFs in active vs inactive status for any molecule. A leading indicator of supplier-pool churn and recall impact.
Across 28,872 FDA Type II DMFs ever filed, 15,289 are currently active and 13,583 sit inactive. The 53% active rate is the universe-level baseline; per-molecule cohorts run wider, especially on molecules with NDMA-driven wind-downs (valsartan, ranitidine) or LOE-cliff filings.
Type the INN. The AI agent pulls every Type II DMF ever filed for the molecule from the FDA register, regardless of status.
Active count, inactive count, and active share. Inactive cohort is broken down by deactivation cohort where the FDA publishes a reason (recall, withdrawal, lapse).
Citation-anchored brief with the headline ratio, trajectory, and a chip showing recall-driven deactivations.
When a regulatory recall (NDMA, nitrosamine) hits a molecule, the DMF inactive share rises sharply. The ratio surfaces structural pool stress before a buyer asks 'why are we struggling to source?'
Suppliers deactivate DMFs when they exit the molecule. A high inactive share means active competitors have left and the remaining pool may be smaller than the headline DMF count suggests.
Inactive cohort breaks down by year, by country, and (where published) by reason. NDMA-cohort deactivations look different from voluntary lapses.
FDA Type II DMF register publishes monthly. Status transitions propagate on the next refresh; the catalog row carries the last-computed timestamp.
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pharmagraph_query Twenty molecules · inactive share of total ever-filed Type II DMFs · live register, 2026 snapshot.
The active/inactive DMF ratio is a leading indicator of pool health. PharmaDB tracks the lifecycle of every Type II DMF filing and surfaces the share that has moved out of the active cohort, with recall-cohort tagging where the regulator publishes a reason. The view rests on api_docs and compliance_events. Refresh cadence is monthly.
The 2018-2020 NDMA (N-nitrosodimethylamine) recall wave hit valsartan, telmisartan, olmesartan, and other sartans hard. Multiple Type II DMF holders deactivated rather than re-validate synthesis routes free of nitrosamine impurities. The structural memory shows up as elevated inactive shares across the sartan class today.
An inactive Type II DMF is one the holder has formally deactivated, or one that has lapsed because annual fees were not paid, or one the FDA has closed for other reasons. The dossier is no longer in commercial use; the manufacturer cannot be referenced by an ANDA filer.
Mostly. A young molecule (tirzepatide, edoxaban) has zero inactive DMFs because the supplier pool is still in growth. A mature molecule with low inactive share means the pool is stable. A mature molecule with high inactive share means the pool has churned, which is a structural risk signal.
Deactivations clustered in 2018-2020 across multiple sartans are tagged as NDMA-cohort. The compliance event feed carries the recall publications; the DMF lifecycle view joins on date and molecule to surface the cohort tag.
The headline view is FDA Type II DMFs. The companion view applies the same lifecycle metric to active vs withdrawn EDQM CEPs, with the same recall-cohort tagging where the regulator publishes a reason.
Monthly. The FDA Type II DMF register publishes monthly. The lifecycle metric recomputes on every refresh; the catalog row carries the last-computed timestamp on every result page.
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