Drybench Patent: methods and checks

How Drybench Patent reaches its results: every calculator, analysis or view with its methods, the references behind them, how far each has been checked, and the app's limits.

Open Drybench Patent · What the levels mean · Every app's methods and checks

Protection

The dates the FDA's rows give for this product, each named by its rule and traced to its row. A range, never one date.

No method record is kept for this view, so it carries no level.

How it is made and tested

• The summary: A set, never a point: the latest substance patent (with its *PED row where listed), the latest listed patent of any kind, the latest non-patent exclusivity, and the earliest and latest of every rule's dates.
• R1, listed patent expiry: The Orange Book patent row's expiry as the application holder submitted it, including any extension, with its drug-substance, drug-product and use flags, its use code, its delist flag and its submission date. Nothing is verified against the patent itself.
• R2, pediatric exclusivity on a patent: The second row the FDA lists for the same patent, marked *PED, with the amended date, shown as listed and labelled as pediatric exclusivity. The app never adds six months: a product with a PED exclusivity row but no *PED patent row shows no extension.
• R3, non-patent exclusivity: Each exclusivity row's code and date, with the FDA's definition of the code; a code outside the definitions list is shown as such, never guessed.
• R4, NCE-1: The NCE exclusivity date minus one calendar year, shown as the earliest ANDA submission with a Paragraph IV certification; the one computed date, marked as computed.
• Implemented rule traces, including the negative control (a PED exclusivity without a *PED patent row shows no extension), the summary set, NCE-1 and the date window.
• The engine's trace over the synthetic store against the Python second implementation's expected values, field by field.

Patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

No method record is kept for this view, so it carries no level.

How it is made and tested

• R1, listed patent expiry: The Orange Book patent row's expiry as the application holder submitted it, including any extension, with its drug-substance, drug-product and use flags, its use code, its delist flag and its submission date. Nothing is verified against the patent itself.
• R2, pediatric exclusivity on a patent: The second row the FDA lists for the same patent, marked *PED, with the amended date, shown as listed and labelled as pediatric exclusivity. The app never adds six months: a product with a PED exclusivity row but no *PED patent row shows no extension.
• R7, delisted and use-code patents: Kept in the table with their flags: a delist request keeps the patent listed while a first applicant may keep 180-day eligibility, and a use-code patent is shown as blocking the coded use.
• The five parsers against the synthetic fixture: headers found and missing, dates in the FDA's forms and in words, the *PED marker, flags, quoted CSV and a changes section before the Purple Book's header.
• Implemented rule traces, including the negative control (a PED exclusivity without a *PED patent row shows no extension), the summary set, NCE-1 and the date window.

Exclusivity

Each non-patent exclusivity the FDA lists, with its code, the FDA's definition of the code and its date. NCE-1 is the one computed date.

No method record is kept for this view, so it carries no level.

How it is made and tested

• R3, non-patent exclusivity: Each exclusivity row's code and date, with the FDA's definition of the code; a code outside the definitions list is shown as such, never guessed.
• R4, NCE-1: The NCE exclusivity date minus one calendar year, shown as the earliest ANDA submission with a Paragraph IV certification; the one computed date, marked as computed.
• The five parsers against the synthetic fixture: headers found and missing, dates in the FDA's forms and in words, the *PED marker, flags, quoted CSV and a changes section before the Purple Book's header.
• Implemented rule traces, including the negative control (a PED exclusivity without a *PED patent row shows no extension), the summary set, NCE-1 and the date window.

Generics and Paragraph IV

ANDA products grouped by ingredient and dosage form, with their listed therapeutic-equivalence codes. These are candidate relationships, not independently checked RLD matches. Tentative approvals are not included in this store.

No method record is kept for this view, so it carries no level.

How it is made and tested

• R5, Paragraph IV and 180-day: The Paragraph IV list's row as the FDA publishes it: first submission date, number of ANDAs, 180-day status, decision date, first approval, first marketing and the last qualifying patent's expiry. An absent row is never read as no certification.
• R6, tentative approvals unavailable: Tentative-approval data is not included. Separately, candidate ANDA products are grouped by ingredient and dosage form with listed therapeutic-equivalence codes and approval dates; this does not confirm a reference-product relationship.
• The five parsers against the synthetic fixture: headers found and missing, dates in the FDA's forms and in words, the *PED marker, flags, quoted CSV and a changes section before the Purple Book's header.
• Implemented rule traces, including the negative control (a PED exclusivity without a *PED patent row shows no extension), the summary set, NCE-1 and the date window.

Changes

Rows added, removed or changed in the FDA's files between captures, newest first, across every product.

No method record is kept for this view, so it carries no level.

How it is made and tested

• The store: The capture's normalised text per file (header first, rows sorted) with the capture's record of each download, served as content-hashed metadata, a names/dates index and application shards. Initial capture and transformation-only corrections remain archived but are excluded from FDA listing changes.
• The capture script's built-in test: normalised layout, keyed diffs, the heartbeat, a failed source's exit code and the watchdog's allowances.

Date window

Every rule's date that falls between the two dates, with the product, the rule and the applicant as listed. A date here is a listed date, not an entry date.

No method record is kept for this view, so it carries no level.

How it is made and tested

• Implemented rule traces, including the negative control (a PED exclusivity without a *PED patent row shows no extension), the summary set, NCE-1 and the date window.
• The engine's trace over the synthetic store against the Python second implementation's expected values, field by field.

What else is checked

• Join: By application type and number only, with rows shown per product number because patents and exclusivities are listed per strength; the Purple Book joins by BLA number; the Paragraph IV list by one isolated 4–6 digit NDA token, padded to six digits and matched to NDA product rows only. Unresolved rows are retained separately with reasons.

Data sources

• FDA Orange Book data files (products, patents and exclusivities): US government work, public domain (FDA website policies); the classification of this source is held for the General Counsel
• FDA Purple Book data download: US government work, public domain (FDA website policies); the classification of this source is held for the General Counsel
• FDA Paragraph IV patent certifications list: US government work, public domain (FDA website policies); the classification of this source is held for the General Counsel

Limits

Not medical or investment advice. Nothing here is advice about any medicine, treatment or condition, and nothing here is an assessment of any person's variant, sample or molecule. Decisions made with it are yours.

Not regulatory or legal advice. This describes FDA records as they stand. It is not advice on any regulatory strategy, submission, designation or interaction with any agency, and it does not forecast any regulatory outcome.

Not a forecast. Stages, scores, rates, rankings and similarities shown here describe records as they stand, or historical averages; they are not a forecast for any molecule, trial, drug, company or target.

• Not medical or investment advice, and not legal or regulatory advice: listed protection is a range of dates from the FDA's own rows, not a loss-of-exclusivity date, and litigation, settlements, patent term extensions, unlisted patents, at-risk launches, authorised generics and 505(b)(2) products are not in these files.
• Patents and their expiry dates are as the application holder listed them; the FDA does not verify listings, and the Federal Trade Commission challenged more than 100 Orange Book listings in November 2023.
• The only arithmetic is NCE-1, the NCE exclusivity date minus one year; a pediatric six-month extension is shown only where the FDA lists it and is never added here.
• The Paragraph IV list is not complete: the FDA omits some forfeiture decisions and lists only substantially complete submissions, so an absent row never means that no certification was filed.
• Most Purple Book exclusivity dates are blank, because the FDA determines reference-product exclusivity on request, and patents are listed for a handful of biologics only.
• History begins at the first capture, whose date the app shows: the FDA publishes current files only, so nothing before that date can be shown, and a gap in the captures is a gap in the history.
• While the shipped store is the synthetic example, every row on screen is invented in the FDA file layouts for the build, and no date is the FDA's; the app says so on every surface until the first capture replaces it.