Companies

Open Companies -- in the sidebar under Drugs & Markets.

The FDA files products under the exact applicant name on each application, so one company often appears under several spellings and subsidiaries. Companies rolls those filing names into one company and answers, for each maker: what it sells, which of its brands lose protection soon, which generics it has waiting, and where it is short or recalling.

Data sources

• FDA Orange Book -- brands (NDA products), generic products (ANDA products), molecules, patent and exclusivity dates, and the other companies making each molecule.
• FDA Purple Book -- marketed biologics and biosimilars, and the biosimilars licensed against each reference biologic.
• Staged generics -- ANDA filings that passed FDA review but are not marketed yet.
• Patent Cliff calendar -- market-open dates and Medicare Part D spend (2024 data) for the company's brands, read from Patent Cliff.
• FDA drug shortages -- current shortages naming the company.
• FDA recalls -- drug recalls the company started in the last 12 months.

Only marketed products count. Orange Book products flagged discontinued and Purple Book products flagged discontinued are left out of every count.

Overview page

Header

• A search box, Find a company. Press / anywhere on the page to jump to it.
• Four totals across every company listed: companies, active brands, generic products and biologics.

Who makes what

A chart of the companies in the current list: brands across, generic products up, dot size for biologics, on square-root scales. The corners are labelled Generic houses, Brand innovators, Hybrids and Biologic-first. It plots the top 40 of the current list (it follows the search, the profile filter and the sort) and says Top 40 of n when the list is longer. Hover a dot for the company's counts and profile; click it to open the company.

Profiles

Each company gets one profile from its mix, where a brand and a biologic each weigh six times a generic product:

The chips above the list (All, Brand-led, Generic-led, Biologic-led, Hybrid) filter by profile, each with its count.

The list

Sort by Largest (marketed Orange Book products plus biologics), Most brands, Most generics or Most biologics. The count of matching companies sits next to it.

The list shows 40 companies; Show all n lists the rest. Companies with no marketed product or biologic are not listed.

Company page

Header

• A Companies link back to the list.
• The company's initials, its profile and name.
• Watch adds the company to Radar as a maker, which tracks its Orange Book portfolio.
• Share report creates a client report (see Client report).
• The read -- how many brands, generic molecules and biologics the company holds, how many of its brand markets lose protection by the end of next year and the Medicare Part D spend on them, how many current FDA shortages name it, how many recalls it started in the last 12 months, and how many molecules it has staged generics waiting on.
• Filed under n FDA names -- the applicant names rolled into this company, up to six shown. Each opens the Orange Book or Purple Book table filtered to that name. Check this line when a company looks larger or smaller than you expect.
• A ring of product lines: brands, generic molecules and biologics.

Stat band

When its number is not zero, each label opens the matching table or view: the Orange Book filtered to the company's NDA or ANDA products, the Purple Book, Patent Cliff, or the recalls table.

Protection runway

When each brand loses its last patent or exclusivity: a timeline from 2020 to 2042 with one bar per brand, running from today to the brand's latest Orange Book patent or exclusivity date.

• The shaded Cliff window runs from today to the end of next year. Brands that lapse in window are amber, Protected brands run past it, and Already lapsed brands show where protection ended.
• When more than three brands have no patent or exclusivity on file, they are folded into one row.

Tabs

A tab only appears when it has something to show, except Shortages and recalls, which always appears. Long tables show 25 rows; Show all n lists the rest.

Brands

Every brand with an active NDA product. Sort by Soonest exposed, A-Z or Most generic makers.

Generics

Molecules the company holds an active ANDA for. Turn on Thin markets, 3 rivals or fewer to keep the molecules where few other companies compete.

Biologics

Marketed Purple Book products, one card each. Filter by All, Reference or Biosimilars. A Reference biologic card shows how many biosimilars FDA has licensed against it (linked to the Purple Book), or No biosimilar licensed. A Biosimilar card names its reference product. Each card shows the first licensure date.

Cliff

Brand markets where the last patent or exclusivity lapses by the end of next year, read from the Patent Cliff calendar, so the dates are its market-open dates resolved across every Orange Book listing. They can differ from the Brands tab, which uses the latest date on the brand's own listings.

• A summary of the Medicare Part D spend on those brand markets and the first one to open. A brand that appears under more than one market counts once.
• One card per market: whether the patent or exclusivity lapses, a countdown to the market-open date, its Part D spend (the Medicare floor estimate shown on Patent Cliff), Generic makers and Staged generics. A staged count opens the drug's Drug Profile on its Regulatory tab.

Staged generics

Generic filings by this company that passed FDA review and wait for the brand's protection to end before they can launch.

Shortages and recalls

• Current FDA shortages -- drugs on the FDA shortage list naming this company with status current, their dosage forms and the worst availability reported. A drug name opens its Drug Profile on the Supply tab. See Shortages Tracker.
• Recalls started in the last 12 months -- a month-by-month strip (Class I red, Class II amber), then one row per recall with its date, classification, recall number (linked to the recalls table), product, reason and status.

When a source does not load

If the Patent Cliff calendar, staged generics or the FDA shortage list does not answer, the page says which one did not load and leaves it out rather than showing it as empty. The stat band shows -- for the cliff, and the shortages panel says The FDA shortage list did not load. This is a temporary error, not a clean record. Reload in a moment to retry.

Client report

Share report on a company page creates a public, read-only link to that company:

• Anyone with the link can open it for 30 days, without a Qope account. After that the link stops working.
• It shows the header, stat band and protection runway, then every tab one after another with all rows, without the sort and filter controls, Watch or Share. Cliff countdowns show days only.
• The report header says who shared it and when, the date it was generated and the sources it reads: FDA Orange Book, Purple Book, staged generic approvals, drug shortages and recalls, and CMS Medicare Part D data. The footer shows the date the link expires.
• The report is built when it is opened, so it reflects the data Qope holds at that moment, not a frozen copy.
• Print or save as PDF opens your browser's print dialog.
• Report pages are hidden from search engines.

Creating a link needs a Pro or Teams plan. On other plans the button shows Sharing reports requires a Pro or Teams plan.

Exports

These pages have no CSV export. Use the client report to share or print a company. Every count links to the database table behind it, which you can export from there.

Metering

Opening the Companies list or a company page uses one credit. Opening a client report does not. See Usage and Limits.

Related

• Drug Markets -- whole drug classes, with each molecule's holder linked to its company page.
• Patent Cliff -- the calendar behind the Cliff tab.
• Drug Profile -- one molecule in full.
• Shortages Tracker -- the full FDA shortage list.