Competition count
For any drug and dosage form: how many approved makers are still active, how many holders have only discontinued approvals, and how many generics compete. Single-source and no-maker products are flagged.
Live now
Live from the FDA record
The FDA moves every day. See it first.
ReqRX™ joins the FDA's approvals, Orange Book, shortage list, recalls and device clearances, and shows what none of them say alone: how many makers are left, when protection ends, and which cleared devices nobody sells. The best openings go first to the ReqRX™ 100, with 30 years of FDA and patent counsel at the table.
Public FDA data, queried live
No patient data, ever
Drugs, biologics and devices
reqrx / signal searchLIVE
Sources: openFDA and the FDA Orange Book, queried liveFull console + CSV export →
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Drug packages listed in current shortage
openFDA
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Drug recall reports in
openFDA
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Current shortages with 2 or fewer approved makers
ReqRX™ · list for members
2019
FDA history behind every score starts here
Orange Book snapshots, shortages, CMS spending and prices since 2019 · checked nightly
Signal tape
The platform
One record. Every move FDA makes, in one place.
The FDA publishes its decisions across separate databases. Each one is free. What they say together is not: ReqRX™ joins them by product and works out how many makers are left, when protection ends, and which cleared devices nobody sells.
Shortage radar
FDA's drug shortage list, with each product checked against the Orange Book for how many approved makers remain. A shortage with one or two makers is a market opening.
Live nowRecall watch
Drug enforcement reports by product, firm and class, newest first. Part of every maker's track record before you buy from them, or buy them.
Live nowPredicate check
Every 510(k) in a device category, flagged for recalls tied to that clearance and for cleared devices missing from FDA's current listings. FDA's 2023 draft guidance warns against predicates with design-related recalls.
Live nowProtection lookup
Orange Book patents and exclusivities for any brand, with the last listed protection date and the generics already approved against it. Refreshed from FDA nightly.
Live nowPathway and clock tools
The likely FDA route for a drug, biologic or device, its review clock, and statutory exclusivity dates with the year-4 filing window and 30-month stay called out.
Live nowWatchlists and alerts
Follow a molecule, a competitor or a product code. Get one morning brief when anything on your list moves: a new approval, a label change, a shortage or a recall.
In buildShortage history
The FDA shows only today's shortage list. ReqRX™ saves it every night, so members see when each shortage started, how long it lasted and which makers left.
Recording dailyLabel-change diff
When a label is revised, see exactly what changed: new warnings, new indications, dosing. Section by section, side by side.
In buildOpportunity lists
Shortage drugs with few makers, dormant approvals and cleared devices nobody sells, ranked and refreshed nightly.
Members onlyApproval history
Every NDA, ANDA and BLA by brand, ingredient or sponsor, with the first approval, the latest action and the label PDF.
Live nowThe ReqRX™ 100
25 member companies. First look at vetted FDA openings before the open market sees them.
By applicationHow it worksWho it's for
For the people who bring medicine to market, not the people who dispense it.
ReqRX™ is not a pharmacy and never touches a prescription. It is intelligence for the business side of drugs and devices.
Generic and 505(b)(2) developers
Pick targets the record already points to.
- Shortages with 2 or fewer active makers
- Brands nearing loss of exclusivity
- Dormant approvals worth relaunching
503B outsourcing facilities
The FDA shortage list shapes what a 503B facility can make. Watch it daily instead of weekly.
- New and revised shortage postings
- A saved daily record of the list
- Export to your planning sheet
Hospital and health-system supply
See shortages and recalls by product before they reach the floor.
- Recall class and status at a glance
- Shortage status and availability by maker
- How many makers stand behind each product
Medtech founders
Know your pathway and predicate before you spend on testing.
- Recall flags on every candidate predicate
- Every clearance in your product code
- 510(k) vs De Novo vs PMA
Foreign companies entering the U.S.
The FDA map, in plain English, for teams coming from the EU, Asia and Israel.
- Which pathway, which center, which clock
- Who has already cleared similar devices
- IP strategy before first disclosure
Contract manufacturers and operating platforms
See vetted openings first, and check any target's FDA story in minutes, not weeks.
- First look in the ReqRX™ 100
- Approval, recall and shortage track record
- Exclusivity runway
Try it
Two questions every team asks. Answered here.
Which FDA pathway are we on, and how long is the runway? Both tools below run in your browser. Nothing you enter leaves the page.
Pathway navigator
Get the likely route to market, its review clock and its protection.
Exclusivity clock
Enter an approval date and an exclusivity type to see the date it ends.
Exclusivity ends
Statutory exclusivity only. Patents, 30-month stays, forfeiture and litigation can move the real date. Look up a real drug's Orange Book protection and check with your counsel.
Counsel at the table
Software reads the record. Counsel reads between the lines.
Data shows you what happened. Deciding what to do next takes judgment. When a signal turns into a decision about a filing, a patent or a market entry, ReqRX™ connects you to regulatory and IP counsel who have walked drugs and devices through the FDA for three decades.
- Diligence on approvals and dealsGood standing, chain of title, open FDA issues and blocking patents, reviewed before you commit.
- Paragraph IV and first-filer strategyThe 180-day first-generic position, Competitive Generic Therapy designations, and how to hold them.
- Improvement patentsProtection for reformulations, processes and delivery devices, and Orange Book listing strategy.
- Pathways and U.S. market entry505(b)(2) vs ANDA, 510(k) vs De Novo, and the U.S. plan for foreign drug and device companies.
Access
Start with the signal. Join the ReqRX™ 100.
The data is the front door. The ReqRX™ 100 is where the openings it finds go first: 100 companies ready to act, and no more.
The ReqRX™ 100
100 companies. First look at every opening.
Membership is capped at 100 companies that acquire rights and assets for their own operations: generic and 503B manufacturers, contract manufacturers and operating platforms. Every night ReqRX™ finds shortage drugs with few makers, dormant approvals and cleared devices nobody sells. Members see the vetted ones first.
Apply for a seat- Found in the recordSurfaced from the FDA's own data, every night.
- Vetted before you see itChecked for regulatory standing before it reaches members.
- First look, 100 companiesMembers see each opening ahead of the open market. Membership is capped at 100.
- Counsel to act on itRegulatory and IP counsel available under a separate engagement.
Watch
Free
For anyone checking the record.
- Live search: approvals, shortages, recalls, 510(k)
- Competition count, protection lookup and predicate check: 3 searches every 7 days
- Example searches always open
- Pathway navigator and exclusivity clock
Pro
Signal
For regulatory, supply and BD teams.
$1,250 a month · 12-month plan
- 25 competition, protection and predicate searches every 7 days, with repeats free
- A watchlist of 50 drugs, companies and devices, checked every night
- A morning brief by email when anything on it changes: makers leaving, new shortages, recalls, clearances, protection ending
- Loss-of-exclusivity calendar, 36 months ahead
- CSV export of every result
Already a member? Sign in
Pro + reports
Signal Plus
For teams that want the analysis written up.
Price on request · 12-month plan
- Everything in Signal
- A detailed REQ Score™ report on your watched drugs every 6 months
- REQ Score™, crowding risk and supply risk on your watchlist, with each drug's history since 2019
- Additional reports quoted case by case
The REQ Score™ is an informational indicator, not investment, legal or regulatory advice.
Membership
The ReqRX™ 100
For companies ready to act.
By application · 100 companies
- First look at vetted openings
- Ranked opportunity lists, refreshed nightly
- Unlimited searches for your team, 3 seats included
- Up to one written ReqRX™ report a month
- Full shortage history
- Counsel review on request
- Everything in Signal Plus
Founding access
Get the signal before the market does.
Tell us what you watch, or apply for a seat in the ReqRX™ 100. Founding members get Signal first. Applications for the 100 are reviewed one by one.
- No spam, no resaleWe use your details only to contact you about ReqRX™.
- Business data onlyReqRX™ never collects patient or prescription information.