For every FDA-approved drug: when does exclusivity expire? When do generics flood in? How have manufacturers serviced it? What does the global picture look like? And is the research field still hot — or has it gone stale?
Each bar shows when the last listed patent expires for that drug. The red line is "now" — anything left of the line has already lost exclusivity. Anything right of the line is still protected.
Click into any drug to see its full profile: patent cliff, NCE exclusivity, DEA schedule, REMS program, NDC manufacturer data, global approval status, and research pipeline.
Not all drugs are available everywhere. Some are approved in the US but not the EU. Some are women-only. Some aren't approved anywhere despite huge trial counts.
| Drug | Country | Agency | Status | Year | Local Brand |
|---|
Is the field hot, active, quiet, or dead? Are the "top of the ladder" indications still being improved — or has research stalled?
New Chemical Entity exclusivity runs 5 years from FDA approval. No generic can be approved during this window. The first ANDA can be filed after 4 years.
When all listed patents expire. Originator files multiple patents: compound, formulation, method-of-use, process. The last expiring patent is the true cliff.
If a generic manufacturer files ANDA with Paragraph IV certification (claims patent is invalid/non-infringing), the 30-month stay begins. First filer gets 180-day exclusivity.
Risk Evaluation and Mitigation Strategy. Required by FDA for drugs with serious safety risks. iPLEDGE (Accutane) is the most stringent — mandatory pregnancy tests, enrollment for all actors in the chain。
Live counts from ClinicalTrials.gov v2 API. Hot = 15+ recruiting trials. Active = 5-15. Quiet = <5. Dead = 0-2. Paradox = many trials but no FDA approval (investigate why).
For each drug: which countries approved it, which rejected, which have pending applications. Identifies opportunity markets where the drug has never been filed.
Patent & exclusivity dates, listed patents, approved dosage forms. Public record.
Package-level drug listing, labelers, marketing status. Live via openFDA API.
Core compound patents, formulation patents, prosecution history. Public search.
Schedule I-V classification, production quotas, import/export rules.
EU, Canadian, Australian, Japanese approval status. Public regulator databases.
Live trial counts by status, phase, sponsor, indication. Updated daily.
Every generic challenge. Who filed, what patent, outcome. The legal battlefield before the cliff.
Originator revenue models. When do revenues drop? What's the generic price erosion curve?
Extend PharmaVault to 510(k) devices, PMA devices, biologic/device combinations.
iPLEDGE, ETASU programs, restricted distribution mechanics. What happens at the cliff for restricted drugs.
Phase 1/2/3 split for each drug's research pipeline. Where is the most innovation happening?
Is research accelerating or decelerating for each drug? Plot the volume of new trials per year.