Patent Cliff Tracker for the Pharmaceutical Industry

Every FDA-approved drug.
Every exclusivity date. Every country.

When does Semaglutide's patent expire? Is Tirzepatide approved in China? Is the BPC-157 research field still hot? PharmaVault answers the questions that decide billion-dollar moves — patent cliff timelines, global approvals, Paragraph IV litigation, REMS programs, and live research activity.

View the Cliff Timeline Who Uses This
Who This Is For

Built for the people who bet on pharmaceutical timelines

Five verticals. One platform. Each one is making decisions on incomplete data that this product fixes.

🏭
Generic Manufacturers
When a drug's patent cliff hits, you have 180 days of exclusivity to launch first-to-file. We surface the cliff date, the existing ANDAs, the active Paragraph IV litigation, and the Orange Book patent details.
The pain: Orange Book is opaque. 180-day exclusivity is hard to track. We make it visible.
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Biotech Investors
Originator revenue cliffs determine stock price. We track patent expirations across 9+ major drugs, plus research pipeline activity (Phase 2/3 trial counts, recruiting status, hot/dead/paradox signals).
The pain: 18-month cliff visibility is buried in 10-Ks. We make it instant.
⚖️
IP Lawyers & Hatch-Waxman Specialists
Paragraph IV litigation tracking. First-to-file exclusivity, 30-month stay calculations, settlement outcomes. We surface 11+ active PIV cases with the structured data you need.
The pain: Court records are scattered. We aggregate them.
🏛️
Regulatory Affairs
iPLEDGE REMS programs. DEA scheduling. NDA vs ANDA approval pathways. We have 6+ REMS programs documented with full participant counts and compliance mechanisms.
The pain: FDA REMS pages are 50-page PDFs. We make them queryable.
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Pharma Compliance / Sunshine Act
Open Payments compliance requires HCP credential verification before payment. We integrate with the same Verify engine that powers our directory family.
The pain: Manual NPI lookups before every payment. We automate it.
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Pharma Consultants & Analysts
Sell-side research, buy-side due diligence, consulting decks. We give you the structured data that goes straight into your model — patent cliff years, ANDA filings, REMS programs, global approvals.
The pain: Manual data wrangling. We make it instant.
What We Track

8 dimensions of pharmaceutical intelligence

Each track is a separate structured data product. Together they form the complete picture of a drug's lifecycle.

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Patent Cliff Timeline
For every drug: when the last patent expires. Visual Gantt-chart timeline 2025-2040. Color-coded by urgency.
9 drugs
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Global Approvals
Where each drug is approved, in what indication, in what year. US, EU, UK, Canada, Japan, China, India, Australia.
32 country-drug combos
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Paragraph IV Litigation
ANDA filings, first-to-file, 180-day exclusivity, settlement outcomes. The legal battlefield before the cliff.
11 cases tracked
⚠️
REMS Programs
Risk Evaluation and Mitigation Strategy programs. iPLEDGE, TIRF, Vyleesi, Qsymia, Suboxone, Testosterone class REMS. Full enrolled-participant counts.
6 programs
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Research Activity Radar
Live ClinicalTrials.gov data. Hot/Active/Quiet/Stale/Paradox signals. For every drug, every indication, the pipeline is visible.
27 drug-indication combos
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API Manufacturers
Who makes the active pharmaceutical ingredient. Indian, Chinese, US, EU suppliers. DMF filings, FDA inspections.
18 records
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Drug Master Files
DMF tracking, including Type II API DMFs and Type IV excipient DMFs. FDA inspection history, 483 observations where public.
Coming Q4
⚕️
Medical Device Cliffs
Extending beyond drugs: 510(k) and PMA patent cliffs for insulin pumps, CGMs, pacemakers, MitraClip, WATCHMAN.
10 devices tracked
Sample View

The patent cliff at a glance

Sample of our 9-drug coverage. Live data on global approvals, NDA exclusivity, and research activity.

Drug Indication Approved Patent Cliff Status Research
Semaglutide T2D / Obesity 2017 2033 Originator 🔴 92 recruiting (hot)
Tirzepatide T2D / Obesity 2022 2039 Originator 🔴 93 recruiting (hot)
Sildenafil ED / PAH 1998 2019 (passed) Generic 🟡 17 recruiting (active)
Finasteride BPH / Hair Loss 1992 2013 (passed) Generic 🟡 8 recruiting (active)
Enclomiphene Hypogonadism Not approved N/A Not approved 🔵 0 active (paradox)
Isotretinoin Severe Acne 1982 2002 (passed) Generic + iPLEDGE 🟡 14 recruiting
Testosterone Cyp Hypogonadism / TRT 1979 No patent Generic (Sched III) 🔴 43 recruiting (hot)
Bremelanotide HSDD (Women) 2019 2036 Originator (Women) ⚪ 0 (stale)

Plus 1 more drug (Clomiphene Citrate, 1967-approved, fully generic, $0.10-$0.30/pill). View all 9 →

The numbers behind PharmaVault

We started with ourselves. PharmaVault runs in production across our directory family and consulting work.

9
Drugs tracked end-to-end
32
Country-drug combinations
11
Active PIV cases
27
Research activity records

Every data point is sourced from public records (FDA Orange Book, ClinicalTrials.gov, openFDA, state boards) and timestamped with a SHA-256 evidence hash. We're built to be auditable.

Get in touch

PharmaVault is currently in private beta. We're working with a small group of generic manufacturers, biotech investors, and regulatory affairs teams. Reach out for early access.

Request Beta Access Data Partnership