Competitive Intelligence · First-to-File Generics · The 2026 Patent Cliff
A systematic map of first-to-file generic opportunities arising from the 2025–2028 patent cliff — Para IV filings, 180-day exclusivity windows, FTO analysis, and the companies best positioned to capture value.
Brand revenue at risk 2025–2028
US market only
Blockbusters losing exclusivity
Primary patent expiry 2025–2028
Para IV filings tracked
Active FTF challenges as of Q1 2026
FTF exclusivity window value
Avg. FTF profit: $40–200M per drug
High-value targets (>$1B brand rev)
FTF opportunity > $80M estimated
Peak cliff year
Largest single-year exclusivity loss wave
| Scope | 85+ small-molecule brand drugs losing primary US patent exclusivity between 2025 and 2028 — with active or anticipated Para IV challenges mapped |
|---|---|
| Top Therapeutic Classes | Immunology / Biologics (small-mol analog)Oncology oralDiabetes / MetabolicCardiovascularCNS / NeurologyRespiratory |
| FTF Complexity Drivers | Patent thickets (10–30 patents)Pediatric exclusivity extensionsCitizen petitions (delay tactics)NCE 5-year exclusivitySettlement / reverse payment risk |
| Top FTF Filers | Teva · Mylan (Viatris) · Sun Pharma · Apotex · Hikma · Aurobindo · Amneal · Sandoz (Hexal) · Dr. Reddy's · Lupin |
| Regulatory Path | ANDA (Para IV) filing → 30-month stay → litigation → settlement or district court ruling → 180-day exclusivity clock starts |
Pipeline Drugs · All Disclosed Assets
| Drug Name | Company | Modality | Indication | Stage | Mechanism |
| Eliquis (apixaban) | BMS / Pfizer vs. Teva et al. | Small molecule | Anticoagulation | Patent cliff 2026 | ~$12B US revenue at risk · FTF exclusivity highly contested |
| Xarelto (rivaroxaban) | Bayer / J&J vs. Mylan et al. | Small molecule | Anticoagulation | Patent cliff 2027 | ~$4.5B US revenue · Multiple Para IV challengers |
| Ibrance (palbociclib) | Pfizer vs. Sun et al. | Small molecule | Breast Cancer | Patent cliff 2027 | ~$3.8B US revenue · Composition patent expires 2027 |
| 🔒 Top FTF Asset A | Multiple challengers | — | Locked | 2026 cliff | Details in paid report |
| 🔒 85+ more drugs... | Multiple brands | — | Various | 2025–2028 | Full landscape in paid report |
A systematic map of first-to-file generic opportunities arising from the 2025–2028 patent cliff — Para IV filings, 180-day exclusivity windows, FTO analysis, and the companies best positioned to capture value.
Full Report
$79
one-time · single report
Deep-Dive
$399
one-time · full analysis
Platform
$1,499/mo
team access · all reports
Fill in your details and we'll send the report to your inbox within 48 hours.