LogoFormulary

PDUFA Date

09/2025

Patent Cliff

Adalimumab

Phase III Readout

Q4 2025

BLA Submission

Ustekinumab

Biosimilar Launch

Denosumab

IND Filing

MOA: PD-L1

FORMULARY INTELLIGENCE PLATFORM · SECURE CHANNEL ACTIVEMay 30, 2026 · 08:39 PM EST

The formulary decisions your
competitors make next quarter — visible now.

Formulary parses FDA filings, patent cliffs, and pipeline catalogs into actionable drug-launch timelines — before the street prices them in. Built for hospital pharmacy directors, managed-care pharmacists, and biotech BD leads.

74 biosimilars tracked
$230B patent cliff mapped
No credit card required
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01 // THE_SIGNAL_PROBLEM

Every morning, the FDA publishes
hundreds of filings.

NDAs, BLAs, ANDAs, sNDAs, patent certifications, interchangeability designations — a continuous flood of regulatory signal that takes institutional teams days to parse. Most formulary decisions are made on data that's already weeks stale.

RAW FDA ACTIVITY STREAM — LIVE
fda_firehose.log — 847 entries today
LIVE
NDA 216498 — Lecanemab — Biogen/Eisai — Alzheimer's — Priority Review
BLA 761234 — Subcutaneous Pembrolizumab — Merck — NSCLC — Standard
ANDA 091847 — Rosuvastatin 40mg — Aurobindo — Cardiovascular
BLA 761301 — Denosumab-bbdz (Jubbonti) — Sandoz — Osteoporosis
NDA 217543 — Semaglutide Oral 25mg — Novo Nordisk — T2DM — Breakthrough
ANDA 092341 — Apixaban 5mg — Torrent — Anticoagulant — ANDA
BLA 761289 — Ustekinumab-auub (Wezlana) — Amgen — Psoriasis — Interchangeable
NDA 216701 — Tarlatamab — AstraZeneca — SCLC — Accelerated Approval
ANDA 093012 — Rivaroxaban 20mg — Sun Pharma — DVT Prevention
BLA 761318 — Omalizumab-qlyo (Omlyclo) — Cipla — Asthma — Interchangeable
NDA 217022 — Imetelstat — Geron — MDS — Priority Review
ANDA 091923 — Sitagliptin 100mg — Hikma — T2DM — First-to-File
BLA 761344 — Daratumumab SC 1800mg — J&J — Multiple Myeloma
NDA 216889 — Suzetrigine — Vertex — Pain — Breakthrough Therapy
ANDA 092788 — Sacubitril/Valsartan 97/103mg — Teva — Heart Failure
BLA 761267 — Ravulizumab — Alexion — PNH — Standard Review
NDA 217199 — Izokibep — Acelyrin — PsA — Fast Track
ANDA 093156 — Upadacitinib 15mg — Aurobindo — RA — Paragraph IV
NDA 216498 — Lecanemab — Biogen/Eisai — Alzheimer's — Priority Review
BLA 761234 — Subcutaneous Pembrolizumab — Merck — NSCLC — Standard
ANDA 091847 — Rosuvastatin 40mg — Aurobindo — Cardiovascular
BLA 761301 — Denosumab-bbdz (Jubbonti) — Sandoz — Osteoporosis
NDA 217543 — Semaglutide Oral 25mg — Novo Nordisk — T2DM — Breakthrough
ANDA 092341 — Apixaban 5mg — Torrent — Anticoagulant — ANDA
BLA 761289 — Ustekinumab-auub (Wezlana) — Amgen — Psoriasis — Interchangeable
NDA 216701 — Tarlatamab — AstraZeneca — SCLC — Accelerated Approval
ANDA 093012 — Rivaroxaban 20mg — Sun Pharma — DVT Prevention
BLA 761318 — Omalizumab-qlyo (Omlyclo) — Cipla — Asthma — Interchangeable
NDA 217022 — Imetelstat — Geron — MDS — Priority Review
ANDA 091923 — Sitagliptin 100mg — Hikma — T2DM — First-to-File
BLA 761344 — Daratumumab SC 1800mg — J&J — Multiple Myeloma
NDA 216889 — Suzetrigine — Vertex — Pain — Breakthrough Therapy
ANDA 092788 — Sacubitril/Valsartan 97/103mg — Teva — Heart Failure
BLA 761267 — Ravulizumab — Alexion — PNH — Standard Review
NDA 217199 — Izokibep — Acelyrin — PsA — Fast Track
ANDA 093156 — Upadacitinib 15mg — Aurobindo — RA — Paragraph IV

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SIGNAL OVERLOAD
FORMULARY INTELLIGENCE BRIEF — PARSED
PRIORITY BRIEF — IMMUNOLOGY
Feb 23, 2026 · 05:14 EST

Ustekinumab Biosimilar Switch Window: Action Required Before Q2 P&T Cycle

Formulary Impact: HIGHStelara · BLA 761289Interchangeable

FDA Interchangeability StatusWezlana (ustekinumab-auub) — CONFIRMED
Launch DateJanuary 1, 2025 — ACTIVE
PBM Formulary PositionBig Three leading with private-label biosimilars
Savings OpportunityUp to 85% off reference biologic list price
Formulary Dossier StatusPRO ONLY
Competitor BD OverlapPRO ONLY

FORMULARY ACTION

Initiate P&T dossier for automatic substitution protocol. CVS Caremark precedent: 97% fill rate shift within 90 days of formulary preference change.

With Formulary — one brief, one decision, zero noise

02 // COMMAND_ACCESS_TIERS

What you see depends
on your clearance level.

Free tier surfaces enough to confirm the problem exists. Pro tier gives you the decision before the meeting starts.

FREE TIER
PRO TIER
INTELLIGENCE CAPABILITY
Free
Pro · 14-Day Trial
FDA INTELLIGENCE
PDUFA date calendar (rolling 90-day)
7-day lag
Real-time · Same-day filing
NDA/BLA/ANDA new filing alerts
Weekly digest
Instant push · Therapeutic filter
Complete Response Letter (CRL) tracker
200+ CRLs indexed · 2020–present
Priority Review & Breakthrough designations
Public list only
MOA analysis + formulary impact score
BIOSIMILAR INTELLIGENCE
Approved biosimilar registry (74 products)
Name + indication
Full dossier · Interchangeability · PBM status
Formulary preference tracking (Big 3 PBMs)
Live · CVS / ESI / OptumRx
Switch window recommendations
P&T cycle-aligned · Institution-specific
Savings modeling vs. reference biologic
Generic % range
WAC · ASP · Net-of-rebate modeling
PATENT CLIFF
Loss-of-exclusivity (LOE) timeline
2025 only
2025–2030 · $230B cliff mapped
Paragraph IV certification alerts
First-to-file tracker · 180-day exclusivity
Competitor BD overlap analysis
MOA cross-reference · Pipeline conflict map
PIPELINE INTELLIGENCE
Phase III readout calendar
Public ClinicalTrials.gov
Parsed + formulary impact pre-scored
Formulary dossier templates
P&T-ready · AMCP format · Auto-populated
Therapeutic area pipeline briefs
1 area · Monthly
All areas · Weekly · Push alerts
PLATFORM ACCESS
API access for EHR/GPO integration
REST · HL7 FHIR compatible
Seats & team collaboration
1 seat
Unlimited · Audit trail

No credit card. Institutional email required.

14-day full Pro access · Downgrade to Free anytime

After trial: Free tier available indefinitely · Pro from $349/month per institution · Enterprise pricing available

03 // INSTITUTIONAL_SIGNAL

The advantage measured
in days, not opinions.

0

Biosimilars tracked in real-time

$0B

Patent cliff revenue mapped

~0/yr

Average new drug approvals indexed

0%

Prescription shift after formulary preference (CVS precedent)

11 days aheadImmunology · Biosimilar Transitions

"We caught the Wezlana interchangeability designation 11 days before our PBM sent the formulary preference notice. That head start let us draft the P&T dossier before the meeting was even scheduled."


Dr. Rachel Kim, PharmD

Director of Pharmacy, Northfield Health System

6 weeks earlyCardiovascular · GLP-1 Pipeline

"The patent cliff timeline for Ozempic and Xarelto alone justified the subscription cost for our entire BD team. We had competitive intelligence on semaglutide generics six weeks before our therapeutic review."


Marcus Webb

VP Business Development, Arctus Biosciences

14 switches reviewedFormulary Management · Oncology

"Building formulary dossiers used to take my team three days per drug. The AMCP-formatted templates pre-populated with FDA data cut that to four hours. We reviewed 14 biosimilar switches last quarter alone."


Sandra Okonkwo, PharmD, MBA

Managed Care Pharmacy Director, Meridian Health Plan

SAMPLE INTELLIGENCE BRIEF

Patent Cliff 2025–2026:
The $14.8B Cardiovascular Window

Entresto LOE July 2025 · Xarelto 2026 cliff · Ozempic generic pathway · Formulary positioning strategy for each transition. First 3 pages visible. Full 22-page dossier gated.

Institutional email required · No credit card

FORMULARY BRIEF — CARDIOVASCULAR — PAGE 4 OF 22
CLASSIFIED · PRO ACCESS REQUIRED
COMMAND ACCESS INITIALIZATION
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04 // INITIALIZE_ACCESS

See what's coming
before the street does.

14 days of full Pro access. Every PDUFA date, every biosimilar switch window, every patent cliff — parsed, prioritized, and delivered to your inbox. Downgrade to Free anytime. No friction.

Real-time FDA filing alerts
PDUFA date calendar · Same-day
Biosimilar interchangeability tracker
PBM formulary preference monitor
$230B patent cliff timeline 2025–2030
AMCP-formatted P&T dossier templates
Paragraph IV cert alerts
Unlimited therapeutic area coverage

Institutional email required · HIPAA-compliant infrastructure · SOC 2 Type II


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