Loss of exclusivity tracking that gives every product and market a cited generic entry date — within hours of any change
A cited generic entry date per market within hours of any change.
See one case, screen by screen ↓Loss of exclusivity (LOE) tracking keeps, for each product and market, the date a generic or biosimilar can launch and what could move it. Loss of Exclusivity Tracking maps every patent, term extension, pediatric extension, regulatory exclusivity, challenger and settlement term to a cited entry date, watches the sources that move it, and recomputes the date and its downside case within hours of a change.
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The day a generic or biosimilar can launch is not a patent expiry. It is the earlier of a settled licensed entry date and the end of the last barrier an unsettled challenger still faces — the base patent terms, term extensions (PTE or SPC), pediatric extensions, regulatory exclusivities, litigation, PTAB and EPO proceedings and the acceleration clauses in each settlement. IP strategy keeps that stack in a patent-term spreadsheet per product, refreshed for the annual plan, while docket alerts arrive from outside counsel by e-mail and the settlement terms sit in the contract system where only a few lawyers read them.
The date moves on events no annual spreadsheet watches: a PTAB institution, a Paragraph IV letter, a pediatric grant, an EPO opposition, a third party's launch that triggers an acceleration clause. By spreadsheet a change takes about three weeks to reach a decided date of record, and it reaches Finance as a slide. Meanwhile the 45-day window to sue on a Paragraph IV notice runs from the day the letter arrives — miss it and the 30-month stay is lost.
Estimated split for one source event by spreadsheet and with the solution; the total of about three weeks by spreadsheet is the team estimate shown in the working solution.
Six specialist agents watch the sources, read every decision, recompute entry dates and keep the legal clocks; the chief patent counsel decides.
Northwind Bio has four products in eight markets. On Oct 2 the PTAB institutes inter partes review of the '418 once-daily formulation patent on Corventa, a $4.2B-a-year heart-failure tablet. Here is what happens next, screen by screen, in the working solution.
Each product and market is a lane from today to its expected generic or biosimilar entry, revenue on the right: Corventa US Mar 2036, Veltrimab US Jan 2033, Talmirex US Aug 2027, Orvessa Nov 2038. Beside the lanes, six statutory clocks count down in days, hours, minutes and seconds — the nearest is the 45-day suit window on Brightwell Pharma's notice, due Nov 19, 2026. Across all 32 product-markets, $28.8B of revenue is at risk.
Latest source event · PTAB docket · picked up Oct 2, 17:42: “Inter partes review instituted on all 14 claims of Corventa’s ’418 once-daily formulation patent.”
“Show the effect on the horizon” focuses the Corventa US lane. The downside appears in red: generic entry Sep 15, 2033 if the '418 is cancelled at the PTAB and the '772 is lost at trial in January, because then the six settled filers accelerate. The date of record holds at Mar 1, 2036, and the patent owner response clock lights up.
“Likelihood proposed 20% → 40% · $7.6B of US revenue at risk · date of record holds at Mar 1, 2036.”
Every figure on the lane cites its source. The acceleration citation opens the Arden Generics settlement at section 3.3: the licensed entry date moves earlier only if a third party starts selling a generic after a final court decision holding each asserted claim of both the '418 and the '772 invalid, unenforceable or not infringed. The agreement is marked Legal only, and five more are on substantially identical terms.
The Settlement Terms Reader quotes the clause and never paraphrases a trigger.
The Source Watcher picked up the institution decision from the PTAB docket feed at 17:42. The Patent & Exclusivity Reader confirmed claims 1–14 are under review on all grounds, with the patent owner response due Jan 4, 2027 and the final written decision by Oct 2, 2027. The Settlement Terms Reader re-read six agreements. The Entry Date Calculator found the downside now needs only the '772 trial to go against Northwind, and the Clock Keeper added two clocks.
“Waiting for Omar Haddad — Chief Patent Counsel decides the date of record and the downside likelihood.”
Keep Mar 1, 2036 as the US date of record — the settled filers' date stands unless both the '418 and the '772 fall in final decisions. Raise the downside case, entry Sep 15, 2033 when the compound patent and its pediatric exclusivity end, from 20% to 40%, because one of the two required outcomes is now in a forum where challengers often win. Each part links to its source.
“Decides: Omar Haddad, Chief Patent Counsel · an agent proposes, a person decides.”
Omar could keep the downside at 20% or ask Dana Okafor for the litigation view first. He accepts. The change moves to Date of record, then Sent to Finance: Sam Patel is notified and the long-range plan's exclusivity feed is updated. Undo stays one click away, and the undo is logged too.
“Sent to Finance — Sam Patel notified; LRP exclusivity feed updated.”
The Corventa US map lays out the stack: the '207 compound patent with its PTE capped at 14 years, new chemical entity exclusivity ended Mar 2024, the '772 method of use in litigation with trial on Jan 11, 2027, the '418 formulation under IPR, the '903 process patent not asserted. The settlement line binds. The chain on the right shows the reasoning: a challenger without a licence can enter when the last barrier ends, Feb 21, 2038; the settled filers enter Mar 1, 2036; entry is the earlier of the two.
Switching on “'418 claims cancelled in the IPR” and “'772 held invalid at trial” turns the settlement line to “Acceleration triggered”. Entry becomes Sep 15, 2033 — 2 years 6 months earlier than the date of record, set by the '207 compound patent with its PTE and pediatric extension. The case can be saved as a scenario or sent to Finance.
“Settled filers' licensed entry: Mar 1, 2036 — brought forward to Sep 15, 2033 by the acceleration clause.”
Since Sep 16, eight source events touched a date, a downside or a clock; the other 15 events of the last 90 days changed nothing and were closed by the agents. Dana owns the Brightwell Pharma Paragraph IV notice: dated Oct 2, received by courier Oct 5, so the suit deadline is Nov 19, 2026. The recommendation is to sue on the '772 and '418 and join the Halvard and Ivel action. A timely suit stays approval to Apr 5, 2029, and Brightwell's paragraph III certification on the '207 already holds it back to Sep 15, 2033.
The Clock Keeper counts from the received date, never the letter date, and escalates to the Chief Patent Counsel at 7 days.
The Board Summary Writer collects the dates of record for 32 product-markets, reads the 8 changes since Q3 and checks the 6 clocks. Its headline: one date of record moved — Veltrimab in Japan, from Dec 2030 to Oct 2032 — and the Corventa US downside is now carried at 40%. Every figure links to its source, and the summary waits for counsel's signature.
Only decided dates of record appear as dates, and counsel signs before the summary leaves Legal.
The same Corventa change, seen by the five people who carry it — what their quarter looked like, and what it looks like now.
Six specialist agents watch the sources, read every decision, recompute entry dates and keep the legal clocks; the chief patent counsel decides.
Watches USPTO patent status and term extensions, the PTAB and court dockets, the FDA Orange Book and Purple Book, the Paragraph IV list, the EPO Register, national SPC registers and the JPO and CNIPA gazettes. It matches each entry to a product and market and opens a change with the source document attached.
Reads decisions, certificates, letters and listings for claim type (compound, formulation, method of use, process or device), expiry, PTE, SPC and pediatric terms and proceedings. It applies the 14-year PTE cap and the 15-year SPC cap and shows the arithmetic.
Reads settlement and licence agreements for the licensed entry date, every acceleration trigger, volume limits, territory and FTC filing. When a change touches a licensed patent, it re-checks which triggers the change could satisfy.
Recomputes expected entry per product and market: the earlier of the settled licensed date and the end of the last barrier a non-settled challenger faces, extensions and pediatric terms included. It records the binding barrier, the downside case and the revenue at risk from the long-range plan, and runs every scenario.
Computes the statutory clocks — the 45-day suit window, the 30-month stay, IPR responses, the biosimilar patent exchange, PTE and SPC filing windows — assigns each an owner from Settings and alerts at 30, 14 and 7 days.
Drafts the quarterly loss-of-exclusivity summary for the executive committee in six sections — headline, dates of record, what changed, what could move a date, decisions and clocks, revenue under exclusivity — with every figure linked to its source.
Decides the date of record. The agents propose; a named person decides.
Ask what could move a date or which clocks are running, or add an alert rule in plain words. Every answer cites its source.
Why is Corventa's US entry March 2036?
Because six challengers settled for a licensed entry date of Mar 1, 2036, and the three that did not settle are blocked longer — by the '772 method-of-use patent to May 2, 2036 and the '418 formulation patent to Feb 21, 2038, both with pediatric exclusivity. The date moves only if both patents fall in final decisions; then the settled filers accelerate and entry becomes Sep 15, 2033.
What happens if the IPR cancels the '418?
The PTAB instituted review of all 14 claims of the '418 on Oct 2; a final decision is due by Oct 2, 2027 and our response by Jan 4, 2027. Cancelling the '418 alone does not move the date: the '772 still blocks unlicensed filers to May 2036, later than the settled Mar 1, 2036. It matters together with the '772 trial.
Show the Veltrimab downside in the US
In the downside, biosimilars clear the '880 process, '613 treatment and '036 formulation patents. The last barrier is then the antibody patent with its capped extension — Jul 14, 2031 — instead of the settled Jan 31, 2033, and Kestrel and Marlowe would accelerate too.
Add a rule: alert me if any settlement acceleration could trigger
Done. Every decision on a licensed patent and every third-party launch is now watched, with an alert the same hour if a settled filer's acceleration clause could trigger — as section 3.3 of the Corventa settlements would after final decisions on both the '418 and the '772. The rule is on in Settings and on the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
How entry dates are computed, who decides and when you are alerted are settings. Change a calculation rule and every date recomputes.
| Setting | Default | Choose from |
|---|---|---|
| Count pediatric exclusivity | Once granted | Once granted · Once the written request is accepted |
| Generic launch assumption | On the day the last barrier ends | On the day the last barrier ends · 30 days after · 90 days after |
| Downside case | Every open challenge decided against us | Every open challenge decided against us · Only challenges already instituted or tried |
| Revenue at risk uses | LRP v3 · Sep 26, 2026 | LRP v3 · Sep 26, 2026 · LRP v2 · Jun 2026 |
| Who decides the date of record | Omar Haddad | Omar Haddad · Dana Okafor · Priya Raman · Sam Patel · Lena Ortiz · Dr. Maya Chen |
| Who decides suits and statutory clocks | Dana Okafor | Omar Haddad · Dana Okafor · Priya Raman · Sam Patel · Lena Ortiz · Dr. Maya Chen |
| Alert when a date of record would move by three months or more | On — goes to the Chief Patent Counsel the same day | On · Off |
| Clock reminders at 30, 14 and 7 days | On — the owner, then the Chief Patent Counsel at 7 days | On · Off |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample portfolio · “target” = the design goal, measured in the live solution · “estimated” = our estimate; about three weeks by spreadsheet is a team estimate · “typical” = set by statute: 21 USC 355(j) (45-day suit window, 30-month stay), 35 USC 156 (14-year cap on patent term extension), EU Regulation 469/2009 (supplementary protection certificates). People, companies, products, patents and challengers named on this page are fictional — characters and sample data in the working solution.
Loss of exclusivity (LOE) tracking keeps, for each product and market, the date a generic or biosimilar can launch and what could move it. Loss of Exclusivity Tracking maps every patent, term extension, pediatric extension, regulatory exclusivity, challenger and settlement term to a cited entry date, watches the sources that move it, and recomputes the date and its downside case within hours of a change.
The Entry Date Calculator takes the earlier of the settled licensed entry date and the end of the last barrier an unsettled challenger still faces, with extensions and pediatric terms included. The Patent & Exclusivity Reader applies the 14-year PTE cap and the 15-year SPC cap and shows the arithmetic, and every proposed date names the barrier that binds it.
A notice letter arriving in the legal mailbox becomes a change. The Patent & Exclusivity Reader records which patents are challenged, and the Clock Keeper counts the 45-day window from the courier receipt, not the letter date, assigns it to litigation counsel and reminds at 30, 14 and 7 days. Litigation counsel decides whether to sue.
Yes. It carries the 12-year reference product exclusivity, the biosimilar patent exchange and its 60-day patent list, biosimilar settlements and their acceleration clauses. In the working solution, a biosimilar application accepted by FDA becomes a change with the patent list clock running to its due date.
Only decided dates. Finance receives the date of record and the downside case per market once the Chief Patent Counsel decides, and the long-range plan feed is updated at that moment. Settlement terms themselves stay visible to Legal roles only.
Yes. The agents compute, cite, count and propose; they never file, sue or reply, and never set a date of record. The Chief Patent Counsel decides the date and the downside likelihood, every decision can be undone, and both the decision and the undo are on the audit trail.
Yes. When pediatric exclusivity counts, the generic launch assumption after the last barrier, what the downside case assumes, the revenue basis, the sources watched, the alert rules and who decides each kind of change are all settings. Change a calculation rule and every date recomputes.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your patent family records, listings, settlements and long-range plan assumptions — and it goes live once every quality gate has passed. We will walk you through it on your own portfolio first.
The 45-day clock set and a cited response pack ready the same day.
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1-min demoWe'll run Loss of Exclusivity Tracking on your own patent estate, settlements and listings.