Agent skill

Orange Book Loe

by hh-health-AI in hh-health-AI/healthcare-equity

This skill should be used when the user asks about "LOE", "loss of exclusivity", "patent cliff", "when does [drug] go generic", "Orange Book", "Paragraph IV", "patent expiry", "generic entry date"…

MITAuto-check passedLegal & Compliance

Install Orange Book Loe

skills CLI
$ npx skills add hh-health-AI/healthcare-equity --skill orange-book-loe -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install hh-health-AI/healthcare-equity orange-book-loe --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/hh-health-AI/healthcare-equity.git skills-src && mkdir -p .claude/skills && cp -r skills-src/modules/ip-exclusivity/skills/orange-book-loe .claude/skills/orange-book-loe && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
orange-book-loe
GitHub stars
101
Token cost
~1k tokens
SKILL.md length
518 words
Files
2 (incl. references)
Skills in repo
72
Repo updated
First seen
Licence
MIT

At a glance

This skill should be used when the user asks about "LOE", "loss of exclusivity", "patent cliff", "when does [drug] go generic", "Orange Book", "Paragraph IV", "patent expiry", "generic entry date"…

  • Works in 9 steps: Resolve the brand to Orange Book… → Stack the patents and classify each one.… → Stack the exclusivities. NCE, ODE,… → …
  • Loss of exclusivity
  • SKILL.md covers Workflow, Traps and Not-automatic
  • Instructions only: no scripts, shell commands, URLs or credentials in SKILL.md

What it does

Orange Book Loe is an agent skill from hh-health-AI/healthcare-equity. This skill should be used when the user asks about "LOE", "loss of exclusivity", "patent cliff", "when does [drug] go generic", "Orange Book", "Paragraph IV", "patent expiry", "generic entry date", or needs the exclusivity date that sets the terminal value in a pharma model. Anchors prompt-library ID MOD-04.

Its SKILL.md is about 1k tokens, which your agent loads only when the skill is triggered. The skill folder holds 2 other files, including reference files (for example `references/exclusivity-mechanics.md`).

It sits in Legal & Compliance, covering Intellectual property and Prompt engineering. The repository describes itself as: Synthesis engine for buy-side healthcare equity research. The licence is MIT.

When your agent uses it

  • Loss of exclusivity
  • Does [drug] go generic
  • Generic entry date
  • Needs the exclusivity date that sets the terminal value in a pharma model

Example prompts

  • “loss of exclusivity”
  • “patent cliff”
  • “when does [drug] go generic”
  • “/orange-book-loe”

Workflow steps

9 steps, taken from the first numbered list in SKILL.md.

  1. Resolve the brand to Orange Book application numbers. One brand may span several
  2. Stack the patents and classify each one. For every listed patent record
  3. Stack the exclusivities. NCE, ODE, NPP/NP, paediatric extension. Note that
  4. Find the Paragraph IV filings. FDA publishes the Paragraph IV certification
  5. Go and find the settlement. Search the sponsor's 10-K legal proceedings and
  6. Check PTAB. Run ptab-ipr-monitor on the key patents. An instituted IPR on the
  7. Produce the distribution. Three dated scenarios with rough probabilities
  8. Hand to valuation. State the terminal-value consequence directly: which years
  9. Emit the brief.

What it can do on your machine

Read from SKILL.md and the folder at commit 6c7bda8. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    No scripts in the folder and no shell commands in SKILL.md.

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

Orange Book Loe loads about 1k tokens when it runs, and up to ~1.8k if it reads all its reference files. Until then it costs about 81 tokens; SKILL.md has 518 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~81
When it runs · the whole SKILL.md, loaded when a task matches
~1k
With references · SKILL.md plus every file in references/, read only if the agent opens them
~1.8k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); files beside SKILL.md are not scanned.

SKILL.md

The full file from hh-health-AI/healthcare-equity at commit 6c7bda8, republished under its MIT licence (© hh-health-AI). 518 words, ~1,046 tokens.

Download SKILL.mdSave it as .claude/skills/orange-book-loe/SKILL.md (or your agent's skills folder). This skill also uses 1 other file; get the full folder from GitHub.
name
orange-book-loe
description
This skill should be used when the user asks about "LOE", "loss of exclusivity", "patent cliff", "when does [drug] go generic", "Orange Book", "Paragraph IV", "patent expiry", "generic entry date", or needs the exclusivity date that sets the terminal value in a pharma model. Anchors prompt-library ID MOD-04.
metadata.version
0.1.0
metadata.layer
Competitive

Orange Book LOE build

Construct the loss-of-exclusivity date for a brand as a distribution with named constraints, not as a single looked-up number.

Workflow

  1. Resolve the brand to Orange Book application numbers. One brand may span several NDAs (different strengths, formulations, delivery systems). Run scripts/orange_book_loe.py --brand X after downloading the current Electronic Orange Book zip; the script parses products.txt, patent.txt and exclusivity.txt and joins them on appl_no + product_no.
  2. Stack the patents and classify each one. For every listed patent record:
    • Expiry date, including any patent-term extension already reflected.
    • Drug substance flag (composition of matter) — the hard constraint.
    • Drug product flag (formulation) — designable-around, medium strength.
    • Use code (method of use) — weakest; a generic can carve the indication out with a skinny label under §viii and enter for the remaining indications.
    • Delisting requested — a signal the sponsor has conceded the patent.
  3. Stack the exclusivities. NCE, ODE, NPP/NP, paediatric extension. Note that paediatric exclusivity attaches on top of both patents and other exclusivities, which is why it so often is the binding date.
  4. Find the Paragraph IV filings. FDA publishes the Paragraph IV certification list with the date of first filing. First filing starts the clock: a first applicant may hold 180-day generic exclusivity, and the date of first filing plus the 30-month stay is the earliest structurally plausible entry.
  5. Go and find the settlement. Search the sponsor's 10-K legal proceedings and 8-Ks for the molecule name and "settlement", "agreement", "authorised generic", "entry date". Settlements routinely set entry years before nominal expiry, and are the single largest source of error in models built from the Orange Book alone. If no settlement is disclosed, say so explicitly — that is itself information.
  6. Check PTAB. Run ptab-ipr-monitor on the key patents. An instituted IPR on the composition-of-matter patent is a material probability shift.
  7. Produce the distribution. Three dated scenarios with rough probabilities:
    • Earliest plausible: Paragraph IV first-filing + 30-month stay, or a disclosed settlement date, or a successful IPR outcome.
    • Base: the constraint you actually believe binds, with the reason.
    • Nominal: latest listed patent plus paediatric, i.e. the number a naive model uses.
  8. Hand to valuation. State the terminal-value consequence directly: which years of cash flow move, and what the DCF is worth under each scenario. your view layer → model-valuation owns the model; this skill owns the date and the reason.
  9. Emit the brief.
Show full SKILL.md (122 more words)Show less

Traps

  • Authorised generics. The brand can launch its own generic at entry, retaining material profit. A model that zeroes the franchise at LOE overshoots.
  • Non-substitutable formulations. Devices, depots, and combination products erode far more slowly because pharmacy-level substitution does not apply.
  • Ex-US expiry differs. European SPCs and Japanese exclusivity run on their own calendars. global-access owns those; do not assume the US date applies globally.
  • Delisting and reverse payments. Watch FTC actions on pay-for-delay; a challenged settlement can be re-opened.

Not-automatic

An Orange Book patent stack does not license an entry-date conclusion on its own — without the settlement search and the Paragraph IV list, the date is the nominal one, which is usually wrong and always too late.

Reference: references/exclusivity-mechanics.md. Contract: ../../references/evidence-brief.md.

© hh-health-AI, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 1 other file (references) in modules/ip-exclusivity/skills/orange-book-loe of hh-health-AI/healthcare-equity.

  • SKILL.md
  • references/exclusivity-mechanics.md

Open the folder on GitHubat commit 6c7bda8

Compare with similar skills

Orange Book Loe next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.

Orange Book Loe compared with similar skills
SkillStarsUsed inTokensAuto-checkLicenceRepo updated
Orange Book Loe this skillhh-health-AI/healthcare-equity101—~1kAutomated safety check: PassMIT
Seedance IP-Safe Prompt RewriterEmily2040/seedance-2.07.6k1 repos~930Automated safety check: PassMIT
Paper to Chinese Patent DrafterYuan1z0825/nature-skills47k1 repos~1.1kAutomated safety check: PassApache-2.0
Paper To Cn Patentsnipp-zha/Paper-to-patent-Skill1071 repos~959Automated safety check: PassNone
Patent Examinegfodor/legal-skills393—~4.8kAutomated safety check: PassGPL-3.0
Patent Auditgfodor/legal-skills393—~2.9kAutomated safety check: PassGPL-3.0

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Questions about Orange Book Loe

What does Orange Book Loe do?

This skill should be used when the user asks about "LOE", "loss of exclusivity", "patent cliff", "when does [drug] go generic", "Orange Book", "Paragraph IV", "patent expiry", "generic entry date"…. Orange Book Loe is an agent skill from hh-health-AI/healthcare-equity. This skill should be used when the user asks about "LOE", "loss of exclusivity", "patent cliff", "when does [drug] go generic", "Orange Book", "Paragraph IV", "patent expiry", "generic entry date", or needs the exclusivity date that sets the terminal value in a pharma model.

When should I use Orange Book Loe?

Orange Book Loe fits situations like: loss of exclusivity; does [drug] go generic; generic entry date; needs the exclusivity date that sets the terminal value in a pharma model.

How do I install Orange Book Loe in Claude Code?

Run `npx skills add hh-health-AI/healthcare-equity --skill orange-book-loe -a claude-code`. Or copy the skill folder (modules/ip-exclusivity/skills/orange-book-loe in hh-health-AI/healthcare-equity) into .claude/skills/orange-book-loe in your project. Claude Code loads it when a task matches its description.

How do I install Orange Book Loe in Codex?

Run `npx skills add hh-health-AI/healthcare-equity --skill orange-book-loe -a codex`. Or copy the skill folder (modules/ip-exclusivity/skills/orange-book-loe in hh-health-AI/healthcare-equity) into .agents/skills/orange-book-loe in your project. Codex loads it when a task matches its description.

Can I use Orange Book Loe in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add hh-health-AI/healthcare-equity --skill orange-book-loe -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/orange-book-loe, .gemini/skills/orange-book-loe, .github/skills/orange-book-loe and .opencode/skills/orange-book-loe in your project.

What does Orange Book Loe need to run?

SKILL.md names no scripts, command-line tools or credentials: Orange Book Loe is instructions for the agent only.

Does Orange Book Loe access the network?

SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.

Is Orange Book Loe safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. Review the folder before installing.

What licence does Orange Book Loe use?

Orange Book Loe is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does Orange Book Loe use?

About 1k tokens (SKILL.md is roughly 4.2k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 775 tokens, read only when the agent opens those files.

What are the alternatives to Orange Book Loe?

Skills that share tags, products or a category with Orange Book Loe: Seedance IP-Safe Prompt Rewriter (Emily2040/seedance-2.0, 7.6k stars), Paper to Chinese Patent Drafter (Yuan1z0825/nature-skills, 47k stars), Paper To Cn Patent (snipp-zha/Paper-to-patent-Skill, 107 stars) and Patent Examine (gfodor/legal-skills, 393 stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains Orange Book Loe?

hh-health-AI (a GitHub user) maintains it in hh-health-AI/healthcare-equity, which has 101 GitHub stars. The repository holds 72 skills in this directory. The repository was last updated on October 8, 2026.

Source: hh-health-AI/healthcare-equity on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.