TheraRadar
Patent landscape

Vasopressin In Sodium Chloride 0.9% (vasopressin)

Baxter · Targets: V1 receptor, V2 receptor · First FDA approval 2023-09-29
Orange Book + BigQuery Patent data as of 2026-05-15
Orange Book listed
1
1 family
Global footprint
1
across 1 countries
Multiplier
intl docs / OB patents
Cliff closes
Sep 26, 2044
Last US OB patent falls
Cliff opens
Sep 29, 2043
Foundational composition expiry
Cliff window: opens Sep 29, 2043 (foundational composition expires) and closes Sep 26, 2044 (last US OB patent falls). Generic entry timing depends on Hatch-Waxman settlements — the first ANDA filer often trades a 180-day exclusivity for a delayed-entry agreement months to years past the patent expiry.

Patent portfolio

Family-by-family interpretation: which family anchors composition, which add lifecycle, when each expires.

The patent estate for vasopressin in sodium chloride 0.9% consists of one Orange Book-listed patent corresponding to a single patent family. The global footprint is highly concentrated, comprising only one international document across one country, indicating a strictly US-focused intellectual property strategy by Baxter.

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Orange Book patent stack

1 unique patents listed against this drug. All mapped to BigQuery patent families.

Patent Family Claim type Use code US expiry
US 12447190 97404628 Sep 27, 2044

Patent families — global footprint

Family-deduplicated portfolio across all jurisdictions. Each family represents a single invention with related filings in multiple countries.

Pro Patent families — global footprint — Country-by-country lists, family-level priority dates, continuation patterns across all jurisdictions
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International vs US — composition family

Most jurisdictions follow priority + 20 years. US adds Patent Term Adjustment (PTA); EU adds Supplementary Protection Certificate (SPC); Japan adds Patent Term Extension (PTE). Latest US Orange Book expiry includes these extensions.

Priority date
2023-09-29
Family 97404628
Nominal global expiry
2043-09-29
priority + 20 years
Latest US OB expiry
2044-09-26
includes US PTA

Coverage status

What this page covers, what's coming in a future refresh, and what's out of scope.

Category What's covered Status
Orange Book patents 1 unique patents listed; 1 resolved to BigQuery families (100%) Complete
Same-family international 1 documents across 1 countries via BigQuery family expansion Complete
Nominal international expiry Priority date + 20 years computed per family. Composition family nominal expiry: 2043-09-29. Complete
Estate analysis LLM-generated structural analysis, constrained to patent data only — no commercial, financial, or litigation claims included Complete
Country-specific extensions EU SPC, JP PTE, KR PTE not modeled. US Orange Book expiry already includes US PTA. Most ex-US jurisdictions follow priority + 20 years (shown). Known limitation
Hatch-Waxman / BPCIA settlement terms Specific settlement terms (royalty %, launch dates) are confidential between parties Out of scope
Commercial / M&A history Deal terms, royalty stacks, contingent value rights — not in patent data Out of scope

Frequently asked

Common questions about Vasopressin In Sodium Chloride 0.9%'s patent landscape

When will generics enter the market for Vasopressin In Sodium Chloride 0.9%?
Nominal patent expiry shows the cliff window: Sep 29, 2043 (when the foundational composition patent expires) to Sep 26, 2044 (when the last US OB patent falls). In practice, generics typically enter mid-window via negotiated settlement — Hatch-Waxman settlements often produce delayed-entry agreements between the brand and the first ANDA filer, typically trading a 180-day exclusivity for an entry date months to years past the patent. Exact entry depends on patent challenges, design-around feasibility, and settlement negotiations.
What's the difference between "cliff opens" and "cliff closes"?
Cliff opens (Sep 29, 2043) marks Vasopressin In Sodium Chloride 0.9%'s foundational composition patent expiry — the earliest theoretical date for generic entry. Cliff closes (Sep 26, 2044) is when the last US patent in the thicket finally falls — after which the market has no patent-based barriers. The gap between these two dates is the lifecycle-extension window: secondary patents (formulations, methods of use, manufacturing) that can block generics even after the composition patent has expired.
Why is Vasopressin In Sodium Chloride 0.9% in the Orange Book?
Vasopressin In Sodium Chloride 0.9% is regulated via the FDA 505(b) NDA pathway for small-molecule drugs and listed in the FDA Orange Book (small molecules). Small-molecule NDA holders must list approved-use patents in the Orange Book under Hatch-Waxman. The patents shown here come directly from FDA Orange Book listings.
What's a patent family and why does it matter?
A patent family is a group of patent applications and grants worldwide that share the same priority filing (the earliest invention disclosure). One US patent often expands to 20–40+ filings across different jurisdictions — each grant in a different country protecting the same underlying invention. Vasopressin In Sodium Chloride 0.9% has 1 family that resolve to 1 international documents across 1 countries. Families matter because generic entry requires clearing patent barriers in each market separately — a US generic launch is independent of EU or Japan launches.
How were these Vasopressin In Sodium Chloride 0.9% patents identified?
Vasopressin In Sodium Chloride 0.9%'s 1 US patents come directly from the FDA Orange Book, which small-molecule NDA holders are required to list under Hatch-Waxman. We then expand each Orange Book patent to its full international family using the BigQuery patent family graph (priority date + global jurisdictions). The US patent list is FDA-authoritative.
What does the "Multiplier" stat mean?
The multiplier shows how many international patent documents exist for every US patent in Vasopressin In Sodium Chloride 0.9%'s thicket — calculated as 1 international documents ÷ 1 US patents = 1×. A high multiplier (>10×) indicates an aggressive global filing strategy — the sponsor has filed in many countries to maximize geographic protection. A low multiplier suggests the patent estate is US-centric, with limited international protection.

Methodology & data sources

  • Orange Book patents: FDA Orange Book via TheraRadar's fetch-orange-book.js, refreshed 2026-05-26.
  • Patent families & international docs: BigQuery patents-public-data.patents.publications, queried 2026-05-15. Seed lookup → family expansion → priority date aggregation.
  • Nominal global expiry: earliest priority_date per family + 20 years. Does not include country-specific extensions (US PTA, EU SPC, JP PTE).
  • Estate analysis: generated by gemini-3-pro-preview, constrained to structural patent data only. No commercial, financial, or litigation claims included.
Intelligence, not legal advice. Patent expiry shown is nominal where indicated; actual market timing depends on PTA/SPC/PTE, exclusivity overlays, pediatric extensions, IPR/PTAB outcomes, and Hatch-Waxman litigation. Consult patent counsel for precise jurisdiction-by-jurisdiction analysis.

TheraRadar Pro — patent intelligence

Free covers what's publicly listed: Orange Book patents, basic stats, composition expiry. Pro adds the deeper view: LLM-driven estate analysis, full international family thicket, and (coming soon) alerts + exports.

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  • Orange Book patent table (every patent, family, use code, expiry)
  • Stat strip — OB count, families, global doc footprint, multiplier
  • Composition family priority + nominal global expiry
  • International vs US expiry comparison
  • Coverage status + methodology
  • Cross-link to mechanism / class landscape
PRO

What Pro adds today

  • Estate analysis (sections 2-5) — Composition anchor, lifecycle layers, international vs US, strategic outlook
  • Full patent families table — Country lists, doc counts, priority dates per family
  • International nominal expiries — Priority + 20 years per family with global vs US gap
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Patent data updated: May 26, 2026