TheraRadar
Patent landscape

Humira (adalimumab)

AbbVie Inc. · Targets: TNF · First FDA approval 2002-12-31
Purple Book + BigQuery Patent data as of 2026-05-15
Curated patents
66
21 families
Global footprint
703
across 41 countries
Multiplier
11×
intl docs / curated patents
Cliff closes
Nov 13, 2034
Last US lifecycle patent falls
Cliff opens
Jun 8, 2021
Foundational composition expiry
Cliff window: opened Jun 8, 2021 (foundational composition expired) and closes Nov 13, 2034 (last US lifecycle patent falls). Biosimilar entry typically lands mid-window via negotiated settlement — Humira biosimilars entered ~7 years past composition expiry under licensing agreements with AbbVie.
International footprint: Curated thicket data identifies 66 US patents. BigQuery family expansion shows the same inventions filed as 703 documents across 41 countries in 21 patent families — 11× the US count.

Patent portfolio

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

The patent estate for adalimumab comprises 66 curated patents distributed across 21 patent families, yielding a substantial global footprint of 703 international documents across 41 countries. This represents a notable >10x multiplier of international documents to curated patents identified in TheraRadar's curated thicket, which are not FDA-authoritative as biologics are excluded from the Orange Book.

Pro Composition anchor, lifecycle layers, outlook — Remaining 4 sections of the estate analysis
See what Pro includes ↓

Orange Book patent stack

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

Patent Family Claim type Use code US expiry
US 8992926 23144283 June 5, 2022
US 8974790 23144283 June 5, 2022
US 8911737 23144283 June 5, 2022
US 9546212 23144283 June 5, 2022
US 6805686 33131506 May 6, 2023
US 9090689 37432217 July 18, 2023
US 9085620 37432217 July 18, 2023
US 9067992 37432217 July 18, 2023
US 8906373 37432217 July 18, 2023
US 9061005 35006312 April 11, 2025
US 8986693 37432217 April 11, 2025
US 8961974 35006312 April 11, 2025
US 8961973 35006312 April 11, 2025
US 9512216 37432217 April 11, 2025
US 9187559 35006312 April 11, 2025
US 8808700 37432217 May 16, 2026
US 11083792 38581592 April 4, 2027
US 8916153 38581592 April 4, 2027
US 8906372 38581592 April 4, 2027
US 8895009 38581592 April 4, 2027
US 8883156 38581592 April 4, 2027
US 8231876 38581592 April 4, 2027
US 9096666 38581592 April 4, 2027
US 9913902 38581592 April 4, 2027
US 9102723 38581592 April 4, 2027
US 9273132 38581592 April 4, 2027
US 9328165 38581592 April 4, 2027
US 8926975 41568843 June 8, 2027
US 8715664 37432217 July 24, 2027
US 8911964 51351473 September 13, 2027
US 8906646 39184386 September 13, 2027
US 8663945 39184386 September 13, 2027
US 9090867 51351473 September 13, 2027
US 9234032 39184386 September 13, 2027
US 9284371 39184386 September 13, 2027
US 8889136 35006312 October 9, 2027
US 9669093 40130474 June 10, 2028
US 9284370 40130474 June 10, 2028
US 11191834 51391992 November 28, 2028
US 11167030 51391992 November 28, 2028
US 9085619 51391992 November 28, 2028
US 8420081 40718465 January 13, 2030
US 8999337 40130474 February 6, 2031
US 9624295 39430215 March 31, 2031
US 8708968 45562478 January 24, 2032
US 9339610 45562478 January 24, 2032
US 9090688 46046346 April 26, 2032
US 9062106 46046346 April 26, 2032
US 9957318 48045072 April 26, 2032
US 9683033 48045072 April 26, 2032
US 9522953 52826379 April 26, 2032
US 9505834 46046346 April 26, 2032
US 9085618 52826379 March 14, 2033
US 9708400 48040434 March 14, 2033
US 9499616 52826376 March 14, 2033
US 9359434 48045072 March 14, 2033
US 9346879 48045072 March 14, 2033
US 9334319 48045072 March 14, 2033
US 9181337 52826376 March 14, 2033
US 9181572 48040434 March 14, 2033
US 9290568 51729177 March 14, 2033
US 9315574 52826379 April 21, 2033
US 9150645 48045072 May 13, 2033
US 9266949 52826379 May 13, 2033
US 9499614 50513474 March 14, 2034
US 9550826 52434932 November 14, 2034

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
See what Pro includes ↓

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
2001-06-08
Family 23144283
Nominal global expiry
2021-06-08
priority + 20 years
Latest US OB expiry
2034-11-13
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
Purple Book patents 66 unique patents listed; 66 resolved to BigQuery families (100%) Complete
Same-family international 703 documents across 41 countries via BigQuery family expansion Complete
Nominal international expiry Priority date + 20 years computed per family. Composition family nominal expiry: 2021-06-08. 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 Humira's patent landscape

When will biosimilars enter the market for Humira?
Humira's foundational composition patent already expired (Jun 8, 2021), so the cliff window is open. The cliff closes Nov 13, 2034 when the last US lifecycle patent falls. Whether biosimilars have actually entered depends on the strength of secondary patents (formulations, methods of use, manufacturing) and whether settlements were reached — the Humira precedent saw biosimilars enter ~7 years past composition expiry under licensing agreements with AbbVie.
What's the difference between "cliff opens" and "cliff closes"?
Cliff opens (Jun 8, 2021) marks Humira's foundational composition patent expiry — the earliest theoretical date for biosimilar entry. Cliff closes (Nov 13, 2034) 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 biosimilars even after the composition patent has expired.
Why is Humira in the Purple Book?
Humira is regulated via the FDA biologic license application (BLA) pathway and listed in the FDA Purple Book (biologics). Biologics are not required to list patents with the FDA — the Purple Book does not include patent listings. The patents shown here are curated by TheraRadar via Google Patents BigQuery search of the sponsor (AbbVie Inc.) and mechanism keywords, not pulled from an FDA list.
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. Humira has 21 families that resolve to 703 international documents across 41 countries. Families matter because biosimilar entry requires clearing patent barriers in each market separately — a US biosimilar launch is independent of EU or Japan launches.
How were these Humira patents identified?
Humira is a biologic, and the FDA's Purple Book does not include patent listings. TheraRadar identified these 66 patents via Google Patents BigQuery search using the sponsor (AbbVie Inc.) plus mechanism-specific keywords. This is a curated thicket, not an authoritative FDA list. We then expand each patent to its full international family using the BigQuery patent family graph. Coverage is best-effort and may not capture every patent the sponsor holds.
What does the "Multiplier" stat mean?
The multiplier shows how many international patent documents exist for every US patent in Humira's thicket — calculated as 703 international documents ÷ 66 US patents = 11×. 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.

Always free

  • 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
$99/year. Cancel anytime. Single sign-on via Google.
Patent data updated: May 26, 2026