Patent landscape
Prolia (denosumab)
Amgen Inc. · Targets: RANKL · First FDA approval 2010-06-01
Purple Book + BigQuery
Patent data as of 2026-05-15
Curated patents
57
33 families
Global footprint
1,053
across 44 countries
Multiplier
18×
intl docs / curated patents
Cliff closes
Sep 1, 2040
Last US lifecycle patent falls
Cliff opens
Jun 26, 2021
Foundational composition expiry
Cliff window: opened Jun 26, 2021 (foundational composition expired) and closes Sep 1, 2040 (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 57 US patents.
BigQuery family expansion shows the same inventions filed as 1,053 documents across 44 countries in 33 patent families — 18× the US count.
Patent portfolio
Family-by-family interpretation: which family anchors composition, which add lifecycle, when each expires.
TheraRadar's curated thicket identifies 57 patents mapped to 33 families, supported by a broad global footprint of 1053 international documents across 44 countries. The international-to-US document multiplier is notable at over 18x, reflecting a highly globalized filing strategy for these curated, non-FDA-listed biologic patents.
Pro Composition anchor, lifecycle layers, outlook — Remaining 4 sections of the estate analysis
See what Pro includes ↓ Orange Book patent stack
57 unique patents listed against this drug. All mapped to BigQuery patent families.
| Patent | Family | Claim type | Use code | US expiry |
|---|---|---|---|---|
| US 8058418 | 23162250 | — | — | November 30, 2023 |
| US 7364736 | 23162250 | — | — | February 19, 2025 |
| US 7427659 | 34549339 | — | — | March 15, 2025 |
| US 8460896 | 37945030 | — | — | December 6, 2026 |
| US 8680248 | 37945030 | — | — | December 6, 2026 |
| US 8247210 | 37945030 | — | — | December 6, 2026 |
| US 8217153 | 38256969 | — | — | January 5, 2027 |
| US 7928205 | 36129791 | — | — | February 12, 2027 |
| US 7888101 | 37945030 | — | — | April 6, 2027 |
| US 7662930 | 38218413 | — | — | April 24, 2027 |
| US 9359435 | 38266667 | — | — | May 22, 2027 |
| US 8053236 | 40002619 | — | — | January 19, 2030 |
| US 9228168 | 40002619 | — | — | January 19, 2030 |
| US 9320816 | 39722676 | — | — | November 14, 2030 |
| US 9012178 | 44511570 | — | — | August 5, 2031 |
| US 9388447 | 46000408 | — | — | April 20, 2032 |
| US 9133493 | 46000408 | — | — | April 20, 2032 |
| US 11685772 | 46579326 | — | — | June 29, 2032 |
| US 11634476 | 46579326 | — | — | June 29, 2032 |
| US 11292829 | 46579326 | — | — | June 29, 2032 |
| US 9371554 | 47559662 | — | — | December 14, 2032 |
| US 11293930 | 49549113 | — | — | March 26, 2033 |
| US 11486883 | 49549113 | — | — | March 26, 2033 |
| US 9328134 | 50238475 | — | — | February 20, 2034 |
| US 11319568 | 50397323 | — | — | March 10, 2034 |
| US 12084686 | 66542532 | — | — | March 10, 2034 |
| US 11459595 | 50397323 | — | — | March 10, 2034 |
| US 11952605 | 50397323 | — | — | March 10, 2034 |
| US 11492372 | 50424772 | — | — | March 11, 2034 |
| US 10894972 | 51985530 | — | — | May 29, 2034 |
| US 11434514 | 51985530 | — | — | May 29, 2034 |
| US 9481901 | 51985530 | — | — | May 29, 2034 |
| US 11946085 | 51985530 | — | — | May 29, 2034 |
| US 10421987 | 51985530 | — | — | May 29, 2034 |
| US 9803166 | 46964067 | — | — | September 29, 2034 |
| US 11299760 | 51905413 | — | — | October 30, 2034 |
| US 11254963 | 52273554 | — | — | December 9, 2034 |
| US 10513723 | 52273554 | — | — | December 9, 2034 |
| US 10227627 | 53757626 | — | — | December 11, 2034 |
| US 10106829 | 59018383 | — | — | December 11, 2034 |
| US 10655156 | 53757626 | — | — | December 11, 2034 |
| US 10907186 | 53757626 | — | — | December 11, 2034 |
| US 11130980 | 51905413 | — | — | April 5, 2035 |
| US 11077404 | 53284536 | — | — | May 13, 2035 |
| US 11427848 | 53433304 | — | — | June 4, 2035 |
| US 11384378 | 53433304 | — | — | June 4, 2035 |
| US 10583397 | 53284536 | — | — | July 28, 2035 |
| US 11786866 | 53284536 | — | — | October 21, 2035 |
| US 11192919 | 50424772 | — | — | November 13, 2035 |
| US 10822630 | 55024253 | — | — | December 1, 2035 |
| US 10167492 | 55024253 | — | — | December 1, 2035 |
| US 11275090 | 54754830 | — | — | July 2, 2037 |
| US 11098079 | 56802689 | — | — | July 21, 2037 |
| US 9881367 | 61005547 | — | — | August 9, 2037 |
| US 12025618 | 63350601 | — | — | August 26, 2039 |
| US 11744950 | 65529831 | — | — | November 21, 2039 |
| US 12059555 | 72521731 | — | — | September 2, 2040 |
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
2001-06-26
Family 23162250
Nominal global expiry
2021-06-26
priority + 20 years
Latest US OB expiry
2040-09-01
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 | 57 unique patents listed; 57 resolved to BigQuery families (100%) | Complete |
| ✓ | Same-family international | 1,053 documents across 44 countries via BigQuery family expansion | Complete |
| ✓ | Nominal international expiry | Priority date + 20 years computed per family. Composition family nominal expiry: 2021-06-26. | 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 Prolia's patent landscape
- When will biosimilars enter the market for Prolia?
- Prolia's foundational composition patent already expired (Jun 26, 2021), so the cliff window is open. The cliff closes Sep 1, 2040 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 26, 2021) marks Prolia's foundational composition patent expiry — the earliest theoretical date for biosimilar entry. Cliff closes (Sep 1, 2040) 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 Prolia in the Purple Book?
- Prolia 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 (Amgen 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. Prolia has 33 families that resolve to 1,053 international documents across 44 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 Prolia patents identified?
- Prolia is a biologic, and the FDA's Purple Book does not include patent listings. TheraRadar identified these 57 patents via Google Patents BigQuery search using the sponsor (Amgen 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 Prolia's thicket — calculated as 1,053 international documents ÷ 57 US patents = 18×. 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