Patent landscape
Padcev (enfortumab vedotin-ejfv)
Astellas Pharma US, Inc. · Targets: Nectin-4, Tubulin · First FDA approval 2019-12-18
Purple Book + BigQuery
Patent data as of 2026-05-15
Curated patents
55
55 families
Global footprint
1,728
across 47 countries
Multiplier
31×
intl docs / curated patents
Cliff closes
Oct 31, 2042
Last US lifecycle patent falls
Cliff opens
Feb 20, 2023
Foundational composition expiry
Cliff window: opened Feb 20, 2023 (foundational composition expired) and closes Oct 31, 2042 (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 55 US patents.
BigQuery family expansion shows the same inventions filed as 1,728 documents across 47 countries in 55 patent families — 31× the US count.
Patent portfolio
Family-by-family interpretation: which family anchors composition, which add lifecycle, when each expires.
The patent estate for Padcev (enfortumab vedotin-ejfv) comprises 55 curated patents matched to 55 distinct families, yielding a substantial global footprint of 1,728 international documents across 47 countries. With a multiplier of over 31x (international documents to curated US patents), this thicket reflects a highly internationalized 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
55 unique patents listed against this drug. All mapped to BigQuery patent families.
| Patent | Family | Claim type | Use code | US expiry |
|---|---|---|---|---|
| US 8535678 | 32908685 | — | — | February 20, 2023 |
| US 8663642 | 46328663 | — | — | February 20, 2023 |
| US 10808039 | 34916511 | — | — | November 6, 2023 |
| US 7750116 | 42307008 | — | — | February 18, 2026 |
| US 8263083 | 40549535 | — | — | October 12, 2027 |
| US 9211319 | 42316833 | — | — | January 9, 2029 |
| US 8309093 | 42781369 | — | — | March 6, 2029 |
| US 8758758 | 50944006 | — | — | January 8, 2030 |
| US 9308278 | 44355840 | — | — | February 8, 2030 |
| US 8637642 | 45871300 | — | — | September 29, 2030 |
| US 12496353 | 45975893 | — | — | October 22, 2030 |
| US 9958455 | 47996407 | — | — | September 29, 2031 |
| US 9138486 | 47178799 | — | — | November 17, 2031 |
| US 11147852 | 47678913 | — | — | December 23, 2031 |
| US 11634503 | 50150421 | — | — | August 23, 2032 |
| US 9504669 | 49958508 | — | — | November 5, 2032 |
| US 9433687 | 49585464 | — | — | November 7, 2032 |
| US 9828428 | 49955428 | — | — | November 7, 2032 |
| US 9708404 | 50979291 | — | — | December 21, 2032 |
| US 9453046 | 51537504 | — | — | March 13, 2033 |
| US 9610361 | 51659070 | — | — | March 13, 2033 |
| US 11633500 | 51302793 | — | — | August 1, 2033 |
| US 10421815 | 51585144 | — | — | August 2, 2033 |
| US 9381205 | 51869058 | — | — | November 4, 2033 |
| US 10086085 | 52629620 | — | — | January 27, 2034 |
| US 12257281 | 53800705 | — | — | February 17, 2034 |
| US 11602525 | 53398151 | — | — | April 25, 2034 |
| US 9777070 | 54249561 | — | — | April 30, 2034 |
| US 10967068 | 54266589 | — | — | August 28, 2034 |
| US 10751422 | 56879165 | — | — | March 9, 2035 |
| US 11541127 | 52875694 | — | — | April 15, 2035 |
| US 11351269 | 57609137 | — | — | June 30, 2035 |
| US 11980669 | 56855760 | — | — | August 12, 2035 |
| US 10689458 | 57485830 | — | — | November 30, 2035 |
| US 11661438 | 57755408 | — | — | December 21, 2035 |
| US 10723727 | 57963390 | — | — | February 1, 2036 |
| US 11325980 | 59852409 | — | — | March 15, 2036 |
| US 11027021 | 59852023 | — | — | March 15, 2036 |
| US 11299543 | 59067913 | — | — | June 2, 2036 |
| US 11110179 | 60477980 | — | — | June 3, 2036 |
| US 11191771 | 60578941 | — | — | June 9, 2036 |
| US 11712480 | 59677272 | — | — | August 3, 2036 |
| US 11833216 | 60117722 | — | — | October 17, 2036 |
| US 11541128 | 63044836 | — | — | December 14, 2036 |
| US 11993625 | 61168135 | — | — | January 24, 2037 |
| US 11292837 | 64566092 | — | — | June 5, 2037 |
| US 11364303 | 65896231 | — | — | September 29, 2037 |
| US 11795229 | 64477266 | — | — | October 11, 2037 |
| US 11613581 | 64109968 | — | — | October 27, 2037 |
| US 12371507 | 70612233 | — | — | November 9, 2038 |
| US 12257340 | 70974767 | — | — | December 3, 2038 |
| US 11617798 | 69740807 | — | — | February 5, 2039 |
| US 12421312 | 72964849 | — | — | October 4, 2039 |
| US 12268751 | 76222033 | — | — | December 5, 2039 |
| US 12390536 | 90930522 | — | — | October 31, 2042 |
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
2003-02-20
Family 32908685
Nominal global expiry
2023-02-20
priority + 20 years
Latest US OB expiry
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 | |
|---|---|---|---|
| ⚠ | Curated patent seeds (not FDA-listed) | 55 patents identified via Google Patents BigQuery search of Merck/MSD-assigned anti-PD-1 patents. Biologics aren't FDA-listed in Orange Book, and Purple Book doesn't mandate patent disclosure — so this thicket is curated, not authoritative. | Curated |
| Curated from Google Patents (broadened search). Not FDA-authoritative. | |||
| ✓ | Same-family international | 1,728 documents across 47 countries via BigQuery family expansion | Complete |
| ✓ | Nominal international expiry | Priority date + 20 years computed per family. Composition family nominal expiry: 2023-02-20. | 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 Padcev's patent landscape
- When will biosimilars enter the market for Padcev?
- Padcev's foundational composition patent already expired (Feb 20, 2023), so the cliff window is open. The cliff closes Oct 31, 2042 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 (Feb 20, 2023) marks Padcev's foundational composition patent expiry — the earliest theoretical date for biosimilar entry. Cliff closes (Oct 31, 2042) 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 Padcev in the Purple Book?
- Padcev 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 (Astellas Pharma US, 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. Padcev has 55 families that resolve to 1,728 international documents across 47 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 Padcev patents identified?
- Padcev is a biologic, and the FDA's Purple Book does not include patent listings. TheraRadar identified these 55 patents via Google Patents BigQuery search using the sponsor (Astellas Pharma US, 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 Padcev's thicket — calculated as 1,728 international documents ÷ 55 US patents = 31×. 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