https://www.patsnap.com/resources/blog/rd-blog/prefilled-syringe-systems-patent-landscape/ · Patsnap · data cut-off 2026-07-31 · downloaded from the live page
Patent Landscape · Drug Delivery Devices
Prefilled Syringe Systems Patents: Filing Trends and Claim Concentration
  • 39.9% of all filings sit with five assignees. 863 of the 2,164 records in scope belong to the top five, so most new entrants are filing into space someone else already occupies.
  • Filing has plateaued, not collapsed. 2021 to 2024 (the last complete year) moved from 189 to 188 filings — essentially flat, a -1% change, after peaking at 218 in 2019.
  • Device claims dominate over formulation claims. A61M (devices for body fluids) covers 69.1% of records versus 27.4% for A61K (medicinal preparations) — most of the contested ground is mechanical, not chemical.
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2,164
Published Records
40%
Top-5 Share of All Records
-1%
Filing Growth 2021→2024
US
Leading Jurisdiction

Filing growth compares 2021 (189 records) with 2024 (188) — a three-year span. 2024 is the most recent year we treat as complete: publication lags filing by roughly 18 months, so 2025 onwards are still filling in and any growth rate that ends there would understate the field. Top-5 share is the combined record count of the five largest assignees divided by all 2,164 records in scope (CR5), not by the ranked leaders only.

Published byPatsnap Research··7 min readSourced from Patsnap Eureka
Field Overview

What this landscape covers

Prefilled syringe systems sit at the intersection of container science and injection mechanics: a syringe barrel, a staked or removable needle, a plunger stopper, and the interfaces between them where a formulation can fail long before it reaches a patient. The search underlying this page combines core hardware terms — prefilled syringe, syringe barrel, staked needle — with the specific failure modes that drive most litigation and most licensing conversations in this space: silicone oil migration, break loose force, tungsten residue, glass delamination, needle shield interaction, and container closure integrity.

That combination narrows the field to 2,164 published records running from 2015 through the current data cut-off. It captures the patents that matter for anyone qualifying a fill-finish line, evaluating a biologic's primary container, or trying to design an injection device around someone else's claims on gliding force or coating chemistry.

Filing activity and technology mix, 2015 to present
  1. 1NOVARTIS AG197
  2. 2BECTON DICKINSON & CO189
  3. 3SIO2 MEDICAL PRODUCTS INC183
  4. 4WL GORE & ASSOC INC151
  5. 5AMGEN INC143
  6. 6REGENERON PHARMACEUTICALS INC133
  7. 7INJECTO95
  8. 8SIO2 MEDICAL PRODUCTS LLC89
  9. 9BECTON DICKINSON FRANCE SAS88
  10. 10WYETH LLC59
Source: Patsnap Eureka. Assignee ranking and totals. Derived from a Patsnap search on Prefilled Syringe Systems covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
The Numbers

Filing trend and technology composition

Two views of the same 2,164 records: how filing volume has moved year over year, and which IPC subclasses carry the claim weight. Because a single record can carry several classes, the composition shares add up to well over 100% — read them as density, not as a partition of the field.

Filing trend, 2017-2026

Filings ran at 192 in 2017, peaked at 218 in 2019, and held roughly flat through the last complete year — 189 in 2021 versus 188 in 2024, a -1% move. 2025 and 2026 show fewer records only because publication lags filing by roughly 18 months; those years are still filling in, not falling.

Filing trend, 2017-2026063125188250192201720182182019202020212022202320242025162026Most recent year is partial — publication lag means later filings are not yet visible.

Technology composition by IPC subclass

A61M (devices for body fluids) touches 69.1% of the 2,164 records — the mechanical side of the syringe, from barrel to needle shield, is where most claims are staked. A61K (medicinal preparations) sits far behind at 27.4%, and supporting classes — A61J containers, C23C coatings, B65B packaging, A61L sterilising — each cover single-digit-to-low-double-digit shares, marking narrower but still active claim territory.

Technology composition by IPC subclassA61M · Devices for body fluids1,49669.1%A61K · Medicinal preparations59327.4%A61P · Therapeutic activity of compou…2089.6%A61J · Containers for medicine1748.0%C07K · Peptides & proteins1748.0%C23C · Coating & surface deposition1275.9%B65B · Packaging & wrapping793.7%A61L · Sterilising & disinfecting753.5%Other76935.5%

Shares are the percentage of the 2,164 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.

Source: Patsnap Eureka. Filing trend and technology composition. Derived from a Patsnap search on Prefilled Syringe Systems covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.

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Key Patents

Most-cited records and a representative filing

Representative Filing
US11331434B22022-05-17

US11331434B2 — Botulinum toxin prefilled syringe system

MERZ PHARMA GMBH & CO. KGAA

The present invention relates a botulinum toxin prefilled syringe system with desirable injection force characteristics, in particular low gliding force and low break loose force, comprising a syringe barrel of glass containing a liquid botulinum toxin composition, a plunger stopper and a closure device such as a tip cap or a needle shield. In addition, the present invention relates to a kit comprising the botulinum toxin prefilled syringe system, and optionally instructions for use, and to the use of the botulinum toxin prefilled syringe system in therapeutic and cosmetic applications.Filed by Merz Pharma GmbH & Co. KGaA, granted 2022-05-17 — a device-plus-formulation claim structure typical of the branch pairing gliding-force control with a specific drug payload.

US11331434B2 — patent drawing 1US11331434B2 — patent drawing 2
View full record
Highest-cited records in scope
#Publication no.Patent titleCitations
1WO2012065072A2IMPROVED HIGH CONCENTRATION ANTI-TNFa ANTIBODY LIQUID FORMULATIONS156
2US20130041241A1Pecvd coating methods for capped syringes, cartridges and other articles152
3US8821865B2High concentration anti-TNFα antibody liquid formulations134
4US20080300550A1Positive displacement stopper for a pre-filled syringe117
5WO2013170052A1Saccharide protective coating for pharmaceutical package116
6US20120263731A1HIGH CONCENTRATION ANTI-TNFalpha ANTIBODY LIQUID FORMULATIONS106
7WO2014052792A1Halogenated or parylene polymer coating103
8WO2013071138A1PASSIVATION, pH PROTECTIVE OR LUBRICITY COATING FOR PHARMACEUTICAL PACKAGE, COATING PROCESS AND APPARATUS102
9US20110034882A1Stoppers Used in Pre-filled Syringes95
10WO2011080543A1Medical components having coated surfaces exhibiting low friction and/or low gas/liquid permeability89

Citation counts favour older records simply because they have had longer to accumulate citations inside this corpus — treat this table as a map of influence on the field's early direction, not a ranking of current importance.

Each row carries its publication number; clicking a row searches Eureka by that number.

Source: Patsnap Eureka. Citation counts and representative records. Derived from a Patsnap search on Prefilled Syringe Systems covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
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Analysis

What the data means for filing decisions

Three patterns worth acting on before drafting a new application or scoping a freedom-to-operate review in this space.

Concentration
39.9%
of 2,164 records held by top 5

The leader board is short and heavily weighted

The top five assignees hold 863 of the 2,164 records in scope, and the leader alone accounts for 197. Beyond the top ten — which together hold 61.3% — the field thins quickly into single-digit filers, meaning most organisations in this space hold a handful of records rather than a defensible portfolio.

Top 10 combined: 1,327 records
Momentum
-1%
filing change, 2021 to 2024

Volume has plateaued, not declined

The last three complete filing years moved from 189 to 188 — essentially flat. Recent-year YoY drops for individual assignees (several down 75-100%) reflect the 18-month publication lag more than a real pullback; treat any 2025-2026 figure as provisional.

Peak year: 2019 at 218 filings
Claim geography
69.1%
of records touch A61M

The contest is mechanical, not chemical

Devices-for-body-fluids claims (A61M) outnumber medicinal-preparation claims (A61K) by more than two to one. Coating chemistry (C23C, 5.9%) and sterilising methods (A61L, 3.5%) are present but comparatively open, suggesting the crowded ground is the barrel-plunger-needle interface itself.

A61K coverage: 27.4% of records
Filing venues
402
US receiving-office filings

US and EPO anchor the filing strategy

The United States (402) and EPO (333) lead receiving offices, with WIPO/PCT (240) used heavily for downstream national-phase entry. Australia, Canada and Israel each carry over a hundred filings, indicating a fairly standard biologics-market filing footprint rather than a region-specific play.

WIPO/PCT filings: 240
Eureka AI Agent
Looking for what nobody has claimed yet?

Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to prefilled syringe systems, with the prior art for and against each one.

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Source: Patsnap Eureka. Co-assignee relationships and derived observations. Derived from a Patsnap search on Prefilled Syringe Systems covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
Competitive Landscape

Who holds the claim space

The ranking covers 100 companies counted by patent family. It is not a top-50 or top-100 filtered list — it is the full ranking the dataset returns, and it drops off fast after the leading names.

Leader
197
records

One assignee well ahead of the field

The leading assignee holds 197 records against a fifth-place figure of 143 and a tenth-place figure of 59 — the gap between first and fifth is narrower than the gap between fifth and tenth, a sign the top tier is itself uneven.

Fifth place: 143 records
Collaboration
10
co-assignee pairs

A small, tight collaboration network

Only ten co-assignee pairings appear in the data, and the strongest pairs recur around the same handful of names — a materials-science specialist paired repeatedly with a biopharma partner. This looks like a small number of long-running supply or licensing relationships rather than a broad joint-filing culture.

Strongest pair: 26 shared records
Momentum
0% YoY
for the most stable recent filer

Recent-year activity is thin across the board

Latest-year counts by assignee are low in absolute terms — single digits for every name tracked — and most show sharp YoY drops. Given the 18-month publication lag, this reads as incomplete data filling in rather than a genuine slowdown in any one company's programme.

Data cut-off: 2026-07-31
🔍
Under-claimed branches worth a closer look
Sub-areas where filing density is visibly lower than the core barrel-and-plunger claims
low-tungsten staked-needle manufacturingsilicone-free lubricant coatingsdelamination-resistant glass surface treatmentsneedle-shield removal force controlsterilising methods for pre-assembled cartridges
Rank all filers by momentum →
Recent-year filing momentum by assignee
AssigneeRecent yearYoY
Regeneron Pharmaceuticals Inc70%
Becton Dickinson & Co3-79%
Amgen Inc1-75%
Becton Dickinson France SAS1-86%
SiO2 Medical Products Inc0-100%
Novartis AG0-100%
W.L. Gore & Associates Inc0—
Injecto0-100%
Source: Patsnap Eureka. Assignee-level momentum. Derived from a Patsnap search on Prefilled Syringe Systems covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
Next Steps

Where to take this next

The landscape points to where claim space is dense and where it is thin. Turning either into a filing or freedom-to-operate decision needs a closer read of the actual claim language.

Run a freedom-to-operate check on break loose force claims

The most-cited records in this set include device patents specifically directed at gliding and break loose force — exactly the mechanical parameters a new device program is likely to specify.

Explore claim charts in Eureka →

Map the under-claimed coating and sterilising branches

C23C coating claims and A61L sterilising claims each cover under 6% of records — worth a deeper pull before assuming the space is occupied.

Pull the full IPC breakdown in Eureka →

Track the leading assignees' recent filings directly

Aggregate YoY figures understate 2025-2026 activity because of publication lag; a per-assignee alert catches new filings as they publish.

Set up assignee tracking in Eureka →
Source: Patsnap Eureka. Forward-looking reading of the same dataset. Derived from a Patsnap search on Prefilled Syringe Systems covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
FAQ

Common questions on prefilled syringe patents

Answers are grounded in the same dataset. Derived from a Patsnap search on Prefilled Syringe Systems covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP

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Disclaimer. This page is generated from Patsnap Eureka data drawn from a limited snapshot of global patent and scientific-literature records, and is provided for general information and reference only.

Patent data carries inherent limitations: recent filings (typically the most recent 18–24 months) are under-counted due to standard publication lag; counts may be reported at either a patent-family or a patent-record basis and are not always directly comparable; classification, applicant-name, and citation data may contain errors, duplicates, or omissions; and the underlying search query defines and constrains the scope shown. As a result, the analysis may be incomplete or inaccurate and may not reflect the full technology landscape.

Nothing on this page constitutes an exhaustive prior-art, novelty, freedom-to-operate, or validity search, nor does it constitute legal, financial, investment, or professional advice, and it should not be relied upon as such. Any patent, commercial, or strategic decision should be verified independently and reviewed with qualified patent, legal, and domain professionals. Patsnap makes no warranties, express or implied, as to the accuracy, completeness, or fitness for any particular purpose of the information presented.

Machine translation. Assignee and organisation names originally recorded in Chinese, Japanese or Korean have been rendered into English by an AI translation step so that the tables stay readable. These renderings are best-effort and may not match a company's registered English name; the original name is what the underlying patent record carries, and it is what any Eureka query launched from this page uses.

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