https://www.patsnap.com/resources/blog/rd-blog/prefilled-syringe-components-and-silicone-patent-landscape/ · Patsnap · data cut-off 2026-07-31 · downloaded from the live page
Patent Landscape · Medical Equipment
Prefilled Syringe Components and Silicone Patents
  • 72.5% concentration. The top five assignees hold 95 of 131 records in scope, so the field reads as a small group of holders rather than an open race.
  • Filing has cooled from its 2017 peak of 29. Filings fell 27% from 11 in 2021 to 8 in 2024, the last year the trend can be treated as complete.
  • A61M dominates the class mix. 96 of 131 records (73.3%) sit in devices for body fluids, while force-and-pressure measurement (G01L) and lab apparatus (B01L) each cover under 7%.
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131
Published Records
73%
Top-5 Share of All Records
-27%
Filing Growth 2021→2024
US
Leading Jurisdiction

Filing growth compares 2021 (11 records) with 2024 (8) — 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 131 records in scope (CR5), not by the ranked leaders only.

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

What this landscape covers

This landscape tracks 131 published records at the intersection of prefilled syringe design and siliconization, drawn from a search targeting break loose force, silicone oil migration, protein aggregation, tungsten residue, container closure integrity and baked-on siliconization. The scope spans filings from 2015 through the 2026 data cut-off, capturing both device-side claims (syringe barrels, plunger stoppers, closure systems) and formulation-side claims tied to biologic drug stability.

Coverage concentrates in the United States, Europe and Israel as receiving offices, with a meaningful share routed through the WIPO PCT system, consistent with a field where device makers and biologic drug sponsors file for parallel protection across major pharmaceutical markets.

Filing activity and technology composition, 2015-2026
  1. 1MERZ PHARMA GMBH & CO KGAA30
  2. 2TEVA PHARMACEUTICALS INTERNATIONAL GMBH28
  3. 3NEVAKAR INJECTABLES INC13
  4. 4F HOFFMANN LA ROCHE & CO AG13
  5. 5GENNOVA BIOPHARMACEUTICALS LTD11
  6. 6WYETH LLC9
  7. 7CHUGAI PHARMA CO LTD7
  8. 8BECTON DICKINSON FRANCE SAS5
  9. 9F HOFFMANN LA ROCHE INC5
  10. 10AMGEN INC5
Source: Patsnap Eureka. Assignee ranking and totals. Derived from a Patsnap search on Prefilled Syringe Components and Silicone 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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The Data

Filing trend and technology composition

Two views of the same 131-record dataset: filing activity by year, and the IPC subclasses those records fall under.

Filings rose to a 2017 peak, then eased

Filings peaked at 29 in 2017 and have since declined; the most recent complete comparison shows a 27% drop from 11 filings in 2021 to 8 in 2024. Because publication typically lags filing by roughly 18 months, 2025 and 2026 figures are still filling in and should not be read as a further slowdown.

Filings rose to a 2017 peak, then eased081523302920172018201920202021202220232024202502026Most recent year is partial — publication lag means later filings are not yet visible.

Device claims outweigh formulation and measurement claims

A61M (devices for body fluids) appears in 73.3% of records and A61K (medicinal preparations) in 48.1%, confirming this is primarily a device-and-formulation field. Peptide and protein claims (C07K, 13.7%), force measurement (G01L, 6.9%) and lab apparatus (B01L, 3.8%) are present but comparatively thin, which is where narrower claim opportunities tend to sit.

Device claims outweigh formulation and measurement claimsA61M · Devices for body fluids9673.3%A61K · Medicinal preparations6348.1%C07K · Peptides & proteins1813.7%A61P · Therapeutic activity of compou…118.4%C07D · Heterocyclic compounds96.9%G01L · Force & pressure measurement96.9%A61B · Diagnosis & surgery64.6%B01L · Lab apparatus53.8%Other2015.3%

Shares are the percentage of the 131 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 Components and Silicone 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 in this dataset

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, published 2022-05-17. Anchors a cluster of claims around gliding force and break loose force control for glass barrel systems.

US11331434B2 — patent drawing 1US11331434B2 — patent drawing 2
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Highest-citation records
#Publication no.Patent titleCitations
1US20140249484A1Plasma or CVD pre-treatment for lubricated pharmaceutical package, coating process and apparatus64
2US20190151544A1Syringe adapter and guide for filling an on-body injector34
3US9662450B2Plasma or CVD pre-treatment for lubricated pharmaceutical package, coating process and apparatus30
4WO2017220553A1Botulinum toxin prefilled syringe system26
5US20190201630A1Botulinum toxin prefilled syringe system23
6WO2018215580A1Method for sterilizing prefilled plastic syringes containing a VEGF antagonist15
7US20200315955A1Succinylcholine prefilled syringe, compositions and methods9
8WO2019177725A1Prefilled syringe, compositions and methods6
9US20210172815A1Validation apparatus for validating a force testing machine, method of validating a force testing machine and…6
10CN101780033A一种预充式重组人干扰素注射剂6

Citation counts reflect influence within the searched corpus and favour older filings; treat them as a signal of prior-art density, not of current commercial relevance.

Patent titles are shown in the language they were filed in, not translated, so that each record stays verifiable against the original filing — a translated title will not match in Eureka or in any national register. 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 Components and Silicone 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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Insights

What the numbers mean for filing strategy

Reading concentration, class mix and citation data together points to where claim space is occupied and where it is thinner.

Concentration
72.5%
of 131 records held by top 5

A small group holds most of the claim space

With the top five assignees accounting for 72.5% of all 131 records and the top ten reaching 96.2%, new entrants are filing into a field where dominant positions on core syringe siliconization and break loose force claims are already staked out by a handful of holders.

Top 10 combined: 126 of 131 records
Filing momentum
-27%
2021 to 2024 filings

Activity has cooled from its 2017 high

Filings peaked at 29 in 2017 and dropped 27% between 2021 (11) and 2024 (8), the last year with a complete count. That pattern is consistent with a maturing device category rather than an emerging one, though publication lag means the very latest years are not yet a reliable read.

Peak year: 2017 at 29 filings
Class distribution
73.3%
of records in A61M

Device claims crowd out measurement and lab claims

A61M and A61K together cover the great majority of records, while G01L (force and pressure measurement) and B01L (lab apparatus) sit under 7% each. Dense device claiming alongside thin measurement-method claiming suggests occupied territory on hardware, with more room on how break loose force and migration are actually measured and validated.

G01L and B01L each under 7% of records
Citation signal
64 citations
on the top-cited record

Coating process patents anchor the field

The most-cited record concerns plasma or CVD pre-treatment for lubricated pharmaceutical packaging, cited 64 times, with a related family member cited 30 times. Botulinum toxin prefilled syringe system filings also draw heavy citation, indicating these are the reference points examiners and competitors are working around.

Citation counts favour older filings
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 components and silicone, with the prior art for and against each one.

Find the white space →
Source: Patsnap Eureka. Co-assignee relationships and derived observations. Derived from a Patsnap search on Prefilled Syringe Components and Silicone 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
Players

Who holds the claim space

The assignee ranking returned by the data endpoint covers 21 companies in total, counted in records, not the full universe of filers in this field.

Leader
30 records
leading assignee

A single holder sets the pace

The top-ranked assignee holds 30 of the 131 records in scope, well ahead of fifth place at 11, underscoring how much of the core syringe and closure claim space traces back to one filer's continuation strategy.

Gap to fifth place: 30 vs 11 records
Mid-tier
11 to 5 records
fifth to tenth place

A thin middle tier before the long tail

Positions five through ten span 11 records down to 5, a narrower band than the gap between first and fifth place. Recent-year momentum for several named assignees in this band shows zero filings in the latest year, consistent with the broader post-2021 slowdown.

Tenth place: 5 records
Collaboration
3 pairs
co-assignee pairs identified

Co-filing is rare and concentrated

Only three co-assignee pairs appear in the dataset, and the strongest of them recurs across seven records, linking a major biologic drug maker with a specialist formulation partner. Outside that pairing, co-assignment is minimal, meaning most protection here is built as single-owner portfolios rather than joint filings.

Strongest pair: 7 shared records
🔍
Under-claimed sub-areas worth checking before filing
These branches carry fewer records relative to the core device and formulation classes, based on the IPC composition above.
Break loose force measurement methodsSilicone-free or baked-on siliconization coating processesTungsten-residue detection apparatusContainer closure integrity test protocolsLab-scale siliconization apparatus (B01L)
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Recent-year filing momentum by assignee
AssigneeRecent yearYoY
Merz Pharma GmbH & Co. KGaA0-100%
Teva Pharmaceuticals International GmbH0
F. Hoffmann-La Roche AG0
Nevakar Injectables Inc0
Gennova Biopharmaceuticals Ltd0
Wyeth LLC0
Chugai Pharma Co Ltd0
F. Hoffmann-La Roche Inc0
Source: Patsnap Eureka. Assignee-level momentum. Derived from a Patsnap search on Prefilled Syringe Components and Silicone 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
What's Next

Where to take this next

This landscape shows where claims already sit dense and where they are thinner. Turning that into a filing or freedom-to-operate position means going record by record.

Map claims against your own device design

Run your syringe barrel, coating or closure design against the highest-citation records identified here to see which claim elements you already clear and which need a design-around.

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Track the mid-tier assignees for shifts

The fifth-through-tenth band shows recent-year momentum flattening for several holders; a fresh pull closer to filing will show whether any have resumed activity outside this dataset's window.

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Test the under-claimed branches

Measurement-method and lab-apparatus classes carry far fewer records than core device classes. Drafting a first claim there means checking the thin prior art directly rather than assuming it is open.

Search white space in Patsnap Eureka
Source: Patsnap Eureka. Forward-looking reading of the same dataset. Derived from a Patsnap search on Prefilled Syringe Components and Silicone 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 this landscape

Answers are grounded in the same dataset. Derived from a Patsnap search on Prefilled Syringe Components and Silicone 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.