https://www.patsnap.com/resources/blog/rd-blog/pharmaceutical-lyophilization-cycle-design-patent-landscape/ · Patsnap · data cut-off 2026-07-31 · downloaded from the live page
Patent Landscape · Pharmaceutical Manufacturing
Pharmaceutical Lyophilization Cycle Design Patents
  • Filings peaked in 2019 at 313 and fell -58% from 233 in 2021 to 98 in 2024, the last year the dataset treats as complete.
  • The ranked field is not a monopoly the leading assignee holds 522 records but the top 5 combined are only 23.0% of all 5,844 records in scope.
  • A61K dominates at 83.1% of records while dedicated drying-equipment class F26B appears in just 5.2%, a gap worth checking before filing.
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5,844
Published Records
23%
Top-5 Share of All Records
-58%
Filing Growth 2021→2024
US
Leading Jurisdiction

Filing growth compares 2021 (233 records) with 2024 (98) — 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 5,844 records in scope (CR5), not by the ranked leaders only.

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

What this patent set covers

Records in scope combine language around lyophilization cycle and freeze drying cycle design with process-control terms — shelf temperature, chamber pressure, primary drying time, sublimation rate, product temperature probe and cycle robustness. That pairing narrows the set to filings that claim or describe how a freeze-drying cycle is actually designed and controlled, rather than every patent that merely mentions a lyophilized formulation. The result spans 5,844 published records filed or published between 2015 and mid-2026.

Because publication trails filing by roughly 18 months, the most recent one to two years in any trend chart will always look thinner than the underlying filing activity actually was. Read the 2024 figure, not 2025 or 2026, as the last reliable annual data point.

Filing activity and technology composition, 2015-2026
  1. 1AMGEN INC522
  2. 2TAKEDA PHARMA CO LTD287
  3. 3MILLENNIUM PHARMACEUTICALS INC251
  4. 4NOVARTIS AG160
  5. 5CELGENE CORP122
  6. 6WYETH LLC106
  7. 7WYETH HOLDINGS CORP101
  8. 8IMMUNOGEN INC100
  9. 9CEPHALON INC98
  10. 10PROGENICS PHARMACEUTICALS INC97
Source: Patsnap Eureka. Assignee ranking and totals. Derived from a Patsnap search on Pharmaceutical Lyophilization Cycle Design 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 Numbers

Filing trend and technology composition

Two views of the same 5,844-record set: how filing activity has moved year over year, and which IPC subclasses carry the claim language.

Filings rose to a 2019 peak, then declined

Annual filings climbed from 294 in 2017 to a peak of 313 in 2019, then fell to 233 by 2021 and 98 by 2024 — a -58% drop over that three-year span. 2025 and 2026 figures are still incomplete due to publication lag and should not be read as a continued collapse.

Filings rose to a 2019 peak, then declined010020030040029420172018313201920202021202220232024202592026Most recent year is partial — publication lag means later filings are not yet visible.

A61K and C07K anchor the field

Medicinal preparations (A61K) appear in 83.1% of records and peptide/protein chemistry (C07K) in 29.7%, reflecting how much of this cycle-design activity is tied to biologic formulations. Dedicated drying engineering (F26B, 5.2%) and sterilising/disinfecting (A61L, 3.8%) are present but comparatively thin, since records can carry multiple classes these shares add to more than 100%.

A61K and C07K anchor the fieldA61K · Medicinal preparations4,85983.1%C07K · Peptides & proteins1,73329.7%A61P · Therapeutic activity of compou…1,68328.8%C12N · Microorganisms & genetic engin…5479.4%F26B · Drying3025.2%C07D · Heterocyclic compounds2464.2%A61L · Sterilising & disinfecting2223.8%G01N · Material analysis & testing2123.6%Other1,15119.7%

Shares are the percentage of the 5,844 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 Pharmaceutical Lyophilization Cycle Design 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

A representative filing and the most-cited prior art

Representative Filing
US20090324586A12009-12-31

Lyophilization Cycle Robustness Strategy

WYETH LLC

The present invention provides methods for assessing and optimizing lyophilization cycle robustness. In particular, the present invention provides rapid assessment of cycle robustness with respect to a variety of lyophilization process deviations by varying a relatively small number of parameters.Filed by Wyeth LLC, published 2009-12-31 as US20090324586A1.

US20090324586A1 — patent drawing 1US20090324586A1 — patent drawing 2
View full filing
Most-cited records in this set
#Publication no.Patent titleCitations
1US6267958B1Protein formulation3,205
2US6503259B2Expandable anastomotic device2,305
3US6333029B1Porous tissue scaffoldings for the repair of regeneration of tissue1,994
4US6355699B1Process for manufacturing biomedical foams1,954
5US6306424B1Foam composite for the repair or regeneration of tissue1,863
6WO1997004801A1Stabile isotonic lyophilized protein formulation1,403
7EP1234587A1Biocompatible foam composite953
8US5997895ADural/meningeal repair product using collagen matrix622
9US6685940B2Protein formulation621
10US6534084B1Porous tissue scaffoldings for the repair or regeneration of tissue572

Citation counts reflect influence within the searched corpus and favour older filings; they are not a measure of current commercial relevance.

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 Pharmaceutical Lyophilization Cycle Design 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 data means for strategy

Three read-throughs from the filing trend, the concentration figures and the technology composition.

Filing Momentum
-58%
2021 to 2024 filings

The decline is real but the field is not empty

Annual filings dropped from 233 in 2021 to 98 in 2024. That is a genuine slowdown after the 2019 peak of 313, not an artifact of publication lag since 2024 is treated as a complete year. New entrants should weigh whether this reflects claim space filling up or interest moving to adjacent process areas.

Based on complete-year filings through 2024.
Concentration
23.0%
top 5 share of 5,844 records

A leader, but a long tail behind it

The leading assignee holds 522 records, yet the top 5 combined account for only 23.0% of all 5,844 records in scope, and the top 10 combined for 31.6%. That leaves the majority of filings distributed across a long tail of single- and few-filing entrants — freedom-to-operate work cannot rely on checking only the largest holders.

Ranking covers 100 companies, the whole set the data endpoint returns.
Technology Mix
83.1%
records tagged A61K

Formulation claims dominate, drying engineering is thinner

Medicinal preparations (A61K) sit in the large majority of records, and peptide/protein chemistry (C07K) in nearly a third, showing this field is driven mostly by biologic formulation work rather than equipment design. Drying (F26B) at 5.2% and material analysis (G01N) at 3.6% suggest process-instrumentation claims are comparatively less contested.

Shares are of all 5,844 records; a record can carry multiple IPC classes.
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 pharmaceutical lyophilization cycle design, 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 Pharmaceutical Lyophilization Cycle Design 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
Who Is Filing

Assignee landscape and where the gaps sit

The ranked assignee list covers 100 companies drawn from the full record set. Ownership is led but not locked up: the top 5 hold 23.0% of all 5,844 records and the top 10 hold 31.6%, leaving most filings spread thin.

Leader
522
records

One assignee well ahead of the field

The leading assignee's 522 records sit well clear of fifth place at 122 and tenth place at 97, a gap that signals a sustained, multi-generation filing program rather than a single burst of activity around one product.

Counted in records across the ranking.
Recent Momentum
-33% YoY
leading assignee, latest year

Even active filers are pulling back

The most active recent filer logged 4 filings in the latest year, down 33% year over year, while several other historically major assignees show 0 filings in the latest year. This is consistent with the broader -58% decline from 2021 to 2024 rather than a sign any single company has stopped competing.

Latest-year counts are subject to publication lag.
Collaboration
10
co-assignee pairs identified

Cross-filing is limited and clustered

Only 10 co-assignee pairs appear in the dataset, and the strongest pairing links two related pharmaceutical entities that filed jointly 24 times. Collaboration here looks like corporate affiliation rather than open cross-licensing between competitors.

Pair counts reflect joint-assignee filings only.
🔍
Under-claimed sub-areas worth checking before filing
Based on the thinner IPC classes relative to the dominant formulation and biologic classes.
Drying-chamber instrumentationSublimation-rate sensing methodsAutomated cycle-robustness testingNon-biologic small-molecule cycle claimsProduct temperature probe placement
Rank all filers by momentum →
Filing momentum by leading assignee
AssigneeRecent yearYoY
Takeda Pharmaceutical Company Limited4-33%
Amgen Inc.1-91%
Millennium Pharmaceuticals, Inc.0-100%
Novartis AG0-100%
Celgene Corporation0
Merck Sharp & Dohme0
Bristol-Myers Squibb Company0
Wyeth LLC0
Source: Patsnap Eureka. Assignee-level momentum. Derived from a Patsnap search on Pharmaceutical Lyophilization Cycle Design 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 analysis

The dataset points to specific next steps depending on whether the goal is freedom-to-operate, portfolio strategy or R&D prioritisation.

Check freedom-to-operate against the long tail

Because the top 10 hold only 31.6% of records, a clearance search focused solely on the largest assignees will miss most of the field. Run a targeted search across the full ranked set before committing to a cycle-design approach.

Explore assignees in Eureka

Probe the thinner IPC classes for open claims

F26B, A61L and G01N sit well below A61K and C07K in record share, which is where narrower, more defensible claims may still be available around drying equipment and process instrumentation.

Run a white-space search in Eureka

Track momentum, not just headcount

Several previously major filers show 0 filings in the latest year while the overall field declined -58% from 2021 to 2024. Monitoring which assignees are still actively filing matters more than static rankings for competitive tracking.

Set up monitoring in Eureka
Source: Patsnap Eureka. Forward-looking reading of the same dataset. Derived from a Patsnap search on Pharmaceutical Lyophilization Cycle Design 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 Pharmaceutical Lyophilization Cycle Design 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.