Lyoprotectant Patents: Leaders, Trends & White Space 2026
- 25.8% concentration at the top. The five leading assignees together hold 1,209 of the 4,685 records in scope, but the remaining 74.2% is spread across a long tail of single- and few-filing entrants.
- Filings cooled from a 2020 peak. Annual filings hit 299 in 2020 and fell to 142 by 2024, a 38% decline from the 2021 figure of 229 — though 2025-2026 counts are still filling in due to publication lag.
- A61K dominates, but peptide claims are close behind. 85.3% of records carry an A61K medicinal-preparations class, while 28.6% also carry C07K peptide and protein claims, showing formulation and biologic-stability claims are tightly overlapped.
Filing growth compares 2021 (229 records) with 2024 (142) — 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 4,685 records in scope (CR5), not by the ranked leaders only.
What this landscape covers
This dataset tracks 4,685 patent records published between 2015 and mid-2026 that combine lyoprotectant or cryoprotectant excipient language with specific formulation parameters — sucrose concentration, trehalose stabilizer systems, mannitol crystallization behaviour, glass transition temperature, residual moisture and cake collapse. That combination narrows the field to filings that actually claim or describe freeze-drying formulation mechanics, rather than any patent that merely mentions lyophilization in passing. The scope spans biologics stabilization, vaccine formulation and small-molecule freeze-dried products, and the assignee base is dominated by large-molecule and vaccine developers.
Patent families are the fairer unit for judging real filing activity here, since a single formulation programme can generate several continuation or multi-jurisdiction documents. Readers should treat the most recent one to two years of filing counts as understated, because publication typically lags filing by around 18 months.
Filing trends and technology composition
The filing curve and IPC composition together show where lyoprotectant claim activity is concentrated and how the pace of new filing has moved since the field's most active years.
Filing activity peaked in 2020
Annual filings rose from 227 in 2017 to a peak of 299 in 2020, then eased to 229 in 2021 and 142 in 2024 — a 38% decline over that three-year span. Counts for 2025 and 2026 are still incomplete because of the roughly 18-month gap between filing and publication, so the apparent recent drop should not be read as the field going quiet.
A61K and C07K carry the bulk of claim activity
A61K medicinal-preparations claims appear in 85.3% of the 4,685 records, reflecting the formulation-heavy nature of this space. C07K peptide and protein claims (28.6%) and A61P therapeutic-activity claims (25.9%) follow, with C12N genetic-engineering claims present in 15.2% of records — evidence that a large share of lyoprotectant filings are tied to biologic and vaccine products rather than small-molecule freeze-dried drugs alone.
Shares are the percentage of the 4,685 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Lyoprotectants and Freeze Drying Excipients with Eureka
This page is one run against one query. Ask Eureka your own question about lyoprotectants and freeze drying excipients and every answer comes back with the patent numbers behind it.
Try EurekaRepresentative and most-cited filings
US11446250B2 — Lyophilization of RNA
The patent, assigned to CureVac Manufacturing, covers a method for lyophilization of RNA, the resulting lyophilized composition, a pharmaceutical composition, a vaccine, and a kit or kit of parts, together with the use of a lyoprotectant for lyophilizing RNA and the first and second medical use of the resulting compositions.Filed against a backdrop of intense mRNA vaccine formulation activity, this filing sits squarely at the intersection of the A61K and C12N classes that dominate this dataset.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US6267958B1 | Protein formulation | 3,205 |
| 2 | WO1997004801A1 | Stabile isotonic lyophilized protein formulation | 1,403 |
| 3 | US6685940B2 | Protein formulation | 621 |
| 4 | US20040197324A1 | High concentration antibody and protein formulations | 478 |
| 5 | WO2012135408A1 | Stable formulations of antibodies to human programmed death receptor PD-1 and related treatments | 399 |
| 6 | US6875432B2 | Reduced-viscosity concentrated protein formulations | 383 |
| 7 | WO2004091658A1 | High concentration antibody and protein formulations | 354 |
| 8 | WO2017218704A1 | Stabilized formulations of lipid nanoparticles | 319 |
| 9 | US6821515B1 | Protein formulation | 312 |
| 10 | US20030113316A1 | Stable lyophilized pharmaceutical formulation of IgG antibodies | 309 |
Citation counts favour older records simply because they have had more time to accumulate citations within the searched corpus; treat them as a signal of influence rather than of current relevance.
Each row carries its publication number; clicking a row searches Eureka by that number.
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Three patterns stand out once the ranking, the trend and the class composition are read together.
The top of the field is concentrated, the rest is not
The five leading assignees hold 1,209 of the 4,685 records in scope (25.8%), and the top ten hold 1,823 (38.9%). That leaves well over 60% of filings distributed across the remaining ranked entrants and unranked filers, which points to a field where a handful of large biologics and vaccine developers set the pace but do not lock out new entrants.
Filing pace has cooled from its 2020 peak
Filings peaked at 299 in 2020 and had fallen to 142 by 2024, a 38% decline from the 2021 count of 229. Several of the most active historical filers show flat or declining recent-year activity, which is consistent with a formulation approach that has matured rather than one still being rapidly explored.
Formulation claims dominate over process claims
A61K medicinal-preparations claims appear across 85.3% of records, far outweighing more process-specific classes like A61L sterilising (2.4%) or C12P fermentation (2.6%). This suggests most protection in this space is being sought around formulation composition and stabilizer chemistry rather than around drying process equipment or sterilisation steps.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to lyoprotectants and freeze drying excipients, with the prior art for and against each one.
Who is filing, and where the gaps sit
Large biologics and vaccine developers anchor the ranked leaders, with co-filing patterns showing close collaboration between a small number of pharma pairs.
A single biologics developer leads the ranking
The leading assignee holds 327 records, well ahead of the fifth-place holder at 163 and the tenth-place holder at 100. The gap between first and fifth place is wide enough that the field cannot be described as evenly matched among a handful of firms.
Co-assignee pairs cluster around a small number of alliances
Only 10 co-assignee pairs appear in this dataset, and the strongest pair accounts for 107 shared records. The next strongest pairs sit at 39 and 20 records respectively, indicating most collaboration is concentrated in one or two long-running partnerships rather than spread across many joint filings.
Several established filers have gone quiet in the latest year
A number of historically active assignees show zero filings in the latest year, with year-on-year changes of -100% at several of the largest historical filers. Combined with publication lag, this does not necessarily mean these programmes have ended, but it does mean recent competitive activity should be checked against filing behaviour from two to three years earlier rather than the most recent year alone.
| Assignee | Recent year | YoY |
|---|---|---|
| Takeda Pharmaceutical Company Limited | 3 | -50% |
| Shire Human Genetic Therapies, Inc. | 0 | — |
| Genentech, Inc. | 0 | -100% |
| Millennium Pharmaceuticals, Inc. | 0 | -100% |
| F. Hoffmann-La Roche AG | 0 | — |
| GlaxoSmithKline Biologicals SA | 0 | -100% |
| Academia Sinica | 0 | — |
| Novartis AG | 0 | — |
Where to take this analysis
The dataset points to specific next steps for teams deciding where to file or where to design around existing claims.
Map claim scope around the top formulation classes
With 85.3% of records carrying A61K claims, a freedom-to-operate review should start by pulling the specific claim language of the leading assignees' A61K filings rather than treating the class as a single block.
Explore formulation claims in EurekaCheck momentum before assuming a filer has exited
Several major historical filers show zero filings in the latest year; before concluding a company has stepped back from this space, cross-check against its filing history two to three years earlier to account for publication lag.
Run an assignee momentum check in EurekaTest the under-claimed branches directly
Sub-areas like residual moisture control and mannitol polymorph management carry far fewer records than the core A61K classes, making them worth a targeted search before assuming the space is occupied.
Search white space in EurekaCommon questions about this landscape
The dataset ranks 100 assignees by record count, with the leading assignee holding 327 records against 163 for the fifth-ranked entrant and 100 for the tenth. The top five assignees combined hold 1,209 of the 4,685 records in scope, which is 25.8% of the total, while the top ten hold 38.9%. That leaves the majority of filings distributed across a long tail of smaller filers, so leadership at the top does not translate into control of the whole field.
Filings rose from 227 in 2017 to a peak of 299 in 2020, then declined to 229 in 2021 and 142 in 2024, a 38% drop over that three-year span. Figures for 2025 and 2026 are still incomplete because publication typically lags actual filing by around 18 months, so the most recent years should not be read as evidence the field has slowed further. The safest read is that filing activity cooled from its 2020 peak but has not necessarily continued declining at the same rate.
The dominant class is A61K, medicinal preparations, appearing in 85.3% of the 4,685 records in scope. C07K peptides and proteins (28.6%) and A61P therapeutic activity (25.9%) are the next most common, followed by C12N microorganisms and genetic engineering at 15.2%. Because a single record can carry multiple IPC codes, these shares add up to more than 100%, and they show that most protection is sought around formulation composition rather than drying equipment or sterilisation process, which appear far less frequently.
US11446250B2, assigned to CureVac Manufacturing and titled Lyophilization of RNA, covers a method for lyophilizing RNA, the lyophilized composition produced by that method, related pharmaceutical compositions and vaccines, kits containing them, and the use of a lyoprotectant specifically for RNA lyophilization. It was granted in September 2022. Anyone developing RNA-based lyophilized formulations should review its specific claim scope closely, since it sits at the intersection of the A61K and C12N classes that account for a large share of this dataset.
Classes with comparatively low record counts relative to the dominant A61K and C07K formulation classes include A61L sterilising and disinfecting (2.4% of records), C12P fermentation and enzymatic synthesis (2.6%), and G01N material analysis and testing (2.8%). These lower-density branches — covering areas like sterilising-compatible lyoprotectant blends, fermentation-derived stabilizer production, and analytical methods for residual moisture or glass transition measurement — are candidates for narrower claims, though a full freedom-to-operate search is needed before relying on low density alone as a filing signal.
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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.