Biopharmaceutical Formulation Patents: Leaders, Trends & Gaps 2026
- Filing activity peaked in 2018 at 25 records and has declined since, with the 2022 midpoint at 11 — this is a maturing claim space, not a growing one.
- Two documents anchor the entire citation graph WO2010056804A1 and WO2009070642A1 draw 166 and 159 citations respectively, far ahead of anything filed since.
- Co-assignment is rare and thin only 10 co-assignee pairs across 130 families, and none exceeds two shared filings — this field is built on solo corporate filers, not joint ventures.
What this landscape covers
This dataset tracks patent families addressing biopharmaceutical, protein and antibody formulation where the claims specifically engage aggregation control, excipient screening, viscosity behaviour at high concentration, freeze-thaw stability or container interaction. The IPC mix is dominated by A61K medicinal preparation classes and C07K peptide and protein chemistry, with a smaller but consistent presence of therapeutic-activity (A61P) and fermentation (C12P) filings that mark formulation work tied to specific drug classes.
Coverage runs from 2015 through the third quarter of 2026, with the most recent year necessarily understated because publication typically lags filing by around eighteen months. Read the 2025 and 2026 bars in the trend chart as a floor, not a ceiling.
Filing trend and technology composition
130 patent families sit inside the search string, filed against a backdrop of receiving offices led by the United States, Australia and the European Patent Office — a filing footprint typical of biologics programmes chasing global regulatory approval in parallel.
A field past its filing peak
Annual filings rose to a peak of 25 in 2018, then eased through the 2022 midpoint of 11 records and have not recovered. That pattern is consistent with a technology area where the foundational formulation platforms — buffer systems, stabilising excipients, standard concentration ranges — were staked out early, leaving later filers to compete for narrower, more specific claim territory.
Concentrated in two IPC subclasses
A61K appears in 126 of 130 records and C07K in 88, confirming that nearly every filing in this set is a medicinal-preparation claim built around a peptide or protein active. A61P, C12P, C12N and A61J appear in a minority of records, marking where formulation claims are tied to a therapeutic indication, a fermentation-derived active, or a delivery container rather than the formulation itself.
Shares are the percentage of the 130 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Biopharmaceutical Formulation and Stability with Eureka
This page is one run against one query. Ask Eureka your own question about biopharmaceutical formulation and stability and every answer comes back with the patent numbers behind it.
Try EurekaThe documents everyone else cites
Stable antibody formulation for intravenous use comprising nivolumab, histidine, sucrose, polysorbate and methionine
The formulation combines roughly 10-40 mg/mL nivolumab with L-histidine buffer, sucrose, polysorbate 80 and L-methionine, and is claimed stable at 2-8°C for about 12 months for use in cancer treatment.Filed by Xbrane Biopharma AB, published 2025-08-21 — illustrates how recent filings narrow claims to a named biologic and a specific excipient combination rather than a broad formulation platform.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | WO2010056804A1 | Antibody formulation | 166 |
| 2 | WO2009070642A1 | Protein formulation | 159 |
| 3 | WO2010032220A1 | Stable liquid antibody formulation | 72 |
| 4 | WO2011084750A1 | Antibody formulation | 45 |
| 5 | WO2007124082A2 | Buffering agents for biopharmaceutical formulations | 36 |
| 6 | US20170232103A1 | Excipient compounds for biopolymer formulations | 26 |
| 7 | WO2018160722A1 | Anti-RSV monoclonal antibody formulation | 25 |
| 8 | WO2019171253A1 | Anti-PD-1 antibody compositions | 21 |
| 9 | WO2017070501A1 | Excipient compounds for biopolymer formulations | 18 |
| 10 | US20160215051A1 | Protein formulation | 16 |
Citation counts are drawn from the searched corpus only and skew toward older filings; treat them as a measure of influence on later drafting, not of current commercial 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 and trend data are read together: concentration at the citation core, a declining filing curve, and almost no collaborative filing.
A small set of early filings still sets the terms
WO2010056804A1 and WO2009070642A1 together account for the bulk of citation weight in this corpus. Both are broad antibody and protein formulation filings from around 2009-2010, and later applicants have had to draft around their buffer and excipient claims rather than compete head-on.
Activity has cooled since the 2018 peak
Filings rose steadily to 25 in 2018, held near the 2022 midpoint of 11, and recent-year momentum tables show zero latest-year filings across every major assignee tracked, including originator biologics houses. That is partly a publication-lag artefact, but the multi-year downward slope predates the lag window.
Formulation IP is filed solo, not jointly
Only ten co-assignee pairings exist across the full set of 130 families, and none repeats more than twice. Compared with fields built on manufacturing consortia or platform licensing, this suggests formulation know-how is treated as proprietary trade secret adjacent to the patent, filed in-house rather than co-developed.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to biopharmaceutical formulation and stability, with the prior art for and against each one.
Who holds the ground
Filing here is led by large-molecule originators with mature antibody pipelines, alongside specialist formulation houses that file narrower, excipient-specific claims. Recent-year momentum has flattened across the board, including for assignees with the deepest historical portfolios.
Historic leaders have gone quiet in the most recent window
Assignees including MedImmune, Pfizer, Genentech and Amgen show zero filings in the latest tracked year in this dataset. Given the publication lag, this likely understates true recent activity, but it also reflects that core buffer and stabiliser claim territory for major antibody classes was staked out years ago.
Smaller formulation specialists compete on narrow claims
Alongside the originator names, formulation-focused entities file claims tied to specific excipient systems or viscosity-reduction methods rather than platform-wide antibody stabilisation, competing for the claim space the earliest filings left open.
New filings narrow to named biologics
The representative 2025 filing from Xbrane Biopharma ties a formulation claim to a single named antibody, nivolumab, with a defined excipient combination and stability window, rather than claiming a broad formulation class — a pattern typical of designing around older platform patents.
| Assignee | Recent year | YoY |
|---|---|---|
| MedImmune | 0 | — |
| Pfizer | 0 | — |
| Genentech | 0 | — |
| MedImmune LLC | 0 | — |
| REFORM BIOLOGICS LLC | 0 | — |
| Amgen | 0 | — |
| United BioPharma | 0 | — |
| Asymchem Pharmaceuticals | 0 | — |
Where to take this analysis
The ranking, trend chart and citation table on this page are a starting point for scoping, not a substitute for a full freedom-to-operate search on a specific formulation.
Run a claim-level comparison against the top-cited records
WO2010056804A1 and WO2009070642A1 carry the heaviest citation weight in this corpus. Any new antibody formulation programme should map its buffer, excipient and concentration ranges against these claims before drafting.
Open Eureka to compare claimsScreen the under-claimed branches for a first-mover position
Container interaction and fermentation-derived stabilisation show thinner claim density than the core antibody space. A targeted search can confirm whether a specific excipient or process combination is genuinely open.
Explore white space in EurekaCommon questions about this landscape
In this landscape, it is a patent family whose claims address how a protein, antibody or other biologic drug substance is stabilised, buffered or delivered — not the underlying molecule itself. Typical claim elements include specific excipients such as sucrose or polysorbate, buffer systems like histidine, concentration ranges, and stability conditions such as storage temperature and shelf life. The search here is further narrowed to filings that explicitly address aggregation control, excipient screening, high-concentration viscosity, freeze-thaw stability or container interaction, which excludes broader manufacturing or delivery-device patents.
The 2018 peak of 25 filings in this dataset coincides with a period when several large antibody classes were moving through late-stage development, generating a wave of formulation patenting around stabilising excipients and buffer systems. The subsequent decline to a 2022 midpoint of 11 filings, and near-zero recent-year activity across tracked assignees, likely reflects both a genuine slowdown as core claim territory filled up and the roughly eighteen-month publication lag that understates the true count for the last one to two years. Readers should treat the most recent bars in any filing trend chart as provisional.
The most-cited records in this corpus, led by WO2010056804A1 and WO2009070642A1 with 166 and 159 citations respectively, function as reference points that later filings have had to draft around. A new formulation claim covering buffer composition, excipient combinations or high-concentration stability should be checked against these documents first, since their citation weight indicates broad, foundational claim scope rather than a narrow niche position.
Yes, though it sits in the narrower branches rather than the core antibody-buffer-excipient space. IPC data shows only a small minority of records touching container interaction, fermentation-derived active stabilisation or genetically engineered host systems, compared with the near-universal presence of A61K and C07K classes. These thinner branches are where a specific, well-drafted claim is more likely to clear a freedom-to-operate check, though that still requires a dedicated search rather than reliance on this summary alone.
Rarely, based on this dataset. Only 10 co-assignee pairings appear across 130 patent families, and the strongest of them share no more than two filings together. That pattern points to formulation development being run as an in-house, proprietary activity within originator companies and specialist formulation firms, rather than through joint ventures or shared licensing arrangements that would show up as repeated co-assignment.
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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.