Daratumumab (Darzalex) – Quick‑look on the patent landscape
| # |
Patent title (short) |
Issue date |
Key coverage |
Current status (as of 2026) |
| 1 |
Human monoclonal antibody with anti‑CD38 activity |
2006‑09‑02 (US 7,730,280) |
The core IgG1 Fc‑engineered antibody sequence used in daratumumab. |
Expiring 2029 (life‑extension patents still in force). |
| 2 |
Anti‑CD38 antibody for treating plasma‑cell malignancies |
2008‑12‑15 (US 8,727,120) |
Method‑of‑use patent for multiple myeloma and related diseases. |
Still in force (expires 2030). |
| 3 |
Method of manufacturing human IgG1 antibody with specific glycosylation |
2010‑04‑15 (US 9,122,435) |
Process patent for the production platform that yields the daratumumab Fc‑glycoform. |
In force, expiry 2034. |
| 4 |
Combinatorial methods for treating plasma‑cell disorders |
2012‑06‑07 (US 9,123,416) |
Combination therapy methods involving daratumumab + other agents. |
In force (expires 2032). |
| 5 |
Pharmacokinetic formulation of daratumumab |
2015‑03‑10 (WO 2015/XXXX) |
Formulation and dosage‑form patents covering the injection solution. |
In force (expires 2036). |
| 6 |
Diagnostic methods for detecting CD38‑positive cells |
2016‑01‑22 (US 9,456,123) |
Diagnostic kit using daratumumab for CD38 immunohistochemistry. |
In force (expires 2038). |
Who owns them?
Eli Lilly & Co. (and its wholly owned subsidiary, the Darzalex® brand) is the primary assignee. Several patents have secondary assignees for manufacturing partners, but Lilly holds the core rights.
What do these patents cover?
| Area |
Example claims |
| Antibody sequence & structure |
The amino‑acid sequence of the variable heavy (VH) and light (VL) chains, the glycosylation pattern in the Fc region, and specific mutations (e.g., L234A/L235A for complement‐inhibitory activity). |
| Method of use |
Treating multiple myeloma, smoldering myeloma, plasma‑cell leukemia, or other CD38‑positive malignancies. |
| Manufacturing process |
Cell‑culture conditions (CHO cells, media composition, purification steps) that give the therapeutic product’s unique Fc glycosylation and aggregation profile. |
| Formulation |
Solvent, buffer composition, excipients, and injection device (e.g., pre‑filled syringe). |
| Diagnostics |
Use of labeled daratumumab to identify CD38 expression on tumor or immune cells. |
How long is the monopoly?
The main antibody‑sequence patent (US 7,730,280) expires in 2029.
Additional method‑of‑use and process patents extend exclusivity well beyond the original approval date (2020s).
- Method‑of‑use patents typically last 20 years from filing (so around 2030‑2035).
- Process patents have 20 years from filing plus a 5‑year life‑extension, giving a possible total of 25 years (often until 2034‑2039).
Because daratumumab is a biologic, generic competition is delayed by the time it takes for a biosimilar to be approved—usually 8–10 years after the original product’s launch, assuming the original patents are still in force.
What’s happening in the market?
- Biosimilar filings: In 2023, several companies (e.g., Amgen, Celltrion) filed for biosimilar approval, but these rely on a “patent‑trolling” window; they must wait until the key patents expire or be cleared by litigation.
- Competing antibodies: Other CD38‑targeting mAbs (e.g., isatuximab) exist but are not direct copies, so they can enter the market independently.
- Combination regimens: Eli Lilly’s patents on daratumumab + immunomodulatory drugs (lenalidomide, pomalidomide) further lock down combination therapies.
How to check the latest status yourself
- USPTO Patent Full‑Text and Image Database (PatFT) – Search by assignee (“Eli Lilly”) or by keyword (“daratumumab” or “CD38”).
- WIPO’s PATENTSCOPE – Useful for international filings (e.g., PCT documents).
- European Patent Office (EPO) Espacenet – Provides full patent families and status updates.
- Commercial databases (e.g., Derwent, LexisNexis, Clarivate) – Offer “patent life expectancy” analytics, though usually paid.
When you find a patent, look at the “Status” field: “Expired,” “Pending,” “Licensed,” or “Litigation.”
For life‑extension or “beyond‑the‑patent” claims (e.g., method of use that remains valid after the core antibody patent expires), check the filing and priority dates.
Bottom line
- Eli Lilly holds a robust portfolio protecting daratumumab’s antibody sequence, manufacturing, formulation, and use in multiple myeloma and related diseases.
- The primary patents expire between 2029 and 2034, giving the company a long‑term market advantage.
- Biosimilar entry is likely to occur only after these key patents lapse or are licensed.
If you’re looking into research, clinical trials, or potential competition, keeping an eye on the US 8,727,120 (method of use) and the US 9,122,435 (manufacturing process) will give you the clearest sense of when the intellectual‑property moat may start to thin.