Quick‑look: What’s going on with Darzalex (daratumumab) and its patents?
| Issue |
Status / Timeline |
| Original U.S. patents (for daratumumab as a drug product) |
Expires 2028–2030, depending on the specific claim and region |
| Key “biosimilar” patents |
Most of the patents that shield the company from biosimilar competition expired in late 2024 in the U.S. |
| Biosimilar launch in the U.S. |
First U.S.‑approved biosimilar, Darzalex Bra (daratumumab‑buh)**, entered the market in early 2025 (FDA approval in 2024) |
| Biosimilar launch in Europe |
The EU granted approval for a daratumumab biosimilar (brand Darzalex Sar or similar) in 2024 |
| Pricing impact |
Prices for the originator have already dipped slightly; the biosimilar is priced 10–20 % lower, but exact savings depend on payer negotiations and rebates |
Why the patent expiration matters
-
Patent protection vs. biosimilarity
A patent gives a company exclusive rights to sell a drug. Once those patents expire, generic or biosimilar manufacturers can enter the market.
- For biologics like daratumumab, “generic” is replaced by biosimilar—a drug that is highly similar in safety, purity, and potency but not identical to the original.
-
Timing of the biosimilar launch
Darzalex’s key patents on the drug’s structure and method of use lapsed in 2024. That opened the door for a biosimilar, and the FDA approved one in late 2024, so the first real competition hit the U.S. market in 2025.
-
Pricing strategy for the originator
The manufacturer (Bristol‑Myers Squibb) typically lowers its list price a few percent after a biosimilar comes out, in order to stay competitive and keep insurers from shifting their bulk of prescriptions to the cheaper alternative. However, the actual savings that patients and payers see depend on rebates, formulary placement, and the “tier” the drug sits on.
What the numbers look like (roughly)
| Drug |
Avg. Wholesale Acquisition Cost (AWAC) 2023 |
Estimated Price 2025 (pre‑rebates) |
| Darzalex (originator) |
~$140 k–$160 k per year |
~$132 k–$148 k (≈ 3–5 % drop) |
| Darzalex Bra (biosimilar) |
– |
~$112 k–$132 k (≈ 10–15 % lower) |
- Biosimilar savings: For a 5‑year course, a patient could save roughly $20k–$30k.
- Payer rebates: Many insurers negotiate rebates that can bring the “net cost” down even more—often 10–25 % of the list price for the originator, and 0–5 % for the biosimilar.
Why the change matters to different players
| Stakeholder |
How it feels |
Why it matters |
| Patients |
Potentially less out‑of‑pocket if their insurance covers the biosimilar or if the insurer shifts to it. |
Out‑of‑pocket costs can be a big burden for multiple‑myeloma treatment. |
| Payers (insurance, Medicare/Medicaid) |
More bargaining power; can push for the cheaper biosimilar as the preferred option. |
Saves money on the drug spend, helps manage formularies. |
| Hospitals/Pharmacies |
May see a shift in how they bill for the drug and how they manage inventory. |
Less risk of being caught with a high‑cost drug that is now less competitive. |
| BMS (originator manufacturer) |
Needs to balance price cuts against revenue loss while maintaining market share. |
The company’s profitability is linked to how much of the market it can keep. |
What’s happening right now?
- Payers are already negotiating: In many U.S. health plans, daratumumab biosimilars are being added to the “preferred” tier or are already in place.
- Formulary shifts: Early adopters have moved the originator to a higher tier (e.g., Tier 4–5) and the biosimilar to a lower tier (e.g., Tier 2).
- Clinician choice: Physicians are increasingly comfortable prescribing the biosimilar because the FDA’s biosimilarity studies show comparable safety and efficacy. However, some clinicians still prefer the originator for certain high‑risk cases or due to familiarity.
Bottom line
- The patent expiration for Darzalex in 2024–2025 allowed the first U.S.‑approved biosimilar to launch.
- Pricing impact: The originator’s list price has already dropped modestly; the biosimilar is about 10–15 % cheaper on a list‑price basis.
- Real‑world savings for patients and payers will depend on rebates and formulary positioning, but most expect a 10–20 % net discount compared to the pre‑biosimilar era.
Quick FAQ
Q1: Will the originator stop being sold?
A1: No. BMS continues to sell Darzalex, but it may be priced higher or placed on a more restrictive tier to encourage switching to the cheaper biosimilar.
Q2: Is the biosimilar as safe as Darzalex?
A2: Yes. FDA approval requires rigorous comparability studies, and post‑marketing surveillance has found no significant safety differences.
Q3: Can a patient request the cheaper biosimilar?
A3: Payers usually determine the preferred drug. Patients can ask their provider about the biosimilar, and many payers allow a “prior‑authorization” request if the biosimilar is not the default choice.
Q4: Will the prices keep falling?
A4: Prices will likely continue to stabilize at a new equilibrium. The originator might see a modest price adjustment (a few percent), while the biosimilar may remain at 10–20 % lower than the original list price, with further reductions possible if more biosimilars enter the market.
Need more details?
Let me know if you’d like specific numbers for a particular payer, country, or treatment line, or if you want to explore how the price changes might affect a specific insurance plan.