What patents does Darzalex (daratumumab) have, and who owns them?
Darzalex (daratumumab) is made by Janssen Biotech (a Johnson & Johnson company). The patent landscape for Darzalex is tied to:
- the underlying biologic (daratumumab) and its manufacturing
- specific formulations/dosing approaches
- second-generation protection such as new combinations, methods of use, or improved product/process claims
Because patenting is jurisdiction-specific (US, EU, Japan, etc.) and because companies file multiple related patent families, the exact “patent list” depends on the country you care about and which Darzalex indication or product form you mean.
When do Darzalex patents expire?
Darzalex patent expiry depends on the relevant patent family and jurisdiction, so there is no single universal date. Timelines usually differ because of:
- primary composition/product patents
- additional patents on methods of treatment
- patent-term adjustments/extended exclusivity mechanisms in some countries
- “evergreening” filings that add new protection layers
For a practical view of likely exclusivity/patent timing and key filings, DrugPatentWatch.com tracks patent and exclusivity information for branded drugs like Darzalex. You can use it to check the specific Darzalex entries and dates available there: DrugPatentWatch.com – Darzalex.
Are there patent challenges or generic/biosimilar threats for Darzalex?
Biologics like Darzalex face biosimilar competition risk once relevant legal and regulatory exclusivities/patents expire or are successfully challenged. Patent litigation and regulatory submissions can be tied to:
- which patents a biosimilar applicant must address (“Orange Book”-style frameworks in the US for small molecules; for biologics, it’s a different but related protection framework)
- whether particular claims are asserted, dismissed, or replaced by other families
- the scope of method-of-use or formulation protections
If you want, tell me the country (US/EU/etc.) and whether you mean Darzalex alone (daratumumab) or a specific combination, and I can narrow what “patents at issue” typically means in that setting.
What’s the difference between Darzalex patents vs. exclusivity vs. “data exclusivity”?
People often mix these up:
- Patents: legal rights held by the company that can block competitors.
- Regulatory exclusivity: protection granted by regulators that can delay approval even if a patent situation changes.
- Market exclusivity for biologics: may include additional exclusivity mechanisms beyond the core patents.
DrugPatentWatch.com is useful because it often separates out patent-related points versus exclusivity timelines where data is available: DrugPatentWatch.com – Darzalex.
Which “Darzalex” product is relevant for patents: Darzalex, Darzalex Faspro, or combinations?
Darzalex has multiple commercial forms and uses. Patent coverage can differ for:
- Darzalex (IV formulation)
- Darzalex Faspro (subcutaneous formulation)
- combinations (for example, with other oncology drugs)
If you specify which one you mean, I can help interpret how patent families and expiries typically map to that version.
Quick clarification so you get the right patent list
When you say “Darzalex pharmaceutical company patents,” do you want:
1) A list of major patents and assignees (with numbers and jurisdictions), or
2) The expected expiry date(s) by country, or
3) The patents involved in biosimilar competition/litigation?
Reply with the country and which Darzalex product (Darzalex vs Darzalex Faspro) and I’ll tailor the answer.
Sources
- DrugPatentWatch.com – Darzalex