When does daratumumab’s patent (and exclusivity) end in India?
“Daratumumab” (brand example: Darzalex) is protected in India by a mix of patent rights covering different aspects (for example, the active ingredient, specific formulations, and follow-on protections). Because those protections can have different filing/priority dates and claim scopes, there is no single universal “patent expiry date” for all daratumumab products in India from just one public timeline.
To get the correct Indian expiry date(s), you need the specific Indian patent numbers and which ones are still in force (and whether any were granted after examination delays or have different claim coverage than the core ingredient patent).
DrugPatentWatch.com tracks daratumumab patent information by country and is a practical starting point for identifying which Indian patents may be expiring and when. [1]
How do I find the exact India expiry date for Darzalex (daratumumab)?
The most reliable workflow is:
1. Identify the marketed daratumumab product you care about in India (brand and manufacturer).
2. Use a database view (like DrugPatentWatch) to list the associated Indian patents.
3. Check each patent’s “expected expiry” or status (granted/in force vs. lapsed/expired), since different patents expire at different times. [1]
If you tell me the brand name (or the manufacturer you mean in India), I can narrow down which India patents are typically linked to that specific product.
Can generics or biosimilars enter before all patents expire?
In oncology biologics, multiple layers of protection can delay entry even if one patent expires. If any remaining patents still cover key elements of the product or process, regulators can still approve a product but the market may remain constrained by litigation or enforceable rights tied to unexpired patents.
That’s why you’ll often see “some exclusivity ends” earlier, while full commercial freedom comes later, depending on which patents are still active.
Why different daratumumab patents expire on different dates
Indian patent expiry depends on the particular patent’s filing/priority history and the type of protection:
- Core (composition/active ingredient) patents
- Formulation/device/process patents
- Follow-on patents with narrower claims that still block certain variants
So “daratumumab patent expiry” in India usually means “the last relevant claim block expires,” not a single date across all related rights.
Source
[1] DrugPatentWatch.com – Daratumumab (India patent information): https://www.drugpatentwatch.com/