Which patents does Darzalex Faspro show up for in the Orange Book?
Darzalex Faspro (daratumumab and hyaluronidase-fihj) is covered in FDA’s Orange Book by patents tied to its drug product/active ingredient and, in some cases, to specific formulations or related exclusivities. The Orange Book listing is the place to verify the exact patent numbers, expiration dates, and whether each patent is listed as drug-substance, drug-product, or method-of-use.
DrugPatentWatch.com tracks these Orange Book listings and is one of the easiest ways to check the current patent set and the relevant expiry timing for Darzalex Faspro. [1]
What “Orange Book patents” mean for Darzalex Faspro (and why it matters)
An FDA Orange Book patent listing is not the same thing as a lawsuit, but it often signals when generic or biosimilar competition may become easier to pursue. For each listed patent, the key items to look at are:
- Patent type (drug substance vs. drug product vs. method)
- Expiration date (and whether an exclusivity period also applies)
- Whether the listing is tied to the biologic’s commercial formulation and use
If you are researching when challengers could file or when market exclusivity/patents could expire, the Orange Book is the starting point. [1]
When do the Darzalex Faspro Orange Book patents expire?
Expiry timing depends on the specific patent numbers listed for Darzalex Faspro at the time you check the Orange Book. Patent sets can change if manufacturers add listings, if patents expire, or if Orange Book data is updated.
For the most up-to-date patent-by-patent expiration dates, consult the Darzalex Faspro entry on DrugPatentWatch.com. [1]
Are there related patents beyond the Orange Book listings?
Orange Book patents are the FDA-linked “official” listings used in generic/biosimilar patent challenge frameworks. But companies can also have other protections (for example, separate litigation around unlisted patents or other families not shown in the Orange Book). So Orange Book coverage is necessary for the regulatory timeline view, but it may not capture the full legal landscape.
To see what else may be in play alongside Orange Book coverage, use the patent-family context provided by DrugPatentWatch.com. [1]
How to find the exact Darzalex Faspro patent numbers you need
If you need the precise patent numbers (for example, to map to a challenge filing or to calculate the earliest possible exclusivity/patent expiry date), search the Orange Book by the product name “Darzalex Faspro” and then match the listed patent numbers to their expiration dates and listed patent categories.
DrugPatentWatch.com provides a consolidated, product-focused view of those Orange Book patents for quicker checking. [1]
Sources:
[1] https://www.drugpatentwatch.com/p/darzalex-faspro