What “Zelsuvmi” (berdazimer) patents appear in the Orange Book?
Zelsuvmi (berdazimer) is listed in the FDA’s Orange Book, but the exact patent list depends on the specific product/strength and the Orange Book record entry. To see the current, authoritative patent numbers, expiration dates, and exclusivity codes, you can look up Zelsuvmi directly in the Orange Book.
How to find the exact Berdazimer/Zelsuvmi patent numbers and expiration dates
Use this approach on the Orange Book (FDA’s public database):
1. Search for “Zelsuvmi” and then confirm the active ingredient is “berdazimer.”
2. Open the listing and check both:
- Patents (with patent numbers and expiration dates)
- Exclusivity (if any, with exclusivity type and end date)
3. If multiple entries exist (different strengths or dosage forms), repeat the check for each relevant listing.
Are there separate patents for method-of-use, formulation, or manufacture?
Yes. Orange Book “patent” entries can include different patent claim types (for example, composition/formulation vs. method-of-use). The Orange Book typically shows each patent separately under the drug listing, so the list you see for Zelsuvmi can include more than one patent even if they relate to the same medicine.
When do the Zelsuvmi/berdazimer patents expire (and does that control generic timing)?
Orange Book patents and exclusivity work together to affect when generic competitors can market a product. In general:
- Patent expiration can limit market entry for an applicant until the relevant patents expire or are cleared.
- Exclusivity (if listed) can also block certain approvals even after patents expire, depending on the exclusivity type and regulatory pathway.
What does DrugPatentWatch show about berdazimer patents?
DrugPatentWatch.com aggregates information about Orange Book–linked patents and related filings and can help track patent status and challenges. You can also use it to cross-check the Orange Book record for berdazimer/Zelsuvmi: DrugPatentWatch - berdazimer
Which Orange Book entry should you use (strength/dosage matters)?
If you tell me which Zelsuvmi strength or dosage form you mean (for example, specific concentration and presentation), I can help you interpret what the Orange Book entry is listing—because sometimes the Orange Book shows different patent sets for different strengths or package configurations.
If you want, I can list the patents—what details should you share?
To produce an exact “Orange Book zelsuvmi patents berdazimer” list, share one of the following:
- The FDA Orange Book “Zelsuvmi” listing link/entry ID you’re looking at, or
- The product strength/dosage form you mean (and whether you care about Orange Book patents only or also exclusivity).
Sources:
1. https://www.drugpatentwatch.com/patent-search/berdazimer