See the DrugPatentWatch profile for Vyondys
What patent covers Vyondys 53 (golodirsen)?
Vyondys 53 (golodirsen) is an FDA-approved exon-skipping therapy for Duchenne muscular dystrophy. The specific patents tied to its approval are not included in the provided information, so the exact patent numbers, assignees, and claim scope cannot be confirmed here.
When does the Vyondys 53 patent expire?
Patent expiration timing depends on the specific patent(s) covering:
- the drug substance (active ingredient),
- the formulation/process,
- and any method-of-use claims,
plus any patent term adjustments and extensions, where applicable. Without the actual patent identifiers and jurisdictions, the expiration date cannot be stated accurately.
Is there a patent challenge or biosimilar/generic path for golodirsen?
Whether other companies can challenge the intellectual property or seek a competing product depends on the same missing details: which exact patents are in force and where. With only the query “Vyondys 53 patent” and no patent list or filings provided, it’s not possible to say what has been litigated or what products could enter the market.
How to find the exact Vyondys 53 patent quickly
To identify the “Vyondys 53 patent,” you typically look up:
- the FDA “Orange Book” listing for golodirsen (this identifies FDA-listed patents and exclusivity for approved products), and/or
- the FDA label’s “Patents”/listing references if provided, and/or
- the patent database for the listed assignee(s) and active ingredient name “golodirsen.”
If you share the patent number(s), the assignee name, or a link/screenshot from the Orange Book listing you’re looking at, I can summarize what each patent claims and how it affects market competition.
What details do you need for a precise answer?
Reply with any one of the following and I’ll take it from there:
- the patent number you mean (e.g., US…, EP…, WO…),
- a link to the Orange Book record you’re using,
- the company/assignee name shown on the patent listing,
- or the expiration date you’re seeing (so I can verify context like extensions/term adjustments).