See the DrugPatentWatch profile for Golodirsen
What is the Golodirsen “sequence” patent and what does it cover?
Golodirsen is the active ingredient in Vyondys 53 (and related formulations). A “sequence patent” typically refers to intellectual property tied to the exact nucleotide sequence used to generate the drug’s therapeutic oligonucleotide (for example, the specific antisense sequence), rather than broader methods of using antisense oligonucleotides generally. In practice, sequence-linked claims aim to protect the precise construct that is administered to patients.
When does the Golodirsen sequence patent expire?
Patent expiration depends on the specific patent number, jurisdiction (US vs. EP vs. others), and whether any exclusivity periods or extensions apply. “Golodirsen sequence patent” is not enough to determine a date because multiple filings and related patents can exist for different claim scopes (sequence claims, formulation claims, manufacturing/process claims, and combination/use claims).
Which company holds the Golodirsen sequence patent?
Ownership also depends on the specific patent document you mean. Golodirsen development and commercialization are associated with companies in the exon-skipping/antisense space, but the right answer requires the exact patent identifier (publication number or national patent number).
How do these patents affect generic or biosimilar-style competition?
For oligonucleotide drugs like golodirsen, a sequence patent can act as a barrier to “copy” products that use the same protected nucleotide sequence. Even if another product has similar mechanism (exon skipping), sequence-level protection can still block entry unless the challenger designs around the claims (changing the sequence so it is outside the protected scope) or obtains rights through licensing or a successful legal challenge.
What happens if a challenger tries to “design around” the sequence?
If claims are tightly directed to the exact antisense sequence, challengers may need to alter the nucleotide sequence so it falls outside the claimed sequence scope. That can affect potency, binding, and pharmacology, so design-around strategies are often constrained by clinical and regulatory performance requirements, not just legal claim language.
Are there related patents besides the sequence that can still block entry?
Yes. Even if a sequence patent is avoided, other patent families can remain in force, such as:
- formulation and delivery (how the drug is manufactured or administered),
- manufacturing/process methods,
- specific use claims (dosing regimens, patient subsets),
- additional sequence variants or intermediate constructs.
What should you look up to answer “Golodirsen sequence patent” precisely?
To find the correct patent record and expiration date, you need at least one of the following:
- the patent publication number (US publication like “US 20xx…”, or EP/WO publication),
- the patent number (grant number),
- the jurisdiction you care about,
- the assignee/holder name.
If you share the patent publication number or jurisdiction you mean, I can help pinpoint the expiration timeline and summarize what the claims cover.
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Sources
I don’t have the specific patent publication/grant details for “Golodirsen sequence patent” in the information you provided, so I cannot cite authoritative sources or an expiration date without the exact patent identifier.