When does Alecensa (alectinib) patent protection expire?
The exact expiration date depends on which specific patent(s) and jurisdictions apply (drug substance, formulations, specific methods of use, and related exclusivity periods). Patent expiration is not a single universal date for all “Alecensa patents,” and it can be different from regulatory exclusivity timelines.
How can I find the actual Alecensa patent expiration date for the U.S.?
In the U.S., the most practical way to identify the relevant “Alecensa patent expiration” date is to look up the patents listed for Alecensa in the FDA’s Orange Book, which ties specific patents to the approved drug and tracks the associated expiration dates. Those dates are then used by generic and biosimilar applicants in the FDA’s patent-certification process.
What about “exclusivity” vs “patent expiration” for Alecensa?
Even after the first patent listed for a drug expires, other patents may still block generic entry, and separate regulatory exclusivity periods can delay approval. For a complete timeline, you typically need both:
- the expiration of each relevant Orange Book patent, and
- any applicable regulatory exclusivity periods tied to the product.
Why does the Alecensa expiration date vary by indication or formulation?
Alecensa was approved for different uses over time, and companies may list additional patents as new clinical data support expanded indications or changes in manufacturing/formulation. That means the “earliest” date to watch can differ depending on which indication (and which product listing) you care about.
What happens to generic entry once the first patent expires?
Generic companies usually look for the earliest date when they can legally obtain approval based on patent certifications. If any listed patent still hasn’t expired (or remains protected by relevant exclusivity), a generic approval can be delayed even if some earlier patents expire.
Can you give the specific Alecensa expiration date?
I can provide the specific date(s) if you tell me:
1) the country (U.S., EU, UK, etc.), and
2) whether you want the earliest relevant patent expiration for generic entry, or the expiration of a particular listed patent number.
Sources
I don’t have the underlying Alecensa patent list or Orange Book entries in the provided material, so I can’t quote the exact expiration dates without you specifying a jurisdiction or providing the patent numbers/list you’re looking at.