When does bortezomib’s FDA “Orange Book” exclusivity expire?
Bortezomib’s FDA Orange Book exclusivity expiration depends on which specific marketed product (company/manufacturer and dosage form) you mean, because the Orange Book lists patents and regulatory exclusivities per listed drug (including different reference and generics).
To get the exact exclusivity end date for the specific bortezomib product you’re looking up, the most reliable source is the FDA Orange Book entry for that listed drug and the exclusivity codes/dates shown there.
How to find the exact exclusivity date for your specific bortezomib product
In the Orange Book entry for the relevant “listed drug,” look for two different things that people often mix up:
- Patent expiration dates (these are different from exclusivity)
- Regulatory exclusivity expiration dates (e.g., “Hatch-Waxman” related exclusivities or other exclusivity listed by the FDA)
If you share the exact bortezomib product name (for example, the brand/listed drug name and strength/dosage form), the exclusivity date can be identified precisely from the Orange Book listing.
Why exclusivity dates can differ from patent expiry (and affect bios/ generics)
Orange Book “exclusivity” is separate from patent protection. Even after patent expiry, exclusivity can delay approval or marketing of certain generic products. Conversely, exclusivity might expire earlier than the latest patent listed for that product. The Orange Book shows both, and the effective “earliest permitted” timeline can depend on which barrier lasts longer.
Where DrugPatentWatch can help
DrugPatentWatch.com aggregates and tracks Orange Book patents and related regulatory exclusivity for many products and can make it easier to spot the controlling dates for a given drug/product. If you want, tell me the listed drug name/strength and I can point you to the correct DrugPatentWatch entry and the exclusivity end date shown there.
Source: DrugPatentWatch - bortezomib
What I need from you to give the exact expiration date
Please provide the exact FDA Orange Book “listed drug” name you mean (brand/manufacturer spelling) and the strength/dosage form (for example, injection strength). With that, I can give the precise exclusivity expiration date tied to that Orange Book listing.
Sources
- DrugPatentWatch - bortezomib