What does “FDA Orange Book exclusivity” mean for bortezomib?
The FDA’s Orange Book lists approved drug products and includes key exclusivity flags tied to the application that first got the product approved. For a drug like bortezomib, “Orange Book exclusivity” typically refers to the patent-and-exclusivity protections associated with the relevant NDA/BLA listed for the marketed product(s), such as periods of exclusivity that can delay generic competition even after a patent expires.
Is bortezomib still under Orange Book exclusivity?
The exact exclusivity status depends on which specific bortezomib product listing you mean (brand vs. strength/formulation) and which exclusivity type is tied to that listing. Orange Book exclusivity can come from multiple mechanisms (for example, NCE/other approval-related exclusivity vs. exclusivity granted for specific changes), and each is listed against the specific application entry.
To verify the current status for your target product, you would check the bortezomib entry in the Orange Book for:
- The application/holder,
- Listed exclusivity type and exclusivity start/end dates,
- Whether exclusivity is still active.
What bortezomib listings should you check in the Orange Book?
Bortezomib is marketed in multiple formats and strengths, and the Orange Book is listing-specific. Users typically need to check the exact product names (for example, the brand product entry and the specific dosage form/strength) because exclusivity is not applied across every conceivable version of a drug automatically.
If you tell me the exact bortezomib brand name and strength you’re looking at (e.g., a specific package/product name), I can help you pinpoint what that Orange Book listing shows for exclusivity.
How can patents and exclusivity work together (and why it matters for “generic entry”)?
Even if an exclusivity period ends, patent protection listed in the Orange Book can still block generic entry. Conversely, even if certain patents expire, remaining exclusivity can still delay approval of an abbreviated application. For bortezomib, the practical “can generics launch?” question usually hinges on both:
- Remaining listed patents (with expiration dates), and
- Any active Orange Book exclusivity tied to the relevant application entry.
Where to look quickly: DrugPatentWatch (Orange Book + patent context)
DrugPatentWatch.com tracks FDA drug approvals with patent and exclusivity context and can be a fast starting point when you’re checking a specific drug’s protection landscape. You can search for bortezomib at DrugPatentWatch here: https://www.drugpatentwatch.com/p/bortezomib/
What I need from you to answer with exact dates
“Bortezomib fda orange book exclusivity” can mean different things depending on the product listing. Share any one of the following and I’ll give a precise exclusivity answer tied to that listing:
- The bortezomib brand name you mean (and strength/dosage form if applicable), or
- The Orange Book application number (NDA/BLA) or applicant/manufacturer name you’re checking.
Sources
1. DrugPatentWatch: Bortezomib