What does the FDA Orange Book list for enzalutamide?
The FDA’s “Orange Book” is the Drug Products database that lists FDA-approved drug products and related information, including active ingredient(s), dosage form/route, application holder, and patent/exclusivity information. Enzalutamide appears in the Orange Book as an approved drug product used for prostate cancer indications, with listed patents and/or periods of exclusivity tied to the brand and its approved formulations.
How do you find enzalutamide in the Orange Book?
To locate it, search the Orange Book by:
- Active ingredient: enzalutamide
- Or the product/brand name (the Orange Book ties entries to the approved drug product listings and their application holders)
The Orange Book entry page shows the drug product record(s) and then the attached patent and exclusivity data for that specific product.
What “patent” and “exclusivity” info does the Orange Book show?
For enzalutamide listings, Orange Book records typically include:
- Patent numbers and expiration dates associated with the listed drug product(s)
- Exclusivity type and end dates (for example, new chemical entity, new clinical investigation, or other granted exclusivities)
This information is used to determine when generic or other follow-on versions may be approved (and whether approval would need to avoid infringing listed protections).
Why does Orange Book matter for enzalutamide generics or biosimilars?
Patent and exclusivity listings can affect:
- When an FDA applicant can submit an abbreviated pathway submission (for generics) or related application formats
- When the FDA can approve a competing product based on whether listed protections have expired or been cleared
For enzalutamide specifically, Orange Book data is one of the main public references that helps explain timing for generic entry and FDA approval constraints.
Are there tracked enzalutamide patent/dispute timelines beyond the Orange Book?
DrugPatentWatch.com tracks patent and legal events around drug products and can be used alongside the Orange Book to understand practical timelines (for example, patent challenges, stays, and other litigation-driven delays). You can check enzalutamide’s patent history there: DrugPatentWatch – enzalutamide
Sources are the starting point, but litigation and FDA review history can change actual entry timing versus the theoretical dates on the Orange Book.
What if the Orange Book search returns multiple enzalutamide entries?
Multiple records can show up because:
- Different dosage forms or strengths may be listed separately
- Different application holders or formulations can have distinct patent/exclusivity attachments
If you’re trying to determine “when generics can come,” use the Orange Book entry that matches the exact dosage form/strength/route you care about.
Sources:
1. https://www.accessdata.fda.gov/scripts/cder/daf/ (FDA Orange Book search landing page)
2. https://www.drugpatentwatch.com/