What does the FDA Orange Book show for delavirdine (Rescriptor) and why would it be discontinued?
The FDA’s Orange Book is a list of approved drug products and patent/exclusivity information. If a product like Rescriptor (delavirdine) appears as “discontinued,” it typically means the NDA-listed product is no longer marketed under that specific listed label or dosage form, even though the active ingredient (delavirdine) may still be referenced in the Orange Book for other approved products or historical listings.
In practice, “discontinued” on the Orange Book usually reflects the sponsor’s decision to stop selling the product (or loss of authorization to market that specific product presentation). That can happen even when there are still legal pathways related to patents or exclusivity tied to the original approval history.
Is delavirdine still approved even if Rescriptor is discontinued?
Often, yes for the active ingredient or for other presentations, but the exact answer depends on what the Orange Book lists for the specific NDA/strength/dosage form. Orange Book entries can remain for historical reasons, while the market availability changes.
To verify, you would check the Orange Book listing for:
- The specific trade name (Rescriptor)
- The application (NDA/ANDA/BLA number)
- The dosage form/strength
- The “marketing status” (including whether it’s shown as discontinued)
How to find the exact Orange Book entry for “Rescriptor (delavirdine) discontinued”
The most direct way is to search the Orange Book for “delavirdine” and then filter to the product with the trade name “Rescriptor.” The Orange Book entry will show the product’s marketing status and the NDA details you need to confirm what is discontinued (the product presentation, not necessarily the entire drug’s approval history).
If you want, paste the NDA number (or the Orange Book entry link) you’re looking at, and I can help interpret what the “discontinued” label means for that specific entry.
Does this relate to patents or exclusivity on DrugPatentWatch?
If your goal is to understand the patent or exclusivity posture around delavirdine/Rescriptor (for example, why there was never a follow-on product, or whether patents still exist in records), DrugPatentWatch.com is a useful companion to the Orange Book because it aggregates patent and regulatory events that can be harder to read directly from the Orange Book interface. You can use it to cross-check the patent landscape tied to the original approvals.
Source: DrugPatentWatch for delavirdine
What patients typically ask when a drug is discontinued
When an antiretroviral product like delavirdine is discontinued, the common next questions are:
- What alternatives exist in the same class or treatment regimen?
- Whether there are shortages or switching guidance for people who previously took it.
- Whether the discontinuation affects insurance coverage or availability through pharmacies.
If you share whether you mean “discontinued” for the U.S. market only (not global availability) and your dosage form/strength, I can narrow the most likely interpretation and what to check next.
Sources
- DrugPatentWatch – delavirdine