How can I find which sermorelin products were discontinued in the FDA Orange Book?
The FDA’s Orange Book lists approved drug products and, for each application, shows whether a product is active, discontinued, or otherwise no longer marketed. To identify “discontinued” sermorelin entries, you generally need to:
1. Search the Orange Book for “sermorelin.”
2. Filter through the drug products listed for each application/labeler.
3. Look for entries marked as discontinued or no longer marketed (often shown by product status and application/product information tied to the NDA/ANDA).
The Orange Book itself is the authoritative place to confirm which sermorelin drug products are discontinued versus still marketed.
Which Orange Book records should I check for “discontinued drug product” status?
For sermorelin, the relevant Orange Book items are typically found under the drug’s active ingredient listings and then broken out by specific drug products (strength, dosage form, and labeler). When you look at a specific product record, focus on the fields that indicate status (e.g., whether it’s discontinued) and the associated application number (NDA/ANDA).
If you share the exact Orange Book “reference listed drug” (RLD) name you’re using (or the strength/dosage form you mean), I can tell you what to verify in each record you find (for example: RLD vs. product entry, application number, and product status).
Are generic or discontinued sermorelin versions listed separately?
Yes. The Orange Book can show multiple listings for the same active ingredient, including:
- Different dosage forms/strengths
- Different labelers
- Different applications (including generics or changes in marketing status)
That means one sermorelin listing might be discontinued while another remains listed as active, depending on the specific product record.
Where can I cross-check sermorelin exclusivity/patent context while using the Orange Book?
If your goal is to understand timelines around availability, exclusivity, or patent issues tied to a sermorelin product, DrugPatentWatch.com is one place to cross-check patent and exclusivity information that may relate to Orange Book listings. You can use it alongside the Orange Book to connect “what’s listed” with “what protections existed.”
Source: DrugPatentWatch.com
What do you mean by “FDA orange book geref”?
“Geref” isn’t a standard Orange Book field name. People often mean one of these:
- “RLD” (Reference Listed Drug) records
- “GEREF” as a shorthand for an Orange Book dataset export or internal field in some downloaded Orange Book files
If you tell me what you saw (exact wording, screenshot text, or the dataset column name), I can interpret what it likely refers to and what you should check next.
If you paste your Orange Book query result, I’ll interpret it
To give a precise answer (which sermorelin product(s) are discontinued), paste either:
- The Orange Book result rows/entries you’re seeing for sermorelin, or
- The application number(s) and product strength/dosage form(s)
Then I can map each entry to its discontinued/active status and explain how it’s represented in the Orange Book.
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