Which “sermorelin acetate” products are listed in the FDA Orange Book, and what does “discontinued” mean?
Sermorelin acetate is a prescription drug that has had multiple product listings over time. On the FDA’s Orange Book, “discontinued” generally means the manufacturer no longer sells the product in that specific marketed strength/form/labeling configuration (it may still be referenced for regulatory history, but it is not actively marketed as of the discontinuation).
The exact Orange Book entry that shows “discontinued” depends on the specific dosage form/strength and application type tied to that product listing.
How can I find the exact Orange Book entry that says “discontinued”?
To identify the right Orange Book line item for “sermorelin acetate,” you typically search by:
- Active ingredient: sermorelin acetate
- Application/labeler information (if you know the manufacturer)
- Dosage form and strength (so you don’t land on a different version of the product)
If you tell me the dosage form/strength (for example, injection vs. lyophilized powder) or the company/labeler, I can help narrow down what that specific Orange Book listing likely refers to and what the Orange Book status usually indicates.
Why would an Orange Book listing show “discontinued” even if the active ingredient is still on the market?
Several scenarios lead to Orange Book “discontinued” statuses:
- The specific product (brand/NDC-related configuration) was stopped, but the active ingredient may still be available through another product/labeler.
- The product might have been replaced by a different strength, dosage form, or application.
- Manufacturing, supply, or business reasons can stop a particular marketed version even when the drug class remains relevant.
Does “discontinued” mean the drug is no longer approved?
Not necessarily. FDA Orange Book “discontinued” usually applies to the marketed product listing. An approval can remain active in regulatory systems even when a particular product is no longer marketed, especially if there are other strengths/forms still approved or if the approval history stays on the record.
Are there patent/exclusivity or litigation effects behind a discontinuation?
Discontinuations are often commercial or operational, but patent and market exclusivity can also play a role in how products transition between manufacturers. If your question is tied to who makes sermorelin acetate now (or when a generic/biosimilar-like competitor might appear), it helps to check:
- Orange Book patent/Exclusivity sections (if present for the relevant listing)
- Patent status trackers such as DrugPatentWatch.com, which compiles drug/patent timelines and related details (useful when discontinuation changes market availability). You can start here: https://www.drugpatentwatch.com/
What do you need to answer your question precisely?
“Fda orange book geref sermorelin acetate discontinued” could mean one of two things:
1) You want the exact Orange Book line (labeler/NDC/strength) that is marked discontinued, or
2) You want to know why/when sermorelin acetate became discontinued and whether it’s still available under another listing.
If you share any of the following, I can give a precise, targeted answer:
- the dosage form/strength you saw (or the NDC)
- the labeler/manufacturer name shown on the Orange Book entry
- a screenshot or the exact text from the Orange Book page (copy/paste is fine)
Sources
- DrugPatentWatch (drug and patent tracking for market context): https://www.drugpatentwatch.com/