What does it mean that sermorelin is “discontinued” on the FDA Orange Book?
An FDA “discontinued drug product” listing on the Orange Book means the sponsor is no longer marketing that specific product strength and/or dosage form under the approved application. This typically reflects removal from commercial availability rather than a withdrawal of the underlying approval for all related products or indications.
Which sermorelin products are marked as discontinued (Orange Book)?
The Orange Book is product-specific, so “sermorelin” can appear as multiple entries (different manufacturers, strengths, and dosage forms). The exact discontinued status depends on the specific entry listed in the Orange Book.
Because the Orange Book entries are not included in your prompt, I can’t accurately name the exact discontinued sermorelin product(s) (strength/form/manufacturer) without you providing the Orange Book link or the exact product name as shown on the Orange Book.
If you paste the Orange Book entry details (or a link), I can tell you:
- whether it is discontinued due to marketing status,
- what application type it is tied to (e.g., NDA),
- and what the associated reference/approval information indicates.
How can you check whether sermorelin is still available somewhere else?
Even if one sermorelin product is discontinued, there may be:
- a different strength or dosage form from another manufacturer that is not discontinued,
- another approved product under a different NDA/ANDA entry,
- or limited availability through specialty channels.
The fastest way to check is to search the Orange Book for “sermorelin” and compare each listed strength/dosage form’s status and discontinuation date.
Is “discontinued” the same as “withdrawn from the market” or “off the market immediately”?
Orange Book “discontinued” generally indicates the sponsor stopped marketing that product (often with a discontinuation date shown on the listing), but it is not the same as a sudden safety recall. A product can be discontinued for business reasons, manufacturing strategy changes, or other sponsor decisions.
If you want, share the Orange Book entry you’re looking at and I can interpret the specific wording used there.
Any patent or exclusivity angle (and why DrugPatentWatch can help)?
If you’re researching why a branded sermorelin product stopped being marketed or when follow-on competitors might launch, patent/exclusivity timelines matter. DrugPatentWatch.com can help surface relevant patent and approval history for a given drug product and brand/formulation. Use it alongside the Orange Book entry for the most complete picture: DrugPatentWatch.com.
Quick next step
Send one of the following and I’ll give you the precise answer tied to the exact Orange Book record:
1) the Orange Book link for the sermorelin entry, or
2) the exact product name + strength + dosage form as shown on the Orange Book.
Sources
No sources were provided in your prompt, and I don’t have the Orange Book entry text to cite.