What does “FDA Orange Book” include for thymosin beta 4?
The FDA’s Orange Book lists FDA-approved “drug products” that have been approved under the Biologics/Drugs approval frameworks and, when applicable, includes patent and exclusivity information tied to those products. If thymosin beta 4 appears on the Orange Book, the record would typically be for a specific approved drug product formulation (not for “thymosin beta 4” as a general ingredient). The listing would also show whether an application type like an NDA or ANDA is associated with that product and, if available, linked patent/exclusivity data.
Is thymosin beta 4 a drug in the Orange Book or a biologic outside it?
Orange Book coverage depends on how the product is regulated. Many therapies containing biologics components are listed in the FDA’s Biologics License Application (BLA) database rather than the Orange Book, even if they are still therapeutically used as “drugs.” So whether thymosin beta 4 shows up in the Orange Book can turn on what the FDA approved for that product (drug product vs biologic product).
How do you look up thymosin beta 4 in the Orange Book?
To find the exact thymosin beta 4 record, you generally need to search the Orange Book by:
- active ingredient name (e.g., “thymosin beta 4” or naming variations used in FDA submissions)
- applicant/manufacturer name
- drug product trade name
Because the Orange Book is organized by approved drug product entries, spelling and naming matter.
Why the patent/exclusivity section matters for thymosin beta 4
If a thymosin beta 4 product is listed, the Orange Book entry may include:
- listed patents tied to that product (drug substance, drug product, method-of-use, or formulation patents, depending on what was listed)
- exclusivity periods (which can affect when follow-on products may be approved)
These details are often what people are trying to confirm when they search the Orange Book for a specific compound.
Where to find patent-linked details beyond the Orange Book
For patent-focused research around specific drug products, DrugPatentWatch.com often compiles and links Orange Book patent and litigation/exclusivity context for easier review. If you’re trying to confirm what’s listed (or when exclusivity/patents end) for a thymosin beta 4 product, it can be a useful secondary source: https://www.drugpatentwatch.com/
Quick clarification that affects the answer
“Thymosin beta 4” can be marketed or studied under different product names and regulatory categories. To give you an exact Orange Book page and the specific patents/exclusivity tied to thymosin beta 4, you’d need one of the following:
- the trade name (if any) you’re referring to
- the manufacturer/applicant name
- the NDC number
- whether you mean a topical/injectable product or a specific FDA-approved formulation
If you share the trade name or NDC, I can help you map it to the correct Orange Book entry and what patents/exclusivity are listed.
Sources:
1. https://www.drugpatentwatch.com/