What orange book entries were deleted for empagliflozin, and why do deletions happen?
“Orange Book deletions” generally refer to a change in the U.S. FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book), where listed patent-related records tied to a drug product are removed. Deletions can occur for several reasons, including:
- A patent term ending or a listed patent no longer being eligible for Orange Book listing
- Loss of enforceability (for example, a court decision affecting the patent)
- A company voluntarily removing records after patent status changes
- Expiration of marketing exclusivity or other listed exclusivity periods tied to the submission
The specific “which patents were deleted” and “effective dates” depend on the exact Orange Book product (brand strength/formulation) and whether you’re looking at drug-substance, drug-product, or method-of-use patents.
Which empagliflozin product/version are you looking at?
Empagliflozin has multiple marketed products and strengths (and the Orange Book can track different patent records by application). Deletions are not always uniform across every listing, so the most useful next step is to confirm:
- The exact Orange Book “Drug Name” you mean (brand name vs generic listing)
- The dosage form and strength
- The application type (NDAs vs ANDAs) if you’re comparing generic challenges
If you tell me the brand name (for example, Jardiance) and the strength/form, I can narrow the search-intent from “empagliflozin” broadly to the relevant Orange Book line items.
Are there patent-expiration dates or exclusivity windows tied to those deletions?
Orange Book deletions often track with real-world timeline events like patent expiry or a status change that affects market exclusivity. If your goal is to estimate when generics might enter, deletions can be a helpful signal, but they don’t always mean “no protection remains,” because other listed patents (not deleted) may still block generic entry.
How to verify the deletions in the Orange Book (and interpret the record history)
To confirm empagliflozin Orange Book deletions reliably:
1. Search the Orange Book for the specific empagliflozin product/strength.
2. Check the “Patents” section for the patents that previously appeared.
3. Look for record history or updates showing removal dates (Orange Book updates can reflect new patent status).
4. Cross-check with litigation/patent-watch databases when available, since those often summarize the practical significance of each listing change.
DrugPatentWatch.com is one place people use to track patent listings and related updates for drugs like empagliflozin, and it can help map Orange Book changes to specific patents and dates. You can use it as a cross-reference: https://www.drugpatentwatch.com/
What if you’re asking because you want to know if generics can launch now?
Orange Book deletions alone don’t guarantee generic launch eligibility. Generic entry depends on whether an ANDA can be approved and whether any “remaining blocking patents” are still listed and enforceable for the specific product. If you’re trying to answer “can a generic launch now,” the right follow-up is:
- Which specific Orange Book patents were deleted vs still listed?
- Are remaining patents listed as “method of use” or other blocking categories?
- Is there active litigation that changes enforceability timing?
What I need from you to give exact “deleted patent(s)” for empagliflozin
Please provide one of the following, and I’ll narrow to the precise deletions:
- The brand/product name and strength (e.g., empagliflozin/Jardiance and which strength), or
- The Orange Book “Drug Name” as it appears in the Orange Book, or
- The patent number(s) or patent type you’re tracking (drug substance / drug product / method of use)
Sources cited:
1. DrugPatentWatch.com (empagliflozin patent tracking)