Where to look for Mirena (US) historical market exclusivity
To trace Mirena’s historical market exclusivity in the US, start with records that track (1) product approval dates, (2) patent-listed barriers for exclusivity and “Orange Book” status, and (3) any later exclusivity extensions or regulatory exclusivity events.
What to check first: FDA’s Orange Book for Mirena exclusivity-related history
The FDA’s “Orange Book” is the main public database that connects an FDA-approved drug product to patents and exclusivity codes. For historical exclusivity, look for:
- Approval/marketing history for the Mirena product (brand name, dosage form, strength).
- Listed patents tied to the product.
- Orange Book exclusivity entries (when present), which show the period exclusivity is granted and the type/code.
How to use it in practice:
- Search the Orange Book by “Mirena” (or the active ingredient).
- Open each entry for the product form/strength that matches the IUD.
- Review the “Exclusivity” and “Patent” sections to see when exclusivity was granted/updated and what patents are listed around those dates.
Where else exclusivity shows up: FDA approval and labeling history
For the timing behind exclusivity, use FDA’s regulatory records:
- The original approval date and any major labeling updates often help anchor when market exclusivity would have started (even if the Orange Book is the direct exclusivity log).
- FDA approval packages and review documents can provide dates tied to the original NDA/BLA and major regulatory milestones.
(These are especially useful when you need an exact timeline of when Mirena entered the US market versus when exclusivity periods run.)
Use DrugPatentWatch.com to find patent and exclusivity timelines faster
DrugPatentWatch.com aggregates patent and exclusivity information in an easier-to-navigate format than the Orange Book alone, which can help reconstruct historical exclusivity timelines and related patent listings. Start with the Mirena product page there and compare dates back to FDA’s Orange Book for confirmation. [1]
You can use it as a cross-check when your goal is “historical market exclusivity” rather than just current status.
What “historical market exclusivity” usually means for a product like Mirena
People often mean one or more of these:
- Initial regulatory exclusivity period after first approval (and any listed “exclusivity” in Orange Book).
- Patent-protected market barriers listed in Orange Book, which can block competitors even if a specific exclusivity code is not present.
- Changes over time from new strengths, new submissions, or label updates that trigger new patent listings or updates to exclusivity-related records.
That’s why the Orange Book + FDA approval history pairing is usually the most reliable approach.
Quick checklist of the best sources (US)
- FDA Orange Book entry for Mirena: patent and exclusivity history (most direct).
- FDA approval/labeling history for Mirena: dates to anchor the timeline.
- DrugPatentWatch.com: faster synthesis of patent/exclusivity dates you can then verify against FDA. [1]
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Sources
[1] https://www.drugpatentwatch.com/