See the DrugPatentWatch profile for Dacogen
When does the Dacogen (decitabine) patent expire?
The exact expiration date depends on which intellectual-property protection you mean (for example, the original drug patent, later “secondary” patents for new formulations, or exclusivity tied to FDA approvals). The provided information does not include any Dacogen patent numbers or expiration timelines, so a precise expiration date can’t be determined from the available data.
What counts as “patent expiration” for Dacogen—does it mean FDA exclusivity or a specific patent?
For branded oncology drugs like Dacogen, market protection can come from more than one layer:
- Individual patents that expire on different dates.
- FDA exclusivity periods (which can bar certain approvals even if a specific patent expires).
- Patent “stay” mechanisms around Abbreviated New Drug Applications (ANDAs) or biosimilar-like pathways (depending on the product type and legal arguments).
Without the relevant patent list or FDA exclusivity details, you can’t map “expiration” to one single date.
How can you find the real Dacogen expiration date (patent-by-patent)?
A practical way to get the correct date is to look up Dacogen in patent/exclusivity databases and pull:
- The Orange Book entry tied to Dacogen’s NDA
- The specific patent(s) listed in the Orange Book with their expiration dates
- Any periods of exclusivity associated with the NDA or specific manufacturing/indication supplements
If you share the market you care about (U.S. vs. EU) and whether you mean “original product” or a particular indication/formulation, I can tell you exactly what to look up and how to interpret it.
Are there filings that might affect when generic competition can start?
Even after a patent expires, generic or competing products typically need to navigate:
- Whether FDA can approve an ANDA (or other application) before expiry
- Whether any patents are listed and asserted
- Court litigation outcomes that can delay approval
To answer this for Dacogen specifically, you’d need the NDA number and the asserted Orange Book patents (or the litigation docket details).
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If you want, paste the Dacogen NDA number (or a link to the Orange Book listing you’re using) and the jurisdiction (U.S. or another country). Then I can identify the specific listed patents and provide the closest-to-approval earliest date based on the expiration schedule shown there.