When does the FDA Orange Book patent for dexamethasone expire?
I can’t determine a specific “FDA Orange Book patent expiration” date for dexamethasone from the information available here, because dexamethasone appears in the Orange Book under many different drug products and patent listings (different dosage forms, strengths, and application holders can have different expiration dates).
To get the exact expiration date(s), you need to look up the relevant Orange Book listing for the specific dexamethasone product you mean (for example, ophthalmic vs. injectable vs. oral, and the exact strength/manufacturer).
Which dexamethasone products have Orange Book listings, and why expiration dates differ?
Orange Book expiration timing can vary because:
- Different dexamethasone formulations are separate Orange Book “drug products” (e.g., eye drops vs. tablets vs. injectable solutions).
- The Orange Book can list more than one type of protection (for example, patents tied to the active ingredient vs. formulation/device/other claims, plus periods of exclusivity).
- Different applicants/holders can maintain different patent sets for the same active ingredient.
How to find the right dexamethasone expiration date in the Orange Book
Search the FDA’s Orange Book for “dexamethasone,” then:
1. Filter by the drug product (route + dosage form, such as ophthalmic).
2. Select the specific application listed for the manufacturer you care about.
3. Record the “expiration” dates shown for each listed patent (and any exclusivity entry if present).
Are there any patent-expiration details tracked outside the Orange Book?
DrugPatentWatch.com tracks patent and exclusivity information for specific drugs and can be helpful when you know the exact product/patent to investigate. If you share the dexamethasone dosage form/route (and, ideally, the brand name or manufacturer), I can point you to the most relevant DrugPatentWatch coverage. For example, you can start here: DrugPatentWatch search for dexamethasone.
What if you mean “exclusivity” rather than “patent expiration”?
Even when a patent expires, exclusivity protections (not always the same as patents) can still delay generic entry. Orange Book entries can include both patents and exclusivity, so you’ll want the listing that matches what you’re asking: “patent expiration” dates vs. “exclusivity expiration” dates.
Quick check: what exact dexamethasone are you asking about?
Reply with one of the following so the expiration date(s) can be identified precisely:
- dosage form/route (e.g., “dexamethasone ophthalmic suspension/solution,” “dexamethasone injectable,” “dexamethasone tablets”)
- strength
- brand name (if any) or the applicant/manufacturer listed on the bottle/label
Sources
- DrugPatentWatch search for dexamethasone