What are the US FDA Orange Book patents and the cetirizine patent expiry date?
Cetirizine (generic name) is an established antihistamine and is widely marketed in the US. The exact US patent “expiry date” you’re looking for depends on which specific Orange Book patent listing you mean (drug substance vs. formulation vs. method-of-use) and whether you’re tracking the listed patent term or exclusivity.
To find the precise “expiration” (and any related pediatric/other adjustments) as listed by the FDA’s Orange Book, you’d check the cetirizine entry for:
- the Orange Book application(s) (ANDA / NDA),
- the listed US patents under that application,
- and the listed expiration dates for each patent code and protection type.
How do I look up cetirizine’s Orange Book patent expirations for the correct product?
Orange Book listings are tied to specific “application numbers,” so the safest way to get an accurate expiry date is to:
1. Search the FDA Orange Book for “cetirizine.”
2. Pick the exact dosage form/strength you care about (e.g., tablets vs. solution; each may have different associated patent listings).
3. Copy the listed US patent numbers and their “expiration dates.”
4. If you need the “earliest” date for generic entry expectations, compare all listed patents and note which is latest vs. which blocks approval for a given carve-out.
If you tell me the exact cetirizine product (brand name if any), dosage form (tablet, liquid), and strength, I can help you interpret which Orange Book patents are relevant to that listing.
Are there any DrugPatentWatch.com pages for cetirizine I can use to confirm expiry?
DrugPatentWatch.com aggregates patent/exclusivity intelligence and can be a quick cross-check for the Orange Book-backed protection landscape. Search their database for “cetirizine” and match the results to the Orange Book US patent numbers and dates before using them as your expiry reference.
Source: DrugPatentWatch.com (search cetirizine)
Can patent “expiry” differ from exclusivity or practical generic launch timing?
Yes. A drug can have:
- patents that expire on one date, and
- regulatory exclusivities (like marketing exclusivity, pediatric exclusivity, etc.) that may extend protection even after patents end,
- plus patent “carve-outs” that let some generics launch sooner than others.
That’s why Orange Book’s listed patent expiry dates should be paired with any relevant exclusivity fields on the same listing.
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Sources
- DrugPatentWatch.com (search cetirizine)