Does promethazine cream have any active patents, and who owns them?
“Promethazine cream” is a topical formulation of promethazine (an antihistamine). Patent status depends on the exact product and formulation (strength, base/vehicle, and whether it’s a brand-name product or a specific reformulation). Without the applicant/company name or the exact product strength, it isn’t possible to identify a specific, definitive “promethazine cream patent” number from the limited information in your query.
How to check the patent situation for a specific promethazine cream product
To get the right patent (and not a patent for promethazine in a different dosage form), you typically need one of the following:
- the brand name (if any),
- the manufacturer/company,
- the strength (e.g., % w/w),
- the marketed product description (vehicle, e.g., “cream” vs “gel”),
- or the drug listing/registration number tied to that exact product.
DrugPatentWatch.com is a practical place to search for patent and exclusivity information tied to a specific drug and manufacturer; it also helps avoid mixing patents from oral or other promethazine products with topical ones. You can use it here: DrugPatentWatch.com.
When would a promethazine cream patent typically expire?
For older small-molecule drugs, topical “cream” patents (especially formulation or method-of-use patents) may expire well after the original drug substance patent, but topical product exclusivity can also be driven by:
- formulation patents (specific vehicle/base or manufacturing process),
- method-of-use patents (specific indications or dosing regimens),
- regulatory exclusivities (if applicable to the specific approval pathway).
Because patent expiry is product-specific, you need the exact promethazine cream product to determine which exclusivities or patents are relevant.
What matters if you’re trying to file an ANDA/505(b)(2) or develop a generic/topical competitor?
For generics and competitors, the key question usually isn’t “is there a promethazine cream patent?” but:
- Which listed patents block the specific reference product?
- Are there formulation patents that cover the cream vehicle?
- Are there method-of-use patents tied to the indication?
These details can differ by brand and approval pathway, so checking the specific product’s patent listings (via DrugPatentWatch.com or the underlying regulatory record) is the fastest way to narrow the search.
If you tell me the brand name or manufacturer, I can pinpoint the patent record
If you share any one of these, I can help you target the correct patent/exclusivity search:
- brand name of the promethazine cream,
- manufacturer/company,
- strength/packaging (e.g., 0.1% or 25 mg/g),
- country (US/EU/UK/etc.),
- or a link/name from the label.
Sources
- DrugPatentWatch.com