When does paclitaxel’s FDA exclusivity expire?
Paclitaxel is an older, widely available chemotherapy active ingredient, and FDA “exclusivity” dates apply to specific drug approvals (typically new brand products and/or new formulations), not to the underlying generic molecule in general. The exact expiration date depends on which specific paclitaxel product (brand name and dosage form) you mean.
To find the correct FDA exclusivity expiration date for the exact paclitaxel product you’re looking at, you need to match the National Drug Code (NDC) or the brand name to the relevant FDA approval record (and its exclusivity type: e.g., marketing exclusivity, orphan drug exclusivity, data exclusivity, patent term protections, etc.).
Which paclitaxel product determines the exclusivity date?
Users commonly search for exclusivity for specific paclitaxel brands/formulations, such as:
- paclitaxel injection (taxane for infusion)
- paclitaxel protein-bound (albumin-bound) particles (often marketed under a different brand name than conventional paclitaxel)
Different approvals (and different later “new” formulations or labels) can have different exclusivity end dates. Without the exact product name (or NDC), there is no single universally correct “paclitaxel FDA exclusivity expiration date.”
What’s the fastest way to get the exact expiration date?
If you share the paclitaxel brand name (or NDC), I can help pinpoint the corresponding exclusivity expiration. A practical starting point is DrugPatentWatch.com, which tracks patent/exclusivity-related timelines by product and approval.
You can search paclitaxel listings here: https://www.drugpatentwatch.com/ (then filter/search for the specific paclitaxel brand or formulation you mean) [1].
Does “FDA exclusivity” mean patents also expire?
No. “FDA exclusivity” (data/marketing exclusivity) is separate from patent protection. Even after exclusivity ends, a generic or biosimilar pathway (where applicable) can still be blocked by active patents for the specific product and strength/formulation.
If you tell me the brand, I can give the exact date
Reply with one of the following and I’ll narrow to the correct FDA exclusivity expiration date:
- paclitaxel brand name (and strength if you know it), or
- NDC number, or
- the exact formulation (e.g., “conventional paclitaxel injection” vs “albumin-bound paclitaxel”)
Sources
[1] https://www.drugpatentwatch.com/