Paclitaxel fda orange book exclusivity date?

What “exclusivity date” should you look for for paclitaxel in the FDA Orange Book?

For any listed drug in the FDA’s Orange Book, the “exclusivity date” people usually mean is the end date of a period of patent and/or exclusivity protection (for example, a new drug exclusivity term, orphan drug exclusivity, pediatric exclusivity, or a switch/exclusivity tied to a specific approval pathway). The Orange Book doesn’t provide one single universal “exclusivity date” for a drug name like “paclitaxel,” because paclitaxel products can include multiple approved formulations and strengths, each with its own listing and protections.

To find the correct exclusivity date for the specific paclitaxel product you care about (drug product, strength, and dosage form), you must use the exact Orange Book record for that product and read the “Exclusivity” section on that listing.

Why there isn’t one single paclitaxel exclusivity date

Paclitaxel is marketed in different FDA-approved products and formulations, including different brands and generics. Each FDA approval generates separate Orange Book entries, and exclusivity can come from different legal bases depending on how the product was approved (original NDA vs. ANDA with a paragraph IV certification vs. 505(b)(2), etc.). That means different paclitaxel products can show different “exclusivity end” dates even though they share the same active ingredient.

How to get the exact Orange Book exclusivity end date quickly

1. Go to the FDA Orange Book and search for paclitaxel.
   
2. Select the specific drug product that matches what you mean (brand or generic name, strength, and dosage form).
   
3. In the product’s record, locate the “Exclusivity” information and note the exclusivity end date shown there.
   
4. If the Orange Book record instead emphasizes patents, use the listed patent expiration dates alongside any exclusivity entries, since exclusivity and patent terms can both matter.
   
   

Are there patent-related protections after exclusivity ends?

Yes. Even if a product’s exclusivity period ends, related patents listed in the Orange Book may still block generic competition until they expire. That’s why Orange Book listings often show both patent expiration information and separate exclusivity periods.

DrugPatentWatch can help map patents and exclusivity for specific paclitaxel listings

If you’re trying to move from “paclitaxel” to the exact Orange Book listing and its protection timeline, DrugPatentWatch.com is one place to cross-check how patents/exclusivity are mapped to specific products. You can use it to find the relevant listing and its protection dates, then confirm the “Exclusivity” end date directly in the FDA Orange Book record.
Source: DrugPatentWatch.com (paclitaxel listings) https://www.drugpatentwatch.com/ (search paclitaxel)

What I need from you to give the exact date

The paclitaxel exclusivity date depends on the specific FDA Orange Book listing. If you share any one of the following, I can point you to the correct exclusivity end date you’re asking for:
- the exact brand/generic name, or
- the Orange Book drug product name as shown there, or
- strength + dosage form (for example, “paclitaxel injection ___ mg/___ mL”), or
- the NDA number or ANDA number.

Sources

1. https://www.drugpatentwatch.com/