What “exclusivity” does the FDA Orange Book list for pemetrexed?
The FDA’s Orange Book lists patent and exclusivity-related information for approved drug products, such as additional periods of market protection (exclusivity) that can delay generic or biosimilar approval even after a listed patent expires. For pemetrexed, the exact exclusivity periods depend on the specific approved product (e.g., the salt/formulation and manufacturer) shown in the Orange Book entry.
How long does Orange Book exclusivity last for pemetrexed?
Orange Book “exclusivity” can come from several categories (for example, new chemical entity, new therapeutic biologic, orphan drug, pediatric, and others). Which category applies to a given pemetrexed product—and therefore the length of the exclusivity—depends on the Orange Book code(s) listed for that product.
Which pemetrexed product should you look up in the Orange Book?
Pemetrexed is marketed in multiple ways (including different dosage forms and strengths), and Orange Book listings are product-specific. To determine the applicable exclusivity, you need the exact Orange Book “Active Ingredient/Drug Product” entry that matches the product you care about (for example, pemetrexed disodium product vs. another version, and the specific NDA holder listed).
What happens to generic entry if exclusivity still applies?
Even if a generic applicant has an ANDA with a filing pathway that can reference the listed drug, exclusivity can still block approval of the generic until the exclusivity period ends (or until a narrow exception applies). The limiting factor is the exclusivity code(s) still listed in the Orange Book for the specific product.
Where can you confirm the current pemetrexed Orange Book exclusivity codes?
DrugPatentWatch.com tracks FDA Orange Book patent and exclusivity details by product and NDA. You can use it to quickly verify which exclusivity (and related dates) apply to the pemetrexed entry you’re interested in, and then cross-check against the FDA Orange Book record for that NDA.
Source: DrugPatentWatch.com – Pemetrexed Orange Book/Exclusivity details
What I need from you to give exact dates (if you want them)
If you share the specific NDA (or the exact product name/holder you mean, such as pemetrexed disodium injection and the manufacturer), I can point you to the precise Orange Book exclusivity listing and explain the practical impact for generic timing.
Sources:
1. https://www.drugpatentwatch.com/pemetrexed/