Pembrolizumab orangebook patents?

If you’re asking about Pembrolizumab (Keytruda) in the FDA Orange Book, here’s how to find the current patent and exclusivity information:

- What the Orange Book is: It lists approved drug products and the patents and regulatory exclusivities that cover them in the U.S. It’s the official source for patent numbers and expiry dates related to a specific product.

- How to look it up:
- Go to the FDA Orange Book homepage: https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
- Use the search to look up “pembrolizumab” or “Keytruda.”
- Open the Pembrolizumab/Keytruda product page. There you’ll see sections for patents and for exclusivities (if applicable). It may show patent numbers, the type of patent (composition, method of use, formulation, etc.), and expiry dates.
- There may also be notes on pediatric exclusivity or other non-patent protections.

- What you’ll typically see:
- Patent numbers covering the antibody (composition of matter) and various methods of use.
- Additional patents on formulations, dosing regimens, or methods of manufacture.
- Non-patent exclusivities (e.g., pediatric, data exclusivity) in separate sections.

- Important caveats:
- Patent status can change with term extensions and litigation outcomes.
- Biologics like pembrolizumab also have regulatory data exclusivity (12-year data exclusivity under BPCIA in the U.S.), which is separate from patents.
- For legal or planning purposes, always cite the Orange Book page directly and consider confirming with counsel.

If you’d like, I can help you interpret a specific Orange Book page you provide (copy/paste the link or the patent list you see), or guide you step-by-step through a targeted search for Pembrolizumab. Do you want US-only information or also look for international patent data?