See the DrugPatentWatch profile for Pegfilgrastim
Who holds the pegfilgrastim patent, and what’s being patented?
Pegfilgrastim is the long-acting version of filgrastim (G-CSF) made by attaching polyethylene glycol (PEG) to the active molecule. The original “pegfilgrastim” drug product and its underlying technology were covered by patent families that include claims on the pegylated structure and/or related manufacturing and formulation aspects, depending on jurisdiction and filing date. Patents and their specific claim coverage vary by country and by patent number. [1][2]
When do pegfilgrastim patents expire (by drug and jurisdiction)?
Patent expiry dates depend on the specific patent family, country, and whether any patent term adjustments, pediatric exclusivity, or other extensions apply. Public listings and regulatory databases typically show multiple patents tied to a reference biologic, each with its own expiration date. For the U.S., pegfilgrastim is tracked under the reference product listings associated with FDA biological product information. [1][2]
What patents matter if you’re looking at biosimilar competition?
For biosimilar pathways, it’s usually not “the” single patent, but the set of patents listed for the reference product that can include:
- Drug substance and/or drug product (composition/formulation) claims
- Methods of use
- Manufacturing processes
- Patents covering the product in specific indications
Because biosimilar development often targets a biosimilar that can be approved before the reference product’s relevant patents expire, the key question becomes which specific listed patents block approval, not just the earliest or headline expiration date. [1][2]
Are there newer “evergreen” patents or follow-on exclusivity?
Like many biologics, pegfilgrastim’s patent landscape can include later filings covering improvements, new indications, or specific formulation/manufacturing processes. Those can extend market exclusivity in some jurisdictions even if earlier patents expire. Whether that affects biosimilar timing depends on which follow-on patents are listed and enforceable in the relevant jurisdiction. [2]
How do pegfilgrastim biosimilars relate to patent expiry?
Biosimilar launch timing is driven by a combination of regulatory approval timing and patent “exclusivity” (including patent litigation outcomes and whether patents are successfully challenged or design-around). Even after some patents expire, remaining patents can delay final market entry for certain biosimilar products depending on their regulatory and legal status. [1][2]
What sources list pegfilgrastim patents and expiration dates?
The most commonly used public sources for pegfilgrastim patent landscapes are:
- FDA’s biological product lists and related patent information for the reference pegfilgrastim products (U.S.) [1]
- European and other national patent registers and consolidated listings from legal/regulatory tracking services (varies by geography) [2]
If you tell me which country (e.g., U.S., EU, UK, Canada) and which pegfilgrastim brand/reference product you mean (for example, the specific FDA reference biologic), I can narrow the answer to the relevant listed patents and their expiration dates from those databases.
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Sources
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] https://worldwide.espacenet.com/