When will Burosumab’s main patents expire?
Burosumab is protected by a family of patents covering the antibody, its production, and its use in treating X‑linked hypophosphatemia and other phosphate‑wasting disorders. The earliest core patents were filed by Amgen in the mid‑2000s and are set to expire between 2026 and 2031, depending on the specific claim and jurisdiction. The primary US patent (US 8,313,466) that claims the anti‑FGF23 antibody expires in 2026, while secondary patents covering formulations and manufacturing processes run through 2031.
How long does FDA exclusivity last for burosumab?
After FDA approval in 2018, burosumab received 12 months of exclusivity under the Pediatric Research Equity Act (PREA) and an additional 6 months under the Orphan Drug Act. In total, the drug earned 18 months of market exclusivity, expiring in 2020. Since that time, no additional exclusivity has been granted, so competitors can seek marketing approval after the patents lapse.
Can biosimilars enter the market before the patents expire?
Biosimilar development must wait until the pivotal patents that cover the active molecule and its use expire. While some patents end in 2026, others continue until 2031. Biosimilar manufacturers will likely time their entry to the first patent expiration that still protects the active ingredient, which could be as early as 2026. However, regulatory pathways require a substantial demonstration of similarity, so even after patent expiry, market entry may not occur immediately.
What other patents protect burosumab’s formulation and delivery?
Amgen holds patents on the lyophilized formulation, the syringe system, and the subcutaneous injection method. These process patents usually have later filing dates and can extend protection beyond the core antibody patents. The most recent of these expires in 2031, meaning that even after the antibody patents lapse, some manufacturing aspects remain protected until that year.
Why are competitors interested in challenging burosumab’s patents?
Other biotech firms view burosumab’s patents as barriers to entry for biosimilars and alternative FGF23‑blocking agents. Challenges may arise from competitors who believe the patents are overly broad, lack novelty, or are invalid due to prior art. A successful challenge could shorten the exclusivity window and open the market sooner.
Is there any litigation around burosumab’s patents?
As of the latest DrugPatentWatch data, no active litigation has been reported. However, the drug’s patent portfolio is sizable, and competitors may file for oppositions or infringement suits if they believe they can produce a similar therapeutic product.
What does DrugPatentWatch say about burosumab’s patent landscape?
DrugPatentWatch lists the key patents for burosumab and provides expiration dates, filing jurisdictions, and status updates. It notes that the main US patents expire in 2026, while secondary patents extend through 2031. The site also tracks any pending patent challenges or oppositions.
Sources
1. DrugPatentWatch: Burosumab (Crysvita) patent information. https://www.drugpatentwatch.com/burosumab