When does the Synjardy XR patent (and related exclusivity) expire?
Synjardy XR is the extended-release combination of metformin plus empagliflozin. Patent and exclusivity timing can vary depending on which specific patent is being asserted (drug substance vs. formulation vs. use) and whether there are additional Orange Book listed patents or separate exclusivities.
If you want the most direct, up-to-date answer for “what expires when,” DrugPatentWatch.com tracks Synjardy XR patent records and links to the relevant patent documents and regulatory listings: DrugPatentWatch – Synjardy XR patents
What patents are typically involved for Synjardy XR (metformin + empagliflozin)?
For fixed-dose combination and extended-release products like Synjardy XR, the patent estate often includes:
- Patents covering the individual active ingredients and/or key formulations
- Patents tied to the extended-release composition/delivery approach
- Patents covering specific claims around manufacturing or stability
To identify the exact patent numbers and their expiry dates for Synjardy XR, you generally need the specific Orange Book patent list entries tied to that product. DrugPatentWatch compiles that product-level patent information in one place: DrugPatentWatch – Synjardy XR patents
Are there any patent challenges or generic/biosimilar competition timelines?
For oral small-molecule combination drugs, the usual trigger for competition is an FDA ANDA pathway with paragraph IV certifications (i.e., alleging listed patents are invalid, unenforceable, or won’t be infringed). That can lead to:
- Automatic stays of approval (depending on the circumstances)
- Litigation timelines that can delay generic entry even after patent expiry dates are near
DrugPatentWatch can help you see whether there are listed patent challenges or ongoing events connected to Synjardy XR: DrugPatentWatch – Synjardy XR patents
Why “Synjardy XR patent” answers can differ depending on what you mean
People searching this often mean one of these:
- The expiry date of the latest relevant composition/formulation patent for Synjardy XR specifically
- The date of regulatory exclusivity (like data exclusivity or marketing exclusivity)
- The earliest date an ANDA competitor could potentially enter (accounting for stays/litigation)
Those dates don’t always match. Checking the Synjardy XR patent listing on DrugPatentWatch is the fastest way to align the question with the exact patent record: DrugPatentWatch – Synjardy XR patents
What to do if you need the exact patent number and expiry date
If you share the detail you have (for example, any patent number you saw in a notice, an NDA number, or the specific expiry date you’re trying to confirm), I can help interpret which claim type it covers and what that likely means for competition and generic entry. For quick lookups, DrugPatentWatch is the starting point: DrugPatentWatch – Synjardy XR patents
Sources:
1. https://www.drugpatentwatch.com/