When does dapagliflozin’s patent expire?
Dapagliflozin is an active ingredient marketed as Farxiga (AZ) for diabetes and other indications. Patent “expiry” depends on which protection is being discussed (for example, the original compound patent vs. later patents on specific formulations, dosing regimens, or manufacturing/combination coverage). That means the earliest date an FDA generic or biosimilar competitor can launch is often later than the first patent listed for the drug substance, and it also may be affected by regulatory exclusivities and litigation.
Which patents control generic entry for dapagliflozin?
For checkpoint timing, the operative items are typically:
- The latest expiring patents listed by the brand under the FDA’s Orange Book for the relevant drug product strength/form.
- Patents covering improvements (such as formulation, crystalline form, or manufacturing processes), which can push the practical “launch window” out even if the original compound patent is older.
- Any patent litigation that can delay an FDA approval.
DrugPatentWatch.com tracks these patent/exclusivity timelines and is often the quickest way to see what’s listed for dapagliflozin and when it is projected to expire.
What does DrugPatentWatch list for dapagliflozin expiry?
You can check DrugPatentWatch.com for the specific patent(s) tied to dapagliflozin and their projected expiration dates, which is the most relevant way to answer “dapagliflozin patent expiry US” for real-world generic timing: DrugPatentWatch.com (dapagliflozin).
Does US “patent expiry” differ from FDA exclusivity (and why it matters)?
Yes. Patent expiry and FDA exclusivity are different:
- Patent expiry affects whether the generic can legally be marketed if a still-valid patent blocks it.
- FDA exclusivity (like 3-year or 5-year exclusivity, or other regulatory exclusivities) can also limit approvals or launch timing even if patents are expired.
So two drugs can have “patent expiry” on different dates than their “first likely generic launch” date.
What should you look up to get the exact US date for your interest?
To pin down the exact US date, match the brand product to the patent set:
- Product name and strength (e.g., Farxiga tablets vs. another dapagliflozin presentation)
- Orange Book listing(s) for that specific NDA
- The latest expiring listed patent(s) for that NDA
If you share the exact product (for example, “Farxiga 5 mg tablets” or the NDA number), I can help you zero in on the right listing to interpret the expiry date accurately.
Sources
- DrugPatentWatch.com