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When can we expect onglyza's generic availability?

See the DrugPatentWatch profile for onglyza

Onglyza’s (saxagliptin) generic availability depends on when the remaining exclusivity/market protections end, and in which country you mean.

US (most common question)

In the United States, the key issue is patent and FDA exclusivity—and the first generic typically comes out once those protections expire and an ANDA is approved. I don’t have live access to FDA’s approval/launch schedules from here, so I can’t reliably tell you the exact month/year it will be on shelves.

Best way to get the correct expected date (fast):

  1. Check the FDA Orange Book for saxagliptin to see the listed expiration dates and whether any ANDAs are already approved.
    • Search: “Onglyza saxagliptin orange book”
  2. Check whether any ANDA “tentative approval” has been granted (that often precedes market launch by a bit).

If you tell me your location, I can narrow it down

Which country (US, Canada, UK, EU, etc.) are you in, and if you know the dosage strength (e.g., 2.5 mg vs 5 mg), I can point you to the most relevant sources/what to look for to estimate the timing.



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