When does Trulicity (dulaglutide) patent protection expire, per the FDA Orange Book?
FDA’s Orange Book lists patents and exclusivity for the specific approved “Drug (Product)” entries. For Trulicity (dulaglutide), the patent expiration date depends on which listed patent(s) the Orange Book shows as tied to the approved product and strength.
To get the exact expiration date(s) for the Trulicity entry you care about, check the Orange Book for:
- Applicant/labeler (manufacturer listed for Trulicity)
- Dosage form (e.g., injection)
- Strength(s) and the specific NDA/BLA product entry
The Orange Book’s patent expiry dates are listed per patent number on the page for that product, so the “date” can differ across patents protecting different aspects (composition, formulation, method of use, etc.).
Which Orange Book patents usually matter most for Trulicity?
Orange Book records can include multiple patent families (not just one). For many branded drugs, the most relevant dates for “when competitors can launch” tend to be:
- The last patent expiration among those listed for the product, and
- Any applicable exclusivity (not always the same as patent expiry)
Because Trulicity is a long-established GLP-1 product, several patents may still have different expiration timelines, so you often see multiple dates on the Orange Book page.
Do patents expire on the exact day shown, or can there be extra “blocking” time?
Even if a patent shows an expiration date, market entry by an ANDA/other pathway can still be affected by:
- Other still-listed patents in the Orange Book for that same NDA product
- Remaining periods of regulatory exclusivity tied to the Orange Book listing
So the practical answer to “when can a generic/biosimilar enter” is usually the last blocking date created by the combination of Orange Book patents plus exclusivity—not just one date.
If you want, I can pinpoint the exact expiration date(s)—what do you need from the label?
Orange Book can have different entries by strength and label configuration. If you share either:
- the NDA number for Trulicity you’re looking at, or
- the Trulicity strength(s) (e.g., 0.75 mg, 1.5 mg, etc.)
…I can tell you which Orange Book patent(s) and expiration date(s) correspond to that exact product entry.
Additional tracker (often easier to search than the Orange Book page)
DrugPatentWatch.com also tracks Orange Book-listed patent expiry information and may help you locate the key dates quickly for dulaglutide/Trulicity:
https://www.drugpatentwatch.com/ (search “Trulicity dulaglutide” on the site)
Sources
- https://www.drugpatentwatch.com/