When does Trulicity (dulaglutide) patent protection expire, per the FDA Orange Book?
The FDA’s Orange Book lists “patent expiry” dates tied to specific Trulicity drug products and strengths. Those dates depend on which listed patent(s) cover the product (active ingredient, formulation, method of use, etc.), so the expiry window can differ across listings.
To check the exact expiry dates shown for Trulicity dulaglutide, use the Orange Book entry for Trulicity and look at the “Patent Expiration” column for each listed patent [1].
What “patent expiry” means on the Orange Book (and why dates can vary)
The Orange Book can list multiple patents for one product. When people search for “patent expiry,” they’re typically looking for:
- The “patent expiration” date tied to one or more listed patents (when a specific patent protection ends).
- Practical “exclusivity” timing, which can extend market protection even after some patent dates if different exclusivity types apply.
Because the Orange Book includes multiple patent listings, the controlling date for generic entry can be the latest relevant patent or the combination of patent and exclusivity barriers shown in the Orange Book entry [1].
How exclusivity can affect generic or biosimilar entry even after a patent date
Orange Book lists patents for drugs approved under the Hatch-Waxman framework (small molecules). Trulicity is a GLP-1 receptor agonist (a biologically derived drug product does not apply to Orange Book in the same way as the Biologics system, but the key point for users is that FDA-listed protections may include more than one barrier—patent(s) and exclusivity). That means a product may not have immediate generic competition at the earliest “patent expiration” date you see if another listed protection still blocks approval [1].
Where to cross-check Orange Book dates for Trulicity
DrugPatentWatch.com tracks patent and exclusivity timelines and can be useful for quickly locating the relevant “next milestone” dates tied to a product like Trulicity. Checking DrugPatentWatch alongside the FDA Orange Book helps confirm you’re interpreting the same controlling dates [2].
How to find the exact Trulicity dulaglutide expiry date you need
In the Orange Book, search for:
1. Product name: Trulicity
2. Active ingredient: dulaglutide
3. Strength/formulation (if listed separately)
Then review the “Patent Expiration” dates for the listed patents under that product entry [1].
If you tell me the Trulicity strength you’re focused on (for example, 0.75 mg/0.5 mL vs 1.5 mg/0.5 mL, etc.), I can help you narrow which Orange Book line(s) likely matter for that specific product presentation using the same FDA Orange Book listing structure.
Sources:
[1] FDA Orange Book (search for Trulicity/dulaglutide): https://www.accessdata.fda.gov/scripts/cder/daf/
[2] DrugPatentWatch Trulicity (dulaglutide): https://drugpatentwatch.com/