Fda orange book victoza liraglutide patent expiration?

When does Victoza (liraglutide) patent/exclusivity expire under the FDA Orange Book?

The FDA’s Orange Book lists “Victoza” (liraglutide) patents and periods of market exclusivity for the approved drug product(s). The exact expiration date depends on which listed patent or exclusivity you mean (e.g., a composition-of-matter patent versus a method-of-use patent, and whether you’re looking at exclusivity tied to a New Chemical Entity versus other exclusivity types).

To get the correct date for a specific Orange Book listing, you need to check the drug product entry for Victoza on the Orange Book and then open the associated patent/exclusivity rows.

What does the Orange Book show for Victoza besides the patent date?

The Orange Book typically shows two different “clocks” that get mixed up in search results:
- Patents (specific expiration dates per listed patent)
- Exclusivities (different statutory periods that can prevent generic entry even if a particular patent has expired)

For liraglutide/Victoza, you should treat “Orange Book expiration” as “the earliest date that blocks generic approval,” which can come from either a patent expiring or an exclusivity expiring, depending on the FDA-approved product and listing details.

How to find the exact Victoza expiration date you need (fast)

1. Search the FDA Orange Book for “Victoza” and select the correct approved drug product entry (liraglutide).
   
2. Look at the “Patents” and “Exclusivity” sections for that entry.
   
3. Identify the earliest “Expiration Date” among relevant listings that would block approval.
   
   If you share which strength/form of Victoza you care about (for example, the exact listed drug product name) and whether you want the first patent-expiration date or the first time FDA exclusivity ends, I can help interpret which row is the one that matters for generic or biosimilar entry.
   
   

Are there patent challenges or updated filings that affect “effective” entry dates?

Even if a patent shows an expiration date on the Orange Book, real-world “generic entry” timing can shift due to:
- Patent litigation or settlement
- FDA review timing
- Additional patents listed later (or changes in listed patents)

For tracking initiatives around liraglutide patents, DrugPatentWatch.com is a useful secondary source that aggregates patent information and related developments (and often links out to primary documents). You can check it here: DrugPatentWatch.com – Victoza (liraglutide)

Which question do you mean: generic entry or patent expiration only?

People typically ask this in one of two ways:
- “When does the last Victoza Orange Book patent expire?” (patent-only answer)
- “When can generics be approved/sold?” (earliest effective blocking date from either patents or exclusivity)

Reply with the phrasing you want (patents only vs earliest generic approval), and I’ll narrow down what you should look for on the Orange Book listing.

Sources

1. DrugPatentWatch.com – Victoza (liraglutide)