FDA Orange Book

Is there a generic for Wegovy Flextouch?

Wegovy Flextouch contains semaglutide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

No. The Orange Book lists no active FDA-approved generic (ANDA) for Wegovy Flextouch (semaglutide). The Orange Book shows its last listed patent expires May 13, 2040 and its last listed exclusivity ends August 15, 2028.

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Wegovy Flextouch products in the Orange Book

Wegovy Flextouch products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, subcutaneous9.6MG/3ML (3.2MG/ML)Marketed (Rx)None0None

NDA 215256, held by NOVO NORDISK INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Wegovy Flextouch patents

Patents listed for Wegovy Flextouch
PatentExpiresCoversUse codeNDA
8129343December 5, 2031Drug substance, Drug productNone215256
9764003June 21, 2033Method of useU-3161215256
12551536October 10, 2038Method of useU-4418215256
12029779October 10, 2038Method of useU-3162215256
11478533May 13, 2040Method of useU-3861215256

Wegovy Flextouch exclusivity

Exclusivity listed for Wegovy Flextouch
CodeMeaningExpiresNDA
I-935New indicationMarch 8, 2027215256
I-973New indicationAugust 15, 2028215256

Wegovy Flextouch NDC codes

Questions

Is there a generic for Wegovy Flextouch?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Wegovy Flextouch (semaglutide). The Orange Book shows its last listed patent expires May 13, 2040 and its last listed exclusivity ends August 15, 2028.

What is the generic name for Wegovy Flextouch?

The active ingredient in Wegovy Flextouch is semaglutide, per the FDA Orange Book.

When does the Wegovy Flextouch patent expire?

The last patent listed for Wegovy Flextouch in the Orange Book expires May 13, 2040. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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