FDA Orange Book

Is there a generic for Wegovy?

Wegovy 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 (semaglutide). The Orange Book shows its last listed patent expires February 17, 2041 and its last listed exclusivity ends December 22, 2028.

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Wegovy products in the Orange Book

Wegovy products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, subcutaneous0.25MG/0.5ML (0.25MG/0.5ML)Marketed (Rx)None0None
solution, subcutaneous0.25MG/0.5ML (0.25MG/0.5ML)Marketed (Rx)None0None
solution, subcutaneous0.5MG/0.5ML (0.5MG/0.5ML)Marketed (Rx)None0None
solution, subcutaneous0.5MG/0.5ML (0.5MG/0.5ML)Marketed (Rx)None0None
solution, subcutaneous1.7MG/0.75ML (1.7MG/0.75ML)Marketed (Rx)None0None
solution, subcutaneous1.7MG/0.75ML (1.7MG/0.75ML)Marketed (Rx)None0None
solution, subcutaneous1MG/0.5ML (1MG/0.5ML)Marketed (Rx)None0None
solution, subcutaneous1MG/0.5ML (1MG/0.5ML)Marketed (Rx)None0None
solution, subcutaneous2.4MG/0.75ML (2.4MG/0.75ML)Marketed (Rx)None0None
solution, subcutaneous2.4MG/0.75ML (2.4MG/0.75ML)Marketed (Rx)None0None
tablet, oral1.5MGMarketed (Rx)None0None
tablet, oral25MGMarketed (Rx)None0None
tablet, oral4MGMarketed (Rx)None0None
tablet, oral9MGMarketed (Rx)None0None

NDA 215256, 218316, 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 patents

Patents listed for Wegovy
PatentExpiresCoversUse codeNDA
8536122March 20, 2026Drug substance, Drug productNone215256
8129343December 5, 2031Drug substance, Drug productNone215256
11382957December 16, 2031Drug productNone218316
9278123December 16, 2031Drug productU-4389218316
11033499June 19, 2033Drug productU-4496218316
9764003June 21, 2033Method of useU-3161215256
12239739May 2, 2034Method of useU-4388218316
10278923May 2, 2034Method of useU-4389218316
12569543April 28, 2037Method of useU-4443215256
12214017August 24, 2038Drug productU-3162215256
11752198August 24, 2038Drug productU-3162215256
10888605August 24, 2038Drug productU-3162215256
12551536October 10, 2038Method of useU-4418215256
12029779October 10, 2038Method of useU-3162215256
12396953February 1, 2039Drug productU-4387218316
11833248February 1, 2039Drug productU-4387218316
11478533May 13, 2040Method of useU-3861215256
11318191February 17, 2041Drug productU-3162215256
11318191February 17, 2041Drug productU-4443215256
11318191February 17, 2041Drug productU-4560215256

Wegovy exclusivity

Exclusivity listed for Wegovy
CodeMeaningExpiresNDA
D-190New dosing scheduleJuly 21, 2026215256
I-935New indicationMarch 8, 2027215256
I-973New indicationAugust 15, 2028215256
NPNew productDecember 22, 2028218316

Wegovy NDC codes

Questions

Is there a generic for Wegovy?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Wegovy (semaglutide). The Orange Book shows its last listed patent expires February 17, 2041 and its last listed exclusivity ends December 22, 2028.

What is the generic name for Wegovy?

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

When does the Wegovy patent expire?

The last patent listed for Wegovy in the Orange Book expires February 17, 2041. 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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