Is There a Generic for Rybelsus?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Rybelsus (semaglutide). The Orange Book shows its last listed patent expires May 2, 2034 and its last listed exclusivity ends October 17, 2028.

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Rybelsus products in the Orange Book

Rybelsus products and approved generics
Form and route	Strength	Brand status	Brand TE	Generic TE codes
tablet, oral	14MG	Marketed (Rx)	None	None
tablet, oral	3MG	Marketed (Rx)	None	None
tablet, oral	7MG	Marketed (Rx)	None	None

NDA 213051, 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.

Rybelsus patents

Patents listed for Rybelsus
Patent	Expires	Covers	Use code	NDA
8536122	March 20, 2026	Drug substance, Drug product	U-2628	213051
8129343	December 5, 2031	Drug substance, Drug product	U-2628	213051
9278123	December 16, 2031	Drug product	U-2628	213051
10960052	December 16, 2031	Drug product	None	213051
10086047	December 16, 2031	Drug product	None	213051
11382957	December 16, 2031	Drug product	None	213051
11759503	March 15, 2033	Drug product	None	213051
10933120	March 15, 2033	Drug product	None	213051
11759501	March 15, 2033	Drug product	None	213051
11759502	March 15, 2033	Drug product	None	213051
12594326	March 15, 2033	Drug product	None	213051
11033499	June 19, 2033	Drug product	U-2628	213051
10278923	May 2, 2034	Method of use	U-2628	213051
12514822	May 2, 2034	Method of use	U-2628	213051
12239739	May 2, 2034	Drug substance, Drug product	U-2628	213051

Rybelsus exclusivity

Exclusivity listed for Rybelsus
Code	Meaning	Expires	NDA
I-976	New indication	October 17, 2028	213051

Rybelsus NDC codes

Questions

Is there a generic for Rybelsus?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Rybelsus (semaglutide). The Orange Book shows its last listed patent expires May 2, 2034 and its last listed exclusivity ends October 17, 2028.

What is the generic name for Rybelsus?

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

When does the Rybelsus patent expire?

The last patent listed for Rybelsus in the Orange Book expires May 2, 2034. 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.