Is There a Generic for Tarpeyo?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Tarpeyo (budesonide). The Orange Book shows its last listed patent expires January 23, 2043 and its last listed exclusivity ends December 20, 2030.

Run it in Rivvi

Map Tarpeyo and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Tarpeyo products in the Orange Book

Tarpeyo products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, delayed release, oral	4MG	Marketed (Rx)	None	0	None

NDA 215935, held by CALLIDITAS THERAPEUTICS AB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Tarpeyo patents

Patents listed for Tarpeyo
Patent	Expires	Covers	Use code	NDA
8491932	May 7, 2029	Drug product	U-3269	215935
8491932	May 7, 2029	Drug product	U-3781	215935
11896719	January 23, 2043	Method of use	U-3810	215935
12171882	January 23, 2043	Method of use	U-4085	215935
12171882	January 23, 2043	Method of use	U-4086	215935
12311057	January 23, 2043	Drug product	U-4085	215935
12311057	January 23, 2043	Drug product	U-4086	215935
12311057	January 23, 2043	Drug product	U-4204	215935
12171883	January 23, 2043	Drug product	None	215935

Tarpeyo exclusivity

Exclusivity listed for Tarpeyo
Code	Meaning	Expires	NDA
ODE-389	Orphan drug exclusivity	December 15, 2028	215935
ODE-464	Orphan drug exclusivity	December 20, 2030	215935

Tarpeyo NDC codes

81749-004

Questions

Is there a generic for Tarpeyo?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Tarpeyo (budesonide). The Orange Book shows its last listed patent expires January 23, 2043 and its last listed exclusivity ends December 20, 2030.

What is the generic name for Tarpeyo?

The active ingredient in Tarpeyo is budesonide, per the FDA Orange Book.

When does the Tarpeyo patent expire?

The last patent listed for Tarpeyo in the Orange Book expires January 23, 2043. 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.