FDA Orange Book

Generic for Myrbetriq

Myrbetriq contains mirabegron. 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

Yes. The generic name for Myrbetriq is mirabegron. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Myrbetriq products in the Orange Book

Myrbetriq products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, extended release, oral	25MG	Marketed (Rx)	AB	7	AB
tablet, extended release, oral	50MG	Marketed (Rx)	AB	7	AB

NDA 202611, held by ASTELLAS PHARMA GLOBAL DEVELOPMENT INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic mirabegron

Approved generic versions of Myrbetriq
Company	ANDA	TE code	Approved	Strengths
LUPIN LTD	209485	AB (A-rated, therapeutically equivalent)	September 28, 2022	25MG, 50MG
ZYDUS PHARMACEUTICALS USA INC	209488	AB (A-rated, therapeutically equivalent)	September 29, 2022	25MG, 50MG
ALKEM LABORATORIES LTD	215948	AB (A-rated, therapeutically equivalent)	February 12, 2024	25MG, 50MG
QILU PHARMACEUTICAL CO LTD	217989	AB (A-rated, therapeutically equivalent)	June 30, 2025	25MG, 50MG
MSN LABORATORIES PRIVATE LTD	218543	AB (A-rated, therapeutically equivalent)	November 4, 2025	25MG, 50MG
DEVA HOLDING AS	219941	AB (A-rated, therapeutically equivalent)	May 1, 2026	25MG, 50MG
CREEKWOOD PHARMACEUTICALS LLC	219599	AB (A-rated, therapeutically equivalent)	October 7, 2026	25MG, 50MG

Myrbetriq patents

Patents listed for Myrbetriq
Patent	Expires	Covers	Use code	NDA
8772315	October 30, 2028	Method of use	U-2300	202611
8772315*PED	April 30, 2029	Method of use	None	202611
10842780	September 28, 2029	Drug product	U-3670	202611
12097189	September 28, 2029	Method of use	U-2996	202611
12097189	September 28, 2029	Method of use	U-3670	202611
11707451	September 28, 2029	Method of use	U-2996	202611
11707451	September 28, 2029	Method of use	U-3670	202611
10842780	September 28, 2029	Drug product	U-2996	202611
12059409	September 28, 2029	Drug product	None	202611
11707451*PED	March 28, 2030	Method of use	None	202611
12097189*PED	March 28, 2030	Method of use	None	202611
10842780*PED	March 28, 2030	Method of use	None	202611
12059409*PED	March 28, 2030	Method of use	None	202611

Myrbetriq NDC codes

Questions

Is there a generic for Myrbetriq?

Yes. The generic name for Myrbetriq is mirabegron. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Myrbetriq?

The active ingredient in Myrbetriq is mirabegron, per the FDA Orange Book.

When does the Myrbetriq patent expire?

The last patent listed for Myrbetriq in the Orange Book expires March 28, 2030. 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.