Is there a generic for Mirabegron?

Yes. The FDA Orange Book lists 10 approved generic (ANDA) applications for Mirabegron, referencing the brand MYRBETRIQ GRANULES. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Mirabegron?

MYRBETRIQ GRANULES (NDA 213801, APGDI) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Mirabegron?

The Orange Book lists 12 patents against Mirabegron products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Mirabegron are approved?

Mirabegron is approved in the following dosage forms: for suspension, extended release, tablet, extended release.

FDA Orange Book · active-ingredient family

Mirabegron

Mirabegron: 2 brands, 10 generics; first approved Jun 28, 2012; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 10 ANDA applications approved.

Earliest patent expiry Oct 30, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 30, 2028

in 2 yr 1 mo

Brand (NDA) products

Originator applications

MYRBETRIQ GRANULESRLDRS
APGDINDA 2138012021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8MG/ML FOR SUSPENSION, EXTENDED RELEASE ORAL Rx AB
MYRBETRIQRLDRS
APGDINDA 20261120122 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, EXTENDED RELEASE ORAL Rx AB
50MG TABLET, EXTENDED RELEASE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG/ML	FOR SUSPENSION, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
50MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Generic (ANDA) products (10)

Abbreviated applications

MIRABEGRON
DEVA HOLDING ASANDA 21994120262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, EXTENDED RELEASE ORAL Rx AB
50MG TABLET, EXTENDED RELEASE ORAL Rx AB
MIRABEGRON
ALKEM LABS LTDANDA 2193232026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8MG/ML FOR SUSPENSION, EXTENDED RELEASE ORAL Rx AB
MIRABEGRON
MSNANDA 21854320252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, EXTENDED RELEASE ORAL Rx AB
50MG TABLET, EXTENDED RELEASE ORAL Rx AB
MIRABEGRON
QILUANDA 21798920252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, EXTENDED RELEASE ORAL Rx AB
50MG TABLET, EXTENDED RELEASE ORAL Rx AB
MIRABEGRON
SAWAI USAANDA 2170612025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET, EXTENDED RELEASE ORAL Discontinued —
MIRABEGRON
APOTEXANDA 20943420252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, EXTENDED RELEASE ORAL Discontinued —
50MG TABLET, EXTENDED RELEASE ORAL Discontinued —
MIRABEGRON
ALKEM LABS LTDANDA 21594820242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, EXTENDED RELEASE ORAL Rx AB
50MG TABLET, EXTENDED RELEASE ORAL Rx AB
MIRABEGRON
ZYDUS PHARMSANDA 20948820222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, EXTENDED RELEASE ORAL Rx AB
50MG TABLET, EXTENDED RELEASE ORAL Rx AB
MIRABEGRON
LUPINANDA 20948520222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, EXTENDED RELEASE ORAL Rx AB
50MG TABLET, EXTENDED RELEASE ORAL Rx AB
MIRABEGRON
SAWAI USAANDA 2094462019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, EXTENDED RELEASE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
50MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG/ML	FOR SUSPENSION, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
50MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
50MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
50MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
50MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
50MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
50MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8772315	Oct 30, 2028	in 2 yr 1 mo	U-2300
8772315*PED	Apr 30, 2029	in 2 yr 7 mo
10842780	Sep 28, 2029	in 3 yr	ProductU-3670
12097189	Sep 28, 2029	in 3 yr	U-2996
11707451	Sep 28, 2029	in 3 yr	U-2996
12059409	Sep 28, 2029	in 3 yr	Product
11707451*PED	Mar 28, 2030	in 3 yr 6 mo
12097189*PED	Mar 28, 2030	in 3 yr 6 mo
10842780*PED	Mar 28, 2030	in 3 yr 6 mo
12059409*PED	Mar 28, 2030	in 3 yr 6 mo
10058536	Mar 31, 2036	in 9 yr 7 mo	ProductU-3108
10058536*PED	Sep 30, 2036	in 10 yr 1 mo

Approval history

FDA approval span

First approval

Jun 28, 2012

14 yr 6 mo ago

Most recent approval

May 01, 2026

5 mo ago

Approvals span 2012–2026 across 12 FDA applications.

Brand (NDA) 217%

Generic (ANDA) 1083%

Mirabegron: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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