FDA Orange Book
Generic for Myrbetriq Granules
Myrbetriq Granules 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 Granules is mirabegron. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Myrbetriq Granules products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, extended release, oral | 8MG/ML | Marketed (Rx) | AB | 1 | AB |
NDA 213801, 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALKEM LABORATORIES LTD | 219323 | AB (A-rated, therapeutically equivalent) | January 20, 2026 | 8MG/ML |
Myrbetriq Granules patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10058536 | March 31, 2036 | Drug product | U-3108 | 213801 |
| 10058536*PED | September 30, 2036 | Method of use | None | 213801 |
Myrbetriq Granules NDC codes
Questions
Is there a generic for Myrbetriq Granules?
Yes. The generic name for Myrbetriq Granules is mirabegron. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Myrbetriq Granules?
The active ingredient in Myrbetriq Granules is mirabegron, per the FDA Orange Book.
When does the Myrbetriq Granules patent expire?
The last patent listed for Myrbetriq Granules in the Orange Book expires September 30, 2036. 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.