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FDA Orange Book · active-ingredient family

Mirabegron

Mirabegron is approved as 2 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MYRBETRIQ GRANULES · NDA 213801

2

Brand (NDA)

10

Generics (ANDA)

12

Listed patents

0

Exclusivity periods

Brand (NDA) products · for suspension, extended release, tablet, extended release

ProductApplicantApplicationTEApproved
MYRBETRIQ GRANULESRLDAPGDINDA 213801ABMar 25, 2021
MYRBETRIQRLD×2APGDINDA 202611ABJun 28, 2012

Generic (ANDA) products (10)

ProductApplicantApplicationTEApproved
MIRABEGRON×2DEVA HOLDING ASANDA 219941ABMay 01, 2026
MIRABEGRONALKEM LABS LTDANDA 219323ABJan 20, 2026
MIRABEGRON×2MSNANDA 218543ABNov 04, 2025
MIRABEGRON×2QILUANDA 217989ABJun 30, 2025
MIRABEGRONSAWAI USAANDA 217061—May 06, 2025
MIRABEGRON×2APOTEXANDA 209434—Jan 02, 2025
MIRABEGRON×2ALKEM LABS LTDANDA 215948ABFeb 12, 2024
MIRABEGRON×2ZYDUS PHARMSANDA 209488ABSep 29, 2022
MIRABEGRON×2LUPINANDA 209485ABSep 28, 2022
MIRABEGRONSAWAI USAANDA 209446—Dec 27, 2019

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8772315Oct 30, 2028in 2 yr 5 mo
U-2300
8772315*PEDApr 30, 2029in 2 yr 11 mo
10842780Sep 28, 2029in 3 yr 4 mo
ProductU-3670
12097189Sep 28, 2029in 3 yr 4 mo
U-2996
11707451Sep 28, 2029in 3 yr 4 mo
U-2996
12059409Sep 28, 2029in 3 yr 4 mo
Product
11707451*PEDMar 28, 2030in 3 yr 10 mo
12097189*PEDMar 28, 2030in 3 yr 10 mo
10842780*PEDMar 28, 2030in 3 yr 10 mo
12059409*PEDMar 28, 2030in 3 yr 10 mo
10058536Mar 31, 2036in 9 yr 11 mo
ProductU-3108
10058536*PEDSep 30, 2036in 10 yr 5 mo

Mirabegron — frequently asked questions

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

Agent CTA Background

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