Viewing data from:

MIRABEGRON

ANDA

MIRABEGRON | A209485 | LUPIN LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MYRBETRIQ(TE code: AB)

Hatch-Waxman Litigation

3 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Astellas Pharma Inc. et al v. Aurobindo Pharma Ltd. et al 1:2021cv00425 1 patentANDA 209413, 209368, 209488, 209485mirabegron	D. Del.	2021-03-24	Active	—
Astellas Pharma Inc. et al v. Sandoz Inc. et al 1:2020cv01589 5 patentsANDA 209441, 209368, 209434, 209413, 209446, 209475, 209428, 209488, 209485mirabegron	D. Del.	2020-11-24	Terminated 2026-02-19	—
Astellas Pharma Inc. et al v. Lupin Ltd. et al 1:2016cv00908 5 patentsANDA 209485mirabegron	D. Del.	2016-10-07	Terminated 2020-04-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain36 active DMFs1 inactive

34 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDMIRABEGRON [ROUTE CODE "MG"]

DMF 280712014

DR REDDYS LABORATORIES LTDMIRABEGRON [PRODUCT CODE: AEB]

DMF 283922014

DR REDDYS LABORATORIES LTDMIRABEGRON [FORM - AMORPHOUS]

DMF 290642015

MICRO LABS LTDMIRABEGRON

DMF 297342015

MEGAFINE PHARMA P LTDMIRABEGRON DRUG SUBSTANCE

DMF 297732015

LUPIN MANUFACTURING SOLUTIONS LTDMIRABEGRON

DMF 299252015

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDMIRABEGRON

DMF 300302015

ALIVUS LIFE SCIENCES LTDMIRABEGRON

DMF 300652016

APITORIA PHARMA PRIVATE LTDMIRABEGRON

DMF 300862015

ZYDUS LIFESCIENCES LTDMIRABEGRON

DMF 301052016

SOLARA ACTIVE PHARMA SCIENCES LTDMIRABEGRON

DMF 301692016

HETERO DRUGS LTDMIRABEGRON (FORM-B)

DMF 302912016

JIANGXI SYNERGY PHARMACEUTICAL CO LTDMIRABEGRON

DMF 316612017

SYNTHON BVMIRABEGRON

DMF 324402018

DELMAR CHEMICALS INCMIRABEGRON

DMF 329292018

PIRAMAL PHARMA LTDMIRABEGRON

DMF 332812018

UNICHEM LABORATORIES LTDMIRABEGRON

DMF 335032019

JUBILANT PHARMOVA LTDMIRABEGRON

DMF 335162019

COHANCE LIFESCIENCES LTDMIRABEGRON

DMF 338212019

BIOCON LTDMIRABEGRON

DMF 351172020

VIWIT PHARMACEUTICAL CO LTDMIRABEGRON

DMF 359802021

MSN LABORATORIES PRIVATE LTDMIRABEGRON (a-FORM)

DMF 366822022

VASUDHA PHARMA CHEM LTDMIRABEGRON IH

DMF 366852022

CIPLA LTDMIRABEGRON

DMF 367782022

METROCHEM API PRIVATE LTDMIRABEGRON

DMF 369732022

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDMIRABEGRON

DMF 378002022

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDMIRABEGRON

DMF 381562023

CHEMO SMS ENTERPRISE SLMIRABEGRON

DMF 386122023

NEULAND LABORATORIES LTDMIRABEGRON

DMF 387702023

AMOLI ORGANICS PVT LTDMIRABEGRON

DMF 388252023

MACLEODS PHARMACEUTICALS LTDMIRABEGRON

DMF 395262024

MEHTA API PVT LTDMIRABEGRON EP

DMF 404022024

AMI LIFESCIENCES PRIVATE LTDMIRABEGRON

DMF 404212024

SYNTHIMED LABS PRIVATE LTDMIRABEGRON

DMF 413902025

RAKSHIT DRUGS PRIVATE LTDMIRABEGRON

DMF 421002025

AARTI PHARMALABS LTDMIRABEGRON

DMF 425902025

DR REDDYS LABORATORIES LTDInactiveMIRABEGRON PREMIX

DMF 304132016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 28, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 28, 2022

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 28, 2022