Pharsight

1. Myrbetriq patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP09817723A	2021-09-30	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP09817723A	2021-09-30	Brand Murray Fuller LLP	Granted and Under Opposition
EP09817723A	2021-09-29	Bülle Dr., Jan	Granted and Under Opposition
EP09817723A	2021-09-29	Hamm&Wittkopp Patentanwälte PartmbB	Granted and Under Opposition
EP09817723A	2021-09-29	Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi	Granted and Under Opposition
EP09817723A	2021-09-23	Sandoz AG	Granted and Under Opposition
EP08843784A	2013-07-17	Huenges Martin/, Glas Holger	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US6346532	October, 2017	Terminated-Denied	Astellas Pharma Inc.	Sawai Pharmaceutical Co., Ltd.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6346532	APGDI	Amide derivatives or salts thereof	Mar, 2022 (1 year, 6 months ago)
US7342117	APGDI	α-form or β-form crystal of acetanilide derivative	Nov, 2023 (a month from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6346532 (Pediatric)	APGDI	Amide derivatives or salts thereof	Sep, 2022 (1 year, 3 days ago)
USRE44872	APGDI	Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient	Nov, 2023 (a month from now)
US8835474	APGDI	Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient	Nov, 2023 (a month from now)
US7982049	APGDI	α-form or β-form crystal of acetanilide derivative	Nov, 2023 (a month from now)
USRE44872 (Pediatric)	APGDI	Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient	May, 2024 (7 months from now)
US8835474 (Pediatric)	APGDI	Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient	May, 2024 (7 months from now)
US7982049 (Pediatric)	APGDI	α-form or β-form crystal of acetanilide derivative	May, 2024 (7 months from now)
US7342117 (Pediatric)	APGDI	α-form or β-form crystal of acetanilide derivative	May, 2024 (7 months from now)
US8772315	APGDI	Pharmaceutical composition for treating overactive bladder	Oct, 2028 (5 years from now)
US8772315 (Pediatric)	APGDI	Pharmaceutical composition for treating overactive bladder	Apr, 2029 (5 years from now)
US10842780	APGDI	Pharmaceutical composition for modified release	Sep, 2029 (5 years from now)
US11707451	APGDI	Pharmaceutical composition for modified release	Sep, 2029 (5 years from now)
US11707451 (Pediatric)	APGDI	Pharmaceutical composition for modified release	Mar, 2030 (6 years from now)
US10842780 (Pediatric)	APGDI	Pharmaceutical composition for modified release	Mar, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication (I)	Mar 25, 2024
Pediatric Exclusivity (PED)	Sep 25, 2024

Drugs and Companies using MIRABEGRON ingredient

Market Authorisation Date: 28 June, 2012

Treatment: For the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency; Use in combination with the muscarinic antagonist solifenacin succinate for th...

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg	28 Jun, 2016	6	27 Dec, 2019	04 Nov, 2023	Extinguished Eligible
50 mg	28 Jun, 2016	6	28 Sep, 2022	04 Nov, 2023	Deferred

Strength	Dosage	Availability
25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription

MYRBETRIQ family patents

2. Myrbetriq Granules patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US6346532	October, 2017	Terminated-Denied	Astellas Pharma Inc.	Sawai Pharmaceutical Co., Ltd.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6346532	APGDI	Amide derivatives or salts thereof	Mar, 2022 (1 year, 6 months ago)
US7342117	APGDI	α-form or β-form crystal of acetanilide derivative	Nov, 2023 (a month from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6346532 (Pediatric)	APGDI	Amide derivatives or salts thereof	Sep, 2022 (1 year, 3 days ago)
US7982049	APGDI	α-form or β-form crystal of acetanilide derivative	Nov, 2023 (a month from now)
US7342117 (Pediatric)	APGDI	α-form or β-form crystal of acetanilide derivative	May, 2024 (7 months from now)
US7982049 (Pediatric)	APGDI	α-form or β-form crystal of acetanilide derivative	May, 2024 (7 months from now)
US10058536	APGDI	Pharmaceutical composition containing mirabegron	Mar, 2036 (12 years from now)
US10058536 (Pediatric)	APGDI	Pharmaceutical composition containing mirabegron	Oct, 2036 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product (NP)	Mar 25, 2024
Pediatric Exclusivity (PED)	Sep 25, 2024

Drugs and Companies using MIRABEGRON ingredient

Market Authorisation Date: 25 March, 2021

Treatment: Treatment of neurogenic detrusor overactivity (ndo) in pediatric patients aged 3 years and older by administration of an extended-release suspension formulation of mirabegron

Dosage: FOR SUSPENSION, EXTENDED RELEASE;ORAL