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Last Updated: March 19, 2024

METOPROLOL SUCCINATE - Generic Drug Details


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What are the generic drug sources for metoprolol succinate and what is the scope of freedom to operate?

Metoprolol succinate is the generic ingredient in three branded drugs marketed by Spil, Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alkem Labs Ltd, Cipla, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd Iii, Lupin, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Prinston Inc, Reddys, Sandoz, Sunshine, Visum Pharm, Wockhardt, Yichang Humanwell, Zydus Pharms, and Toprol, and is included in twenty-eight NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Metoprolol succinate has eight patent family members in seven countries.

There are thirty drug master file entries for metoprolol succinate. Forty-nine suppliers are listed for this compound.

Drug Prices for METOPROLOL SUCCINATE

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Drug Sales Revenue Trends for METOPROLOL SUCCINATE

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Recent Clinical Trials for METOPROLOL SUCCINATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CytokineticsPhase 3
Yang I. PachankisPhase 4
Emory UniversityPhase 1/Phase 2

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Pharmacology for METOPROLOL SUCCINATE

US Patents and Regulatory Information for METOPROLOL SUCCINATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Prinston Inc METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 210597-001 Jan 4, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd Iii METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 205541-003 Nov 6, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 203894-002 Mar 23, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 090617-001 Aug 1, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 203894-003 Mar 23, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 202033-003 Dec 15, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for METOPROLOL SUCCINATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-001 Jan 10, 1992 ⤷  Try a Trial ⤷  Try a Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-003 Jan 10, 1992 ⤷  Try a Trial ⤷  Try a Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-004 Feb 5, 2001 ⤷  Try a Trial ⤷  Try a Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-003 Jan 10, 1992 ⤷  Try a Trial ⤷  Try a Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-002 Jan 10, 1992 ⤷  Try a Trial ⤷  Try a Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-002 Jan 10, 1992 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for METOPROLOL SUCCINATE

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2016005934 ⤷  Try a Trial
Mexico 2017000384 FORMA DE DOSIFICACION EN CAPSULAS DE SUCCINATO DE METOPROLOL. (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE.) ⤷  Try a Trial
Japan 6626492 ⤷  Try a Trial
Brazil 112017000468 forma de dosagem de cápsula de liberação prolongada ⤷  Try a Trial
Australia 2015287299 Capsule dosage form of metoprolol succinate ⤷  Try a Trial
European Patent Office 3166599 FORME DOSIFIÉE DE CAPSULE DE SUCCINATE DE MÉTOPROLOL (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.