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Last Updated: January 16, 2022

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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, Actavis Elizabeth, Actavis Labs Fl Inc, Alkem Labs Ltd, Cipla, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Reddys, Sandoz, Visum Pharm, Wockhardt, Yichang Humanwell, Zydus Pharms, and Toprol, and is included in twenty-two 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 sixty drug master file entries for metoprolol succinate. Forty-four suppliers are listed for this compound.

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Drug Sales Revenue Trends for metoprolol succinate

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Recent Clinical Trials for metoprolol succinate

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SponsorPhase
Hackensack Meridian HealthEarly Phase 1
University of Texas Southwestern Medical CenterN/A
Medical University of GdanskPhase 3

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Pharmacology for metoprolol succinate
Anatomical Therapeutic Chemical (ATC) Classes for metoprolol succinate
Paragraph IV (Patent) Challenges for METOPROLOL SUCCINATE
Tradename Dosage Ingredient NDA Submissiondate
TOPROL-XL TABLET, EXTENDED RELEASE;ORAL metoprolol succinate 019962

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
Yichang Humanwell METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 213854-002 Feb 12, 2021 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-004 Feb 5, 2001 AB RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Spil KAPSPARGO SPRINKLE metoprolol succinate CAPSULE, EXTENDED RELEASE;ORAL 210428-004 Jan 26, 2018 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Actavis Labs Fl Inc METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 077298-002 Apr 15, 2010 DISCN No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Visum Pharm METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 207206-001 Dec 19, 2018 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Actavis Elizabeth METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 204161-001 Nov 25, 2016 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free 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 019962-002 Jan 10, 1992 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-003 Jan 10, 1992 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-004 Feb 5, 2001 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-002 Jan 10, 1992 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-002 Jan 10, 1992 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-001 Jan 10, 1992 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for metoprolol succinate

Country Patent Number Estimated Expiration
Japan 6626492 ⤷  Sign up for a Free Trial
World Intellectual Property Organization (WIPO) 2016005934 ⤷  Sign up for a Free Trial
Canada 2954474 ⤷  Sign up for a Free Trial
Brazil 112017000468 ⤷  Sign up for a Free Trial
Japan 2017523164 ⤷  Sign up for a Free Trial
European Patent Office 3166599 ⤷  Sign up for a Free Trial
>Country >Patent Number >Estimated Expiration

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