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Last Updated: January 18, 2021

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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, Cipla, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Reddys, Sandoz, Twi Pharms, Wockhardt, Zydus Pharms, and Toprol, and is included in twenty 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-three 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

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SponsorPhase
University of PennsylvaniaPhase 4
Qilu Hospital of Shandong UniversityN/A
Region of Southern DenmarkPhase 4

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Pharmacology 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
Novast Labs METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 204106-001 Feb 6, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 202033-002 Dec 15, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Reddys METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 078889-002 Aug 15, 2012 AB RX No No   Start Trial   Start Trial   Start 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 019962-004 Feb 5, 2001   Start Trial   Start Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-001 Jan 10, 1992   Start Trial   Start Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-002 Jan 10, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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