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Last Updated: January 18, 2021

DrugPatentWatch Database Preview

TOPROL-XL Drug Profile

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When do Toprol-xl patents expire, and when can generic versions of Toprol-xl launch?

Toprol-xl is a drug marketed by Toprol and is included in one NDA.

The generic ingredient in TOPROL-XL is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

US ANDA Litigation and Generic Entry Outlook for Toprol-xl

A generic version of TOPROL-XL was approved as metoprolol succinate by ACTAVIS LABS FL INC on August 3rd, 2009.

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Drug patent expirations by year for TOPROL-XL
Recent Clinical Trials for TOPROL-XL

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SponsorPhase
BioHealthonomics Inc.Phase 2
Food and Drug Administration (FDA)Phase 4
University of FloridaPhase 4

See all TOPROL-XL clinical trials

Pharmacology for TOPROL-XL
Paragraph IV (Patent) Challenges for TOPROL-XL
Tradename Dosage Ingredient NDA Submissiondate
TOPROL-XL TABLET, EXTENDED RELEASE;ORAL metoprolol succinate 019962

US Patents and Regulatory Information for TOPROL-XL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-004 Feb 5, 2001 AB RX Yes No   Start Trial   Start Trial   Start Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-003 Jan 10, 1992 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-001 Jan 10, 1992 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-002 Jan 10, 1992 AB RX Yes 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 TOPROL-XL

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
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 019962-003 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:

Harvard Business School
Express Scripts
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Dow
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