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Last Updated: October 23, 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, Alkem Labs Ltd, Cipla, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Reddys, Sandoz, Twi Pharms, 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-six 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
Medical University of GdanskPhase 3
National Institute on Aging (NIA)Phase 4
The New York Community TrustPhase 4

See all METOPROLOL SUCCINATE clinical trials

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
Nesher Pharms METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 076640-002 May 18, 2007 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Cipla METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 207465-002 Oct 26, 2018 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Dr Reddys Labs Ltd METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 090617-002 Aug 1, 2012 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Spil KAPSPARGO SPRINKLE metoprolol succinate CAPSULE, EXTENDED RELEASE;ORAL 210428-004 Jan 26, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-002 Jan 10, 1992 ⤷  Try it Free ⤷  Try it Free
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-002 Jan 10, 1992 ⤷  Try it Free ⤷  Try it Free
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-002 Jan 10, 1992 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
Express Scripts
Harvard Business School
Moodys
Baxter

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