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Last Updated: April 28, 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.

Summary for METOPROLOL SUCCINATE

International Patents:	8
US Patents:	2
Tradenames:	3
Applicants:	23
NDAs:	28
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	57
Patent Applications:	2,199
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for METOPROLOL SUCCINATE
Drug Sales Revenues:	Drug sales revenues for METOPROLOL SUCCINATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METOPROLOL SUCCINATE
What excipients (inactive ingredients) are in METOPROLOL SUCCINATE?	METOPROLOL SUCCINATE excipients list
DailyMed Link:	METOPROLOL SUCCINATE at DailyMed

See drug prices for METOPROLOL SUCCINATE

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

Sponsor	Phase
Cytokinetics	Phase 3
Yang I. Pachankis	Phase 4
Emory University	Phase 1/Phase 2

See all METOPROLOL SUCCINATE clinical trials

Pharmacology for METOPROLOL SUCCINATE

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

US Patents and Regulatory Information for METOPROLOL SUCCINATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-002	Jan 26, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-003	Jan 26, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Nesher Pharms	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	077779-001	Mar 20, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Elizabeth	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	204161-003	Nov 25, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Yichang Humanwell	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	213854-004	Aug 1, 2022	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	019962-003	Jan 10, 1992	⤷ Try a Trial	⤷ Try a Trial
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	019962-001	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for METOPROLOL SUCCINATE

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Country	Patent Number	Title	Estimated Expiration
Canada	2954474	FORME DOSIFIEE DE CAPSULE DE SUCCINATE DE METOPROLOL (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
Brazil	112017000468	forma de dosagem de cápsula de liberação prolongada	⤷ Try a Trial
Japan	6626492		⤷ Try a Trial
Mexico	2017000384	FORMA DE DOSIFICACION EN CAPSULAS DE SUCCINATO DE METOPROLOL. (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE.)	⤷ Try a Trial
Japan	2017523164	コハク酸メトプロロールのカプセル剤形	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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